Topic: Prostate Cancer

PCa Commentary | Volume 190 – June 2024

PCa Commentary | Volume 190 – June 2024

by | Jun 2024

Non-Metastatic Castration-Resistant Prostate Cancer:
Management Options, Associated Adverse Effects, and Treatment Outcomes.

‘Non-metastatic castration-resistant prostate cancer’ (nmCRPC) applies to a wide variety of patients with different risks for disease progression. It refers to patients who have had primary therapy intended for cure who then experience a rising PSA while receiving initial hormone suppression, i.e., nmCRPC. The ‘non-metastatic’ status designates that despite a rising PSA while on ADT conventional imaging with CT and bone scan is negative for metastatic spread. Among this ‘non-metastatic‘ category are men who have features likely associated with early development of metastatic disease i.e., PSA doubling time less than or equal to 10 months and Gleason score greater than or equal to 8. A treatment goal for this group would be to delay the occurrence of metastases, i.e., prolong metastases-free survival.

Non-metastatic castration-resistant prostate cancer in men with high-risk features is frequently metastatic on PSMA PET/CT scans.

This high-risk group was studied by Fendler et al, as reported in Clin Cancer Res. 2019. The study group comprised 200 men with high-risk nmCRPC who exhibited a rising PSA while on hormone suppression (ADT): i.e., PSA greater than 2 ng/ml., PSA doubling time in less than or equal to 10 months and Gleason score greater than or equal to 8. All were negative for metastatic disease on conventional CT and bone scans. When studied with PSMA PET scans, pelvic disease was found in 44%, of which 24% had recurrence in the prostate bed and 55% had cancer spread beyond the pelvis: extra-pelvic nodes, 39%; bone, 24% and viscera disease, 6%.

Treatment Options for Non-Metastatic CRPC:

1) Continue therapy with ADT until conventional imaging detects metastases and then augment ADT with second generation androgen receptor inhibitors (SGARi) – apalutamide, enzalutamide, darolutamide or the steroidogenesis inhibitor abiraterone or initiate a SGARi if the PSA doubling time is less than months.
2) Perform a PSMA PET scan and, upon detecting metastases, augment ADT with a SGARi. The establishment of metastatic CRPC opens additional therapeutic options: Provenge, Bipolar Androgen Therapy (BAT) or metastasis directed therapy (MDT).

A caveat: A thoughtful reflection on option #1 above was presented by Madan et al., Journal of Clinical Oncology, March 2024: “Restaging with Prostate-Specific Membrane Antigen Imaging in Metastatic Castration-Resistant Prostate Cancer: When Seeing More is Detrimental to Care.” They “seriously question if identifying subtle, likely subclinical changes on PSMA imaging translates into improving care” in patients with nmCRPC. Their recommendation is to base any therapeutic switch on disease progression exhibited on CT or bone scan. They note that in nmCRPC [i.e., early in the course of the disease] the PSA can rise over a duration of 17 months
without evidence of progression on conventional imaging. Madan’s position is that a premature switch of therapy based on a PSA rise, or PSMA imaged metastases, should be withheld until research data demonstrates a clinical gain, otherwise the patient is at risk for sustaining adverse side effects without a commensurate survival benefit. A comparison of PSMA and standard imaging in biochemically recurrent prostate cancer is underway in a Clinical Trial, NCT04777071.

Comparison of outcome and quality of life with systemic therapies in men with nmCRPC whose PSA doubling time is less than 10 months.

This was addressed by Shore et al. in “A multidisciplinary approach to address unmet needs in the management of patients with non-metastatic castration-resistant prostate cancer,” Prostate Cancer and Prostatic Disease, March 2024. Shore summarized the goals of treatment for nmCRPC as “delay or prevent metastatic disease and the need for additional antimetastatic treatment, maintain quality of life and prolong survival.” In short, in this high-risk group apalutamide, enzalutamide and darolutamide all increased
metastasis-free and overall survival when added to ADT. They all performed equivalently. The choice among the three is influenced by the adverse effects associated with each. Since there has been no “head-to-head” comparison, Shore’s article offers a consensus opinion based on “a panel of 10 multidisciplinary experts:”

Findings: Fatigue is a common feature of all three drugs: 32.6% for enzalutamide; 30.4%, apalutamide; 12.1% darolutamide — all greater compared to Lupron.

