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The mean absorbed radiation dose to tumors was 8.9 Gy/GBq, compared with 0.27 Gy/GBq in the kidneys and 0.13 Gy/GBq in the salivary glands. 

Radioligand therapy shows promising safety in patients with mCRPC

There are also 60 sites in the process of launching the EAP.

Expanded Access Program for recombinant BCG launches at first US site

The method involves local delivery of the antibiotic gentamicin directly into the bladder tissue. 

Novel drug delivery approach shows promise for UTI 

This bill would cut funds for research projects in disease states such as prostate cancer, bladder cancer, kidney cancer, and interstitial cystitis.

House passes bill that includes 57% budget cut to medical research programs

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Authors

Treatments provide a targeted therapeutic strategy for metastatic
castration-resistant prostate cancer. 

PARP inhibitors: Treating mCRPC from a genetic basis 

Dr. De La Cerda provides an overview of a patient case involving a 68 year-old male presenting with severe back pain, with an analysis of the clinical presentation, workup, and medical history.

Bone Predominant mCRPC Patient Case

Video content above is prompted by the following:

What are your initial impressions of the case?

Video Series

The FDA has accepted a Biologics License Application (BLA) seeking approval of nivolumab (Opdivo) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20), or subcutaneous nivolumab, for the treatment of patients with all previously approved solid tumor indications for nivolumab as a monotherapy, monotherapy maintenance following completion of combination therapy with nivolumab plus ipilimumab (Yervoy), or in combination with chemotherapy or cabozantinib (Cabometyx).

Nivolumab is currently approved under several indications, including in combination with ipilimumab for the first-line treatment of patients with intermediate- or poor-risk advanced renal cell carcinoma (RCC), in combination with cabozantinib for the first-line treatment of patients with advanced RCC, for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy, and in combination with cisplatin and gemcitabine for the first-line treatment of patients with unresectable or metastatic urothelial carcinoma.

The FDA is set to have a decision regarding the subcutaneous nivolumab formulation on or by December 29, 2024.

 According to a news release from Bristol Myers Squibb,

 approval of the formulation would make it the first and only subcutaneously administered PD-1 inhibitor.

“We believe subcutaneous nivolumab has the potential to make a significant difference in the lives of patients, which is reinforced by the FDA’s acceptance of our application,” said Gina Fusaro, PhD, vice president, global program lead, Bristol Myers Squibb, in the news release.

 “Opdivo is a foundational PD-1 inhibitor approved for many different types of cancer, and our continued investment in research that puts patients first remains a priority. If approved by the FDA, the subcutaneous administration of nivolumab would provide patients and their physicians with a new option that delivers the same well-known benefits as IV Opdivo but with the improved convenience of an injection administered in 3 to 5 minutes rather than a 30-to-60-minute infusion.”

The BLA submission is supported by findings from the phase 3 CheckMate-67T trial (NCT04810078), in which subcutaneous nivolumab met the study’s co-primary end points by demonstrating noninferiority to intravenous (IV) nivolumab regarding time average nivolumab serum concentration over 28 days (C

; geometric mean ratio [GMR}, 2.098; 90% CI, 2.001-2.200) and minimum serum concentration at a steady state (C

Data from the study, which were presented at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, California,

 also showed that subcutaneous nivolumab demonstrated noninferiority to IV nivolumab in the key powered secondary end point of objective response rate (ORR). Specifically, the subcutaneous arm demonstrated an ORR of 24.2% (95% CI, 19.0-30.0) per blinded independent central review (BICR), compared with 18.2% (95% CI, 13.6-23.6) in the IV arm.

The safety profile for subcutaneous nivolumab was consistent with that of the IV formulation. Among patients who received the subcutaneous formulation, 8.1% experienced injection-site reactions, with all being low-grade and transient. Deaths due to study drug toxicity occurred in 3 patients in the subcutaneous arm and 1 patient in the IV arm. Most deaths that occurred during the study were due to disease progression.