Other adverse effects:

apalutamide (Erleda) – rash, 23.8%; falls 15.6% seizures, 0.2%
darolutamide (Nubeqa) – back pain, 8.8%; arthralgia, 8.1%; seizures, 0.2%
enzalutamide  (Xtandi) – hot flashes, 13%; hypertension, 11.9%; falls, 11.4% and nausea, 11.4%. Seizure rate is comparably low.
Their comparison found “a stable long-term safety profile for darolutamide, whereas the likelihood… for serious adverse effects increased with apalutamide and enzalutamide.” Discontinuation of treatment was least likely with darolutamide, 33 months as compared to enzalutamide and apalutamide, 20.8 and 18.5 months, respectively. (George et al., JCO, 2023).

Drug-drug interactions are of significance and common in the older population commonly taking these drugs. The listing in the article is extensive. A consultation with a pharmacist is appropriate to evaluate and advise regarding a patient’s potential adverse drug-drug interactions.

To be noted: The high-risk for recurrence in the men studied in Fendler (above) and evaluated by Shore (also above) share similar high-risk features, suggesting that the ‘non-metastatic’ patients in Shore, if evaluated by PET/CT, would most likely be PET positive for metastatic CRPC.

A Counterintuitive relationship:  CT progression associated with a non-rising PSA in late disease.

Encompassed in the Shore article is the statement: “ … a substantial proportion of patients using SGARis may experience disease progression without rising PSA levels.”  This counterintuitive finding was reported initially and analyzed in 2017 in “Radiographic progression with non-rising PSA in metastatic castration-resistant prostate cancer: a post hoc analysis of [the] PREVAIL [trial]” (Bryce et al, Prostate Cancer and Prostatic Diseases, 2017). The PREVAIL trial compared enzalutamide to inert placebo pills in men with metastatic progression after initial hormone therapy as diagnosed by CT, bone scan and MRI. Bryce reported that “among 265
patients with radiographic progression, 65 (24.5%) had non-rising PSA levels.”

In their study, one-third of men with non-rising PSA, but with progression on imaging, had visceral disease, a common feature in men with neuroendocrine prostate cancer, either mixed with adenocarcinoma or pure NEPC. Whereas PSMA PET scans do not register NEPC because of the lack of the PSMA target, in CT scans the physical presence of lesions containing NEPC are
imaged.

With available data in 2017, Bryce et al. could only speculate that CT progression without PSA increase resulted from an admixture of adenocarcinoma and NEPC in which the NEPC lesions were CT apparent but not secreting PSA. In the future when the epigenetic test, “NEMO”, devised by Bartran (discussed in Commentary #187) becomes commercially available the extent of NEPC in this mixed situation can be assessed on circulating tumor DNA.

BOTTOM LINE:
Men with ‘non-metastatic’ CRPC at high risk for recurrence, when scanned with a PSMA PET, will be found to have metastatic CRPC in nearly all cases. Men designated as ‘nmCRPC’ and those men established as having metastases, are equally responsive to the addition of second-generation androgen receptor inhibitors when added to ongoing ADT.

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Advanced Prostate Cancer: Sequencing of Treatment

Advanced Prostate Cancer: Sequencing of Treatment

by | Jun 2024

Arnulf Stenzl, MD, discusses the challenges of appropriately sequencing advanced prostate cancer treatment and presents possible solutions. In his presentation, he addresses:

Recent and Anticipated Changes in Advanced Prostate Cancer Treatment
The Issue of Physician Information Overload
The Lack of Easily Accessible Comparative Data Between Agents
Possible Applications of Artificial Intelligence in Literature Searches

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Update on PROBASE Trial: Baseline PSA in Young Men (Aged 45 and 50)

Update on PROBASE Trial: Baseline PSA in Young Men (Aged 45 and 50)

by | May 2024

Peter Albers, MD, provides an update on the ongoing PROBASE trial, which examines the relationship between PSA tests and PCa overdiagnosis. He begins with an overview of the state of PCa screening, noting that there is no current standard practice for using PSA as a screening tool in younger patients.

Dr. Albers shares the background and design of the PROBASE trial, in which more than 46,000 participants were randomized into 2 risk-adapted arms, Immediate Screening and Deferred Screening. The Immediate Screening arm is composed of men who had their PSA levels tested at age 45. The Deferred Screening arm delayed PSA testing until age 50. 