In total, the phase 3, open-label CheckMate-67T trial enrolled 495 patients with advanced or metastatic ccRCC who had received prior systemic therapy. Patients were randomly assigned 1:1 to receive 1200 mg subcutaneous nivolumab plus rHuPH20 every 4 weeks (n = 248) or to 3 mg/kg IV nivolumab every 2 weeks (n = 247) for up to 2 years of treatment or until disease progression, unacceptable toxicity, withdrawal, or death.

The co-primary pharmacokinetic end points for noninferiority testing were C

 of subcutaneous nivolumab vs IV nivolumab. The key secondary end point was ORR per BICR.

Final completion of the CheckMate-67T study is expected in January 2026.

1. U.S. Food and Drug Administration accepts Bristol Myers Squibb’s application for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. Bristol Myers Squibb. May 6, 2024. Accessed May 7, 2024. https://news.bms.com/news/corporate-financial/2024/U.S.-Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-Application-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

2. Bristol Myers Squibb announces updated action date by the U.S. Food and Drug Administration for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. Published online and accessed May 21, 2024. https://investors.bms.com/iframes/press-releases/press-release-details/2024/Bristol-Myers-Squibb-Announces-Updated-Action-Date-by-the-U.S.-Food-and-Drug-Administration-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

3. George S, Bourlon TB, Chacon MR, et al. Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Pharmacokinetics (PK), efficacy, and safety results from CheckMate 67T. 

4. A study of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread (CheckMate-67T). ClinicalTrials.gov. Last updated March 1, 2024. Accessed May 7, 2024. https://clinicaltrials.gov/study/NCT04810078

The FDA is set to have a decision regarding the subcutaneous nivolumab formulation on or by December 29, 2024. 

News

FDA accepts BLA for subcutaneous nivolumab in solid tumors

A 35-year-old male from Sudan was hospitalized with a right obstructing 1-cm ureteral stone seen on KUB. The KUB also revealed curvilinear calcification in the bladder wall. The patient was taken to the operating room for ureteroscopy and laser lithotripsy.

During cystoscopy, a rim of calcification was seen along the right ureteric ridge (figure 1a). A biopsy of this area was taken with the pathology shown in figure 1b.

B. Squamous cell carcinoma of the bladder

A 35-year-old male from Sudan presented with a 1-cm obstructing ureteral stone and curvilinear calcification in the bladder wall, as seen on KUB imaging. The patient underwent ureteroscopy and laser lithotripsy. During cystoscopy, calcification was observed along the right ureteric ridge. A biopsy was performed on this area to further investigate the pathology. The findings from the biopsy are crucial for understanding the underlying condition contributing to the calcification and obstruction, which may have implications for the patient's treatment and management.

A 35-year-old male from Sudan was hospitalized with a right obstructing 1-cm ureteral stone seen on KUB. The KUB also revealed curvilinear calcification in the bladder wall. The patient was taken to the operating room for ureteroscopy and laser lithotripsy. During cystoscopy, a rim of calcification was seen along the right ureteric ridge. What is the diagnosis?

Residents Corner

Quiz: Sandy patch on cystoscopy

The first patient has been enrolled in the phase 3 PROSTATE-IQ trial (NCT06274047), assessing the ability of the ArteraAI Prostate Test to accurately identify patients who can safely reduce or avoid treatment with hormone therapy, Artera announced in a news release.

The goal of the trial is to improve quality of life for patients with low-risk disease by enabling them to reduce or avoid the adverse effects associated with androgen deprivation therapy (ADT). The study will include patients who have biochemical recurrence following prostatectomy.

“We are excited to partner with some of the world’s leading institutions on this transformational clinical trial, one that can radically improve not only patient outcomes but the quality of life for men with prostate cancer,” said Tim Showalter, MD, chief medical officer of Artera, in a news release from the company.

 “There has been tremendous eagerness from the medical community to start adopting risk stratification tools in this fashion with this patient population—those with biochemical recurrence after prostatectomy. We’re excited to see our test being used to help determine the optimal treatment therapy, reduce unnecessary [adverse] effects, and increase confidence in treatment planning.”

In total, the PROSTATE-IQ trial plans to enroll 120 patients at up to 11 clinical trial sites across the US.

For the study, ArteraAI will be used to evaluate post-prostatectomy surgical specimens to stratify patients based on their risk. Patients deemed low risk will be randomly assigned to either 6 months of ADT or to apalutamide (Erleada) monotherapy. Those determined to be high risk will be randomly assigned to either 24 months of ADT or to 6 months of ADT with apalutamide.

The investigators will evaluate the ability to personalize treatment based on disease aggressiveness and determine whether apalutamide-based treatment can reduce fatigue and other adverse effects.

Patients are eligible for enrollment in the study if they have histologically confirmed prostate cancer, a prostate-specific antigen level of 0.1 ng/mL or higher following radical prostatectomy, an ECOG performance status of 2 or lower, and adequate organ function. Participants must also be older than 18 years and a candidate for salvage radiation and ADT treatment.

The primary outcome measure for the study is general quality of life, which according to Artera will be measured using questionnaires and wearable devices. This will include the Functional Assessment of Chronic Illness Therapy-Fatigue scale. The company also noted, “Secondary end points will include physician-reported toxicity, patient-reported activity, sleep, cognitive function, mental health, body composition changes, and cancer control metrics.”

Primary completion of the trial is expected for June 2027.

ArteraAI is a multimodal artificial intelligence biomarker test that uses patients’ digital biopsy images and clinical data to help predict which patients may benefit from a particular therapy. The prognostic test has been validated in patients who have undergone active surveillance, radiation therapy, or had a radical prostatectomy.

Across all National Comprehensive Cancer Network risk groups, the test can help to assess the risk of 10-year distant metastasis and prostate cancer-specific mortality. In lower-risk patients, the test can be used to evaluate the relative risk of adverse pathology at radical prostatectomy to help guide decisions surrounding active surveillance. In intermediate-risk patients, the test can help predict the benefit of adding short-term ADT to radiation therapy.

1. Artera announces 1st patient enrolled in PROSTATE-IQ trial to reduce burden of hormone therapy in men with prostate cancer recurrence after prostatectomy. News release. Artera. March 11, 2025. Accessed March 11, 2025. https://www.businesswire.com/news/home/20250311717751/en/Artera-Announces-1st-Patient-Enrolled-in-PROSTATE-IQ-Trial-to-Reduce-Burden-of-Hormone-Therapy-in-Men-with-Prostate-Cancer-Recurrence-After-Prostatectomy

2. PROSTATE-IQ: parallel randomized study of personalized apalutamide treatment and evaluation to improve quality of life in post-operative radiation with androgen axis suppression: a phase III multi-center study for men with detectable PSA after prostatectomy for prostate cancer. ClinicalTrials.gov. Updated November 12, 2024. Accessed March 11, 2025. https://clinicaltrials.gov/study/NCT06274047

3. Artera announces expansion of the ArteraAI Prostate Test to inform active surveillance decisions for lower risk prostate cancer patients. News release. Artera. August 6, 2024. Accessed March 11, 2025. https://www.businesswire.com/news/home/20240806340589/en/Artera-Announces-Expansion-of-the-ArteraAI-Prostate-Test-to-Inform-Active-Surveillance-Decisions-for-Lower-Risk-Prostate-Cancer-Patients

4. ArteraAI Prostate Test. Artera. Accessed March 11, 2025. https://artera.ai/for-clinicians

The goal of the trial is to improve quality of life by identifying patients who can safely reduce or avoid treatment with hormone therapy.

Phase 3 trial launches ArteraAI Prostate Test for treatment selection 

Use of the prostate-specific membrane antigen (PSMA) agent piflufolastat F 18 (

F-DCFPyL PET/CT, Pylarify) in patients with biochemically recurrent prostate cancer was associated with a high detection rate in patients with low prostate-specific antigen (PSA) levels, according to data presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, California.