After testing, participants in each arm of the trial were classified according to their PSA level. Participants with a PSA level of under 1.5 ng/ml were classified as Low-Risk and only required to repeat testing every 5 years, those with PSA levels between 1.5 and 2.99 ng/ml were considered “Intermediate-Risk” and were required to test every 2 years, and those with PSA levels of 3.0 ng/ml and above were considered “High-Risk” and sent for immediate MRI and biopsy.

Dr. Albers notes that 90% of participants were classified as “Low-Risk,” and have yet to be diagnosed with prostate cancer. In the High-Risk group, 40% were diagnosed with prostate cancer to date. 

Dr. Albers concludes by noting that future directions for the study may include investigating the value of MRI, genetic risk factors, the occurrence of other blood/urine-based biomarkers, and other “Smart Screening” mechanisms for early prostate cancer detection. Overall, he notes that the current data supports the hypothesis that PSA testing alone for early detection of prostate cancer creates overdiagnosis with minimal benefit and that risk-adapted screening is effective.

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PCa Commentary | Volume 189 – May 2024

PCa Commentary | Volume 189 – May 2024

by | May 2024

Non-Metastatic Castration-Resistant Prostate Cancer:
Management Options, Associated Adverse Effects, and Treatment Outcomes.

‘Non-metastatic castration-resistant prostate cancer’ (nmCRPC) applies to a wide variety of patients with different risks for disease progression. It refers to patients who have had primary therapy intended for cure who then experience a rising PSA while receiving initial hormone suppression, i.e., nmCRPC. The ‘non-metastatic’ status designates that despite a rising PSA while on ADT conventional imaging with CT and bone scan is negative for metastatic spread. Among this ‘non-metastatic‘ category are men who have features likely associated with early development of metastatic disease i.e., PSA doubling time less than or equal to 10 months and Gleason score greater than or equal to 8. A treatment goal for this group would be to delay the occurrence of metastases, i.e., prolong metastases-free survival.

Non-metastatic castration-resistant prostate cancer in men with high-risk features is frequently metastatic on PSMA PET/CT scans.

This high-risk group was studied by Fendler et al, as reported in Clin Cancer Res. 2019. The study group comprised 200 men with high-risk nmCRPC who exhibited a rising PSA while on hormone suppression (ADT): i.e., PSA greater than 2 ng/ml., PSA doubling time in less than or equal to 10 months and Gleason score greater than or equal to 8. All were negative for metastatic disease on conventional CT and bone scans. When studied with PSMA PET scans, pelvic disease was found in 44%, of which 24% had recurrence in the prostate bed and 55% had cancer spread beyond the pelvis: extra-pelvic nodes, 39%; bone, 24% and viscera disease, 6%.

Treatment Options for Non-Metastatic CRPC:

1) Continue therapy with ADT until conventional imaging detects metastases and then augment ADT with second generation androgen receptor inhibitors (SGARi) – apalutamide, enzalutamide, darolutamide or the steroidogenesis inhibitor abiraterone or initiate a SGARi if the PSA doubling time is less than months.
2) Perform a PSMA PET scan and, upon detecting metastases, augment ADT with a SGARi. The establishment of metastatic CRPC opens additional therapeutic options: Provenge, Bipolar Androgen Therapy (BAT) or metastasis directed therapy (MDT).

A caveat: A thoughtful reflection on option #1 above was presented by Madan et al., Journal of Clinical Oncology, March 2024: “Restaging with Prostate-Specific Membrane Antigen Imaging in Metastatic Castration-Resistant Prostate Cancer: When Seeing More is Detrimental to Care.” They “seriously question if identifying subtle, likely subclinical changes on PSMA imaging translates into improving care” in patients with nmCRPC. Their recommendation is to base any therapeutic switch on disease progression exhibited on CT or bone scan. They note that in nmCRPC [i.e., early in the course of the disease] the PSA can rise over a duration of 17 months
without evidence of progression on conventional imaging. Madan’s position is that a premature switch of therapy based on a PSA rise, or PSMA imaged metastases, should be withheld until research data demonstrates a clinical gain, otherwise the patient is at risk for sustaining adverse side effects without a commensurate survival benefit. A comparison of PSMA and standard imaging in biochemically recurrent prostate cancer is underway in a Clinical Trial, NCT04777071.

Comparison of outcome and quality of life with systemic therapies in men with nmCRPC whose PSA doubling time is less than 10 months.