In outlining the background for the study, the authors, led by Ida Sonni, MD, of the University of California, Los Angeles, explained that PSMA PET imaging has shown high sensitivity and specificity in the biochemically recurrent setting and “There is growing interest in using PSMA PET/CT for detecting and localizing [biochemical recurrence] in patients with low PSA levels (<0.5 ng/mL).” They also noted the paucity of literature regarding detection rates of PSMA PET radiotracers in the biochemical recurrent setting. To this end, the investigators sought to evaluate detection rates of 

F-DCFPyL in patients with biochemically recurrent prostate cancer who showed “minimally detectable serum PSA levels.”

The investigators conducted a pooled retrospective analysis of patients drawn from investigator-initiated trials at West Los Angeles Veterans Affairs and the phase 3 CONDOR trial (NCT03739684) who had serum PSA levels of 0.5 ng/mL or lower. For the analysis, patients with rising PSA levels following definitive treatment for their prostate cancer underwent 

F-DCFPyL PET/CT and were placed in 1 of 2 groups: low PSA (0.2 ng/mL- ≤0.5 ng/mL) or ultralow PSA (0 ng/mL-<0.2 ng/mL). The automated deep learning-enabled Prostate Cancer Molecular Imaging Standardized Evaluation platform was used to aid in 

F-DCFPyL PET/CT reads. The investigators defined detection rate as “the number of patients with positive PSMA lesions relative to total number of patients.”

The investigators included 129 patients in the study; 93 were in the low-PSA group, and 36 were in the ultralow PSA group. Total detection rate was 36% (13/36) in the ultralow PSA group and 51% (47/93) in the low-PSA group. Findings in the prostate bed were identified in 8% (3 patients) of the ultralow PSA group and 4% (4 patients) of the low-PSA group. Lymph node-only findings were identified in 14% (5 patients) of the ultralow PSA group and 31% (29 patients) of the low-PSA group. Lymph node and bone findings were identified in 33% (12 patients) of the ultralow PSA group and 42% (39 patients) of the low-PSA group. Bone-only findings were identified in 22% (8 patients) of the ultralow PSA group and 15% (14 patients) of the low-PSA group. Visceral (lung or liver) findings were identified in 3% (1 patient) in the ultralow PSA group and 11% (10 patients) in the low-PSA group. Total mean standard uptake value was 3.8 in the ultralow PSA group and 4.2 in the low-PSA group. Total maximum standard update value was 10.9 in the ultralow PSA group and 12.4 in the low-PSA group. Mean total disease volume was 4.9 mL in the ultralow PSA group and 1.9 mL in the low-PSA group.

F-DCFPyL PET/CT demonstrates a significant detection rate for recurrent prostate cancer in patients with minimally detectable PSA levels. Our findings highlight the potential of 

F-DCFPyL PET/CT in the early identification of metastatic disease. Current thresholds for initiating PSMA PET/CT in patients with [biochemical recurrence] may need reconsideration,” the authors wrote in their conclusion.

1. Sonni I, Nickols NG, Niknam K, et al. Early detection of recurrent prostate cancer using 18F-DCFPyL PET/CT PET/CT in patients with minimal PSA levels.

 2025;43(suppl 5). Abstract 344. doi:10.1200/JCO.2025.43.5_suppl.344

The use of the PSMA agent piflufolastat F 18 (18F-DCFPyL PET/CT) in patients with biochemically recurrent prostate cancer shows a high detection rate, even at low PSA levels. A study presented at the 2025 ASCO Genitourinary Cancers Symposium analyzed 129 patients with PSA levels ≤0.5 ng/mL. Detection rates were 36% in the ultra-low PSA group and 51% in the low-PSA group. The findings suggest that 18F-DCFPyL PET/CT could be valuable for early identification of metastatic disease, potentially prompting a reevaluation of current PSMA PET/CT initiation thresholds.