This was addressed by Shore et al. in “A multidisciplinary approach to address unmet needs in the management of patients with non-metastatic castration-resistant prostate cancer,” Prostate Cancer and Prostatic Disease, March 2024. Shore summarized the goals of treatment for nmCRPC as “delay or prevent metastatic disease and the need for additional antimetastatic treatment, maintain quality of life and prolong survival.” In short, in this high-risk group apalutamide, enzalutamide and darolutamide all increased
metastasis-free and overall survival when added to ADT. They all performed equivalently. The choice among the three is influenced by the adverse effects associated with each. Since there has been no “head-to-head” comparison, Shore’s article offers a consensus opinion based on “a panel of 10 multidisciplinary experts:”

Findings: Fatigue is a common feature of all three drugs: 32.6% for enzalutamide; 30.4%, apalutamide; 12.1% darolutamide — all greater compared to Lupron.

Other adverse effects:

apalutamide (Erleda) – rash, 23.8%; falls 15.6% seizures, 0.2%
darolutamide (Nubeqa) – back pain, 8.8%; arthralgia, 8.1%; seizures, 0.2%
enzalutamide  (Xtandi) – hot flashes, 13%; hypertension, 11.9%; falls, 11.4% and nausea, 11.4%. Seizure rate is comparably low.
Their comparison found “a stable long-term safety profile for darolutamide, whereas the likelihood… for serious adverse effects increased with apalutamide and enzalutamide.” Discontinuation of treatment was least likely with darolutamide, 33 months as compared to enzalutamide and apalutamide, 20.8 and 18.5 months, respectively. (George et al., JCO, 2023).

Drug-drug interactions are of significance and common in the older population commonly taking these drugs. The listing in the article is extensive. A consultation with a pharmacist is appropriate to evaluate and advise regarding a patient’s potential adverse drug-drug interactions.

To be noted: The high-risk for recurrence in the men studied in Fendler (above) and evaluated by Shore (also above) share similar high-risk features, suggesting that the ‘non-metastatic’ patients in Shore, if evaluated by PET/CT, would most likely be PET positive for metastatic CRPC.

A Counterintuitive relationship:  CT progression associated with a non-rising PSA in late disease.

Encompassed in the Shore article is the statement: “ … a substantial proportion of patients using SGARis may experience disease progression without rising PSA levels.”  This counterintuitive finding was reported initially and analyzed in 2017 in “Radiographic progression with non-rising PSA in metastatic castration-resistant prostate cancer: a post hoc analysis of [the] PREVAIL [trial]” (Bryce et al, Prostate Cancer and Prostatic Diseases, 2017). The PREVAIL trial compared enzalutamide to inert placebo pills in men with metastatic progression after initial hormone therapy as diagnosed by CT, bone scan and MRI. Bryce reported that “among 265
patients with radiographic progression, 65 (24.5%) had non-rising PSA levels.”

In their study, one-third of men with non-rising PSA, but with progression on imaging, had visceral disease, a common feature in men with neuroendocrine prostate cancer, either mixed with adenocarcinoma or pure NEPC. Whereas PSMA PET scans do not register NEPC because of the lack of the PSMA target, in CT scans the physical presence of lesions containing NEPC are
imaged.

With available data in 2017, Bryce et al. could only speculate that CT progression without PSA increase resulted from an admixture of adenocarcinoma and NEPC in which the NEPC lesions were CT apparent but not secreting PSA. In the future when the epigenetic test, “NEMO”, devised by Bartran (discussed in Commentary #187) becomes commercially available the extent of NEPC in this mixed situation can be assessed on circulating tumor DNA.

BOTTOM LINE:
Men with ‘non-metastatic’ CRPC at high risk for recurrence, when scanned with a PSMA PET, will be found to have metastatic CRPC in nearly all cases. Men designated as ‘nmCRPC’ and those men established as having metastases, are equally responsive to the addition of second-generation androgen receptor inhibitors when added to ongoing ADT.

Read More
The Modern (Overlapping) Relationship Between Active Surveillance and Focal Therapy

The Modern (Overlapping) Relationship Between Active Surveillance and Focal Therapy

by | Apr 2024

Mark Emberton, MD, FRCS, discusses the overlap between active surveillance and focal therapy in modern prostate cancer treatment. He begins by arguing that the proliferation of MRIs, which can accurately identify previously non-visible lesions, makes active surveillance unviable as a default treatment, emphasizing the survival rates of patients on active surveillance.

Dr. Emberton then presents an example case of a patient presenting with a lesion and the options physicians have for treatment. He compares the risks and benefits of treating the patient with focal therapy or monitoring the patient with active surveillance.

Dr. Emberton concludes by addressing the role of patient choice in prostate cancer treatment. He notes that informed patients tend to prefer treatment over surveillance, with little to no long-term regret about the decision. Patients opting for active surveillance over focal treatment tend to regret their decision not to treat the lesion earlier.

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LuPSMA: Imaging-Based Patient Eligibility Role of Tumor Heterogeneity & FDG

LuPSMA: Imaging-Based Patient Eligibility Role of Tumor Heterogeneity & FDG

by | Apr 2024

Hossein Jadvar, MD, PhD, MPH, MBA, MSL, FACNM, FSNMMI, discusses imaging-based patient eligibility for Lutetium-177 Prostate-Specific Membrane Antigen (177Lu-PSMA) and the role of tumor heterogeneity and 18F-fluorodeoxyglucose (FDG) in treatment failure. He begins by reviewing a study on the prediction of time to hormonal-treatment failure in metastatic castration-sensitive prostate cancer with FDG positron emission tomography/computed tomography (PET/CT) and another study assessing the association of FDG PET/CT with overall survival in men with metastatic castration-resistant prostate cancer (mCRPC).

Dr. Jadvar addresses mCRPC tumor heterogeneity within and across tumors and prediction of discordance between Gallium-68-PSMA-11 therapy and FDG, citing the LuPSMA trial, the TheraP trial, and the VISION trial. He then shares data on PSMA heterogeneity in mCRPC related to circulating tumor cells (CTC), metastatic tumor burden, and response to targeted RLT.

Dr. Jadvar shares the European Association of Urology (EAU)-European Association of Nuclear Medicine (EANM) consensus statements that PSMA PET demonstration of PSMA expression should be mandatory before treating with 177Lu-PSMA RLT. He then shares patient case studies illustrating the pros and cons of FDG PET/CT in PSMA radiopharmaceutical therapy (RPT).

Dr. Jadvar concludes by emphasizing that PSMA PET should be mandatory before PSMA RPT. He reminds practitioners to carefully consider what is optimal vs. what is required vs. what is practical.

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PCa Commentary | Volume 188 – April 2024

PCa Commentary | Volume 188 – April 2024

by | Apr 2024

Prostate cancer is heterogeneous throughout  –  within the prostate are divergent clones of varying malignant potential vying for escape. Within and among metastatic sites heterogeneity reigns. This complex biology presents diagnostic challenges and complicates management decisions. This Commentary reviews a seminal article which comprehensively researched this issue and provides clinical insight.

“Reversible epigenetic alterations mediate PSMA expression heterogeneity in advanced metastatic prostate cancer,” Sayer, Haffner and 22 colleagues, JCI insight, Feb 2023.

The key to their findings is the powerful tool of “rapid autopsy” wherein the prostate and multiple metastases sites are extensively biopsied directly after a patient’s death. Although PSMA is extensively expressed in localize cancer, “imaging studies of metastatic castration-resistant prostate cancer have demonstrated that up to 30% of patients have PSMA-negative tumors.”  Of 52 men (339 sites evaluated) with metastatic disease 25% had no detectable PSMA at any site. (Prostate Specific Membrane Antigen is the cell surface protein found in varying intensity on prostate cells). 44% of men “showed heterogeneous PSMA expression across individual metastases”. A single lesion might have both high and low PSMA expressing cells with “33 (63%) cases harboring at least one PSMA negative site.” Some cells lacking PSMA expression exhibited a biomarker for neuroendocrine transformation (NE). A small percentage of cells (7%) lacked expression of both PSMA and neuroendocrine markers. This heterogeneity limits the diagnostic effectiveness of PSMA PET scans in imaging the totality of a patient’s metastatic disease burden and has consequences relating to radioligand targeting of PSMA with, i.e., 177-Lutetium-PSMA-617.

Additional complexity regarding PSMA expression was seen: “Notably, we observed focal PSMA staining of the tumor-associated vasculature in tumors lacking PSMA expression in tumor cells.”

The PSMA negative tumors inversely expressed an alternative surface antigen, MUC1 (aka CEACAM5), a neuroendocrine marker whose function is to suppress a cell’s differentiation toward maturity and promote tumor growth. Varying PSMA expression was seen in different organs with lower expression in liver lesions, higher levels in adrenal glands, as compared to middling levels in the prostate and bone metastases suggesting “an interplay between the tumor microenvironment of metastatic sites and PSMA expression.”

The Sayer research discovered a therapeutically relevant relationship: “Epigenetic therapies can restore and augment PSMA expression.” They noted that a suppressive tag (epigenetic methylation) on DNA at portions of the FOLH1 gene suppressed PSMA expression and that the available drug, vorinostat (Zolinza), a histone deacetylase inhibitor, can remove this tag and partially restore PSMA expression. The effect of this agent in reversing PSMA suppression was confirmed in experiments in mice. Taken all together, the combined use of this drug with radioligand targeting of PSMA with, i.e., 177-Lu-PSMA-617 (Pluvicto), might increase the effectiveness of this regimen. The mixture of PSMA and CEACAM5 among metastases suggested a regimen of “co-targeting” both antigens with appropriate radioligands.
PCa Commentary

What are the major take-away points from this elegant research?

Heterogeneity of clones within the prostate and among metastatic sites dilute the accuracy of single site biopsies to capture the dominant genomic character of the cancer on which risk assessment and treatment selection are made. Assaying circulating free tumor DNA or sequencing pooled biopsies can provide broader coverage. 
Response to radioligand therapy with 177-Lu-PSMA-617 (Pluvicto) is proportional to the intensity of PSMA expression in the prostate and metastatic sites, as imaged by PET scans with Pylarify and Ga-68-PSMA-11. A substantial number of metastatic sites show weak PSMA expression and 25% show no PSMA expression and would be expected to respond poorly or not at all to radioligand therapy.
In the Vision trial of 177-Lu-PSMA-617 in men with advanced metastatic prostate cancer only approximately 50% of men showed a >50% decline in PSA, an outcome explained by the heterogeneity of PSMA expression among metastases. The extent of heterogeneity of PSMA expression at earlier stages of disease has not been reported.
The extent of PSMA expression in metastatic lesions is inversely proportional to the expression of markers for neuroendocrine transformation, CEACAM5 / MUC1, suggesting applicability of co-targeting of PSMA and CEACAM5 / MUC1, when radioligands for the latter are effectively developed. MUC1 can be targeted with CAR-T and antibody-drug conjugate therapies.
Epigenetically silenced PSMA expression at the FOLH1 gene can be reversed with vorinostat, a histone deacetylase inhibitor, suggesting that the effectiveness of radioligand targeting of PSMA could be enhanced by combining radioligand therapy with vorinostat.
BOTTOM LINE:
Advanced research documenting the heterogeneity of PSMA and CEACAM5 expression in metastatic prostate cancer carries significant implications regarding the diagnostic and therapeutic effectiveness of PSMA targeting in advanced disease. A regimen for restoring decreased PSMA expression is presented.

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Industry Perspective: Illuccix® for Gallium-68-PSMA-11 PET Imaging of Prostate Cancer

Industry Perspective: Illuccix® for Gallium-68-PSMA-11 PET Imaging of Prostate Cancer

by | Apr 2024

In this Industry Perspective, supported by Telix Pharmaceuticals, Bradley Fehrenbach, MD, MBA, presents Illuccix® for 68Ga-PSMA-11 PET imaging of prostate cancer. Dr. Fehrenbach begins by listing the FDA-approved indications for the use of Illuccix® during initial prostate cancer staging, after biochemical recurrence of prostate cancer, and before treating mCRPC.

Dr. Fehrenbach reviews data supporting the high diagnostic value, reproducibility, and accuracy of Illuccix®. He presents studies demonstrating its high true-positive rate, its ability to detect clinically significant disease when PSA level is as low as 0.02 ng/ml, and high inter-reader agreement.

Dr. Fehrenback concludes by listing the clinical benefits and practical accessibility of Gallium radiotracers for PET scans. At the conclusion of his presentation, he briefly answers questions posed to him by the Program Chair.

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Focal Therapy is Now Ready for Prime Time

Focal Therapy is Now Ready for Prime Time

by | Apr 2024

Hashim Ahmed, MD, PhD, advocates for wider adoption of focal therapy (FT) as a treatment option for localized prostate cancer. Dr. Ahmed contends that by identifying and ablating the index lesion, FT can control disease with fewer side effects than radical therapy.

Dr. Ahmed outlines UK criteria for FT, explaining it is an alternative to radical therapy, not an alternative to active surveillance. He lists the side effects of radical therapy compared with those of FT. He cites “reassuring” survival data on FT and calls this important because the data does not support the concern of FT resulting in greater instances of metastasis.

Dr. Ahmed explains data on outcomes of focal cryotherapy before turning to a comparison of FT vs. radical therapy outcomes, with little difference in failure-free survival. Dr. Ahmed cites randomized studies that experienced significant dropout rates in their radical therapy arms compared to FT.

Dr. Ahmed concludes by reiterating why FT confers similar oncological outcomes and improved genitourinary function compared with radical therapy. He contends FT is a legitimate treatment option, with current outcomes now justifying FT’s use in standard care, highlighting that it avoids damage to collateral tissue and the resulting side effects.

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Industry Perspective: BioProtect Balloon Implant™ System

Industry Perspective: BioProtect Balloon Implant™ System

by | Apr 2024

In this Industry Perspective, supported by BioProtect, Daniel Y. Song, MD, compares the BioProtect Balloon Implant™ System to rectal gel spacers currently on the market. Dr. Song begins by presenting the composition, dimensions, and safety features of the balloon.

Dr. Song then compares the balloon’s features and implantation process to those of the two most readily available rectal gel spacers on the market. He notes that, unlike the gel spacers, the balloon creates predictable, reproducible, symmetrical results.

Dr. Song presents a step-by-step illustration of the implantation process for the BioProtect Balloon Implant™ System. He presents a video demonstration of an implantation via blunt dissection, which reduces the risk of rectal, capsular, and vascular infiltration. He adds that the balloon is simple to degrade, with 98% of the material degraded at the 6-month mark.

Dr. Song concludes by presenting the results of the BioProtect Multinational Pivotal Study. He compares the GI toxicities at 3 and 6 months of patients treated with rectal gel spacers versus those treated with the BioProtect Balloon Implant™ System. He demonstrates that the balloon achieves robust reduction in radiation dose, while being well-tolerated by patients and easy for healthcare professionals to implant and adjust.

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PI-RADS Standardization and Risk Assessment – Recent Advances and Future Plans

PI-RADS Standardization and Risk Assessment – Recent Advances and Future Plans

by | Mar 2024

Clare Tempany, MB BCh BAO, gives an overview of the role that Prostate Imaging Reporting And Data System (PI-RADS) standardization plays in the treatment and detection of prostate cancer. She begins by giving a history of the RADS program, which is overseen by the American College of Radiation, and the objectives of RAD programs overall.

Dr. Tempany then goes into detail about the PI-RADS program and its specific objectives. She discusses the need to change and update existing RADS, highlighting the lack of consensus on two significant studies that would prompt such changes.

Dr. Tempany concludes by reviewing the technical specifications, clarifications in interpretation criteria and the role of Bi-Parametiric MRI in PI-RADS. She finishes her talk by going over possible research opportunities and other exciting future plans.

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Focal Cryoablation

Focal Cryoablation

by | Mar 2024

Michael A. Gorin, MD, discusses the value of focal cryoablation as a treatment option for prostate cancer in modern practice. He begins by providing a brief overview of negative patient outcomes after whole-gland treatment, and the benefits of subtotal gland treatments in the form of focal ablation therapies like cryoablation and High Intensity Focused Ultrasound (HIFU) therapy.

Dr. Gorin notes that HIFU and cryoablation are the two most commonly used and studied modalities for prostate cancer treatment. He discusses the benefits and weaknesses of focal HIFU, with particular focus on the possibility of incomplete cancer treatment, and compares them to those of focal cryoablation.

Dr. Gorin presents the elements of focal cryoablation which reduce the risk of incomplete treatment. He presents current guidelines and devices for performing focal cryoablation which protect the patient against side effects, like urethral sloughing, which had been previously associated with cryotherapy.

Dr. Gorin concludes by demonstrating the long-term success rate for patients treated using focal cryoablation. He compares the QOL outcomes of focal cryoablation to those of HIFU, and presents a recording of a real focal cryoablation procedure.

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