Total detection rate was 36% (13/36) in the ultralow PSA group and 51% (47/93) in the low-PSA group. 

Piflufolastat F18 yields high detection rate even at low PSA levels for prostate cancer

Preliminary findings from the PYLARIFY registry (NCT05712473) highlight the real-world clinical utility of piflufolastat F18 and the impact of scans on a clinician’s treatment management decisions.

Piflufolastat F18 was approved by the FDA in May 2021 for PET imaging of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer.

Data from the registry, which is collecting findings on the real-world clinical utility of the agent, were presented at the 

2025 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium

The results encompassed the first 100 patients enrolled in the study. Of these, 40 patients had newly diagnosed prostate cancer and had not yet received any treatment (cohort 1), and 60 patients were undergoing scans for biochemical recurrence (cohort 2). The median age of participants was 70.7 years and 71.3 years, respectively.

In total, 10% of patients in cohort 1 and 77% of patients in cohort 2 received at least 1 conventional imaging procedure prior to piflufolastat F18. The average number of conventional imaging procedures per patient was 1 and 1.58 in each cohort, respectively. The most common conventional imaging modalities used prior to piflufolastat F18 across both cohorts were CT (80%), skeletal scintigraphy (72%), and PET (26%).

In cohort 1, those who underwent both piflufolastat F18 and conventional imaging had an added 28 days to the length of their diagnostic journey compared with those who only underwent piflufolastat F18.

Data also showed the impact of piflufolastat F18 imaging on management plans. In cohort 1, piflufolastat F18 scans led to treatment escalation in 30% of patients, treatment de-escalation in 15% of patients, and no change in 55% of patients. In cohort 2, piflufolastat F18 scans led to treatment escalation in 57% of patients, treatment de-escalation in 17% of patients, and no change in 27% of patients.

Overall, 96% of clinicians strongly agreed (53%) or agreed (43%) that piflufolastat F18 improved their confidence in their treatment decision-making. The remaining respondents neither agreed nor disagreed with the statement.

In total, the multicenter, prospective, observational PYLARIFY registry plans to enroll up to 500 patients in the US across both cohorts.

 To be eligible for enrollment, patients need to be at least 21 years of age and eligible for a PSMA/PET scan. Participants must also have histopathological-confirmed prostate adenocarcinoma and a life expectancy of at least 6 months. Follow-up for each patient will occur for up to 5 years.

Among the first 100 patients enrolled in the study, 35% in cohort 1 and 26% in cohort 2 were Gleason grade 8 or higher at the time of diagnosis. Additionally, 90% of patients in cohort 1 and 74% of patients in cohort 2 were classified as being in the intermediate-to-high Gleason group at diagnosis. At diagnosis, 98% of patients in cohort 1 and 95% of patients in cohort 2 presented with non-metastatic hormone-sensitive prostate cancer.

Overall, 38% of patients in cohort 1 and 32% in cohort 2 were current or former smokers.

Data collection in the registry remains ongoing, with final completion expected in June 2029.

1. Shore ND, O’Donnell L, Wilson B, Dave SS, Kashyap A, Lazarou N. The role of conventional imaging and piflufolastat F18 in newly diagnosed and recurrent prostate cancer patients: preliminary observations from the PYLARIFY registry. 

. 2025;43(suppl 5). Abstract 41. doi:10.1200/JCO.2025.43.5_suppl.41

2. An observational registry assessing the impact of PYLARIFY (piflufolastat F18) PET in patients with prostate cancer. ClinicalTrials.gov. Updated February 3, 2023. Accessed February 20, 2025. https://clinicaltrials.gov/study/NCT05712473

Preliminary findings from the PYLARIFY Registry underscore the clinical utility of piflufolastat F18 in prostate cancer management. The study, involving 100 patients, revealed that piflufolastat F18 scans significantly influenced treatment decisions, with notable treatment escalations and de-escalations in both newly diagnosed and recurrent cases. Clinicians reported increased confidence in treatment planning due to these scans. The registry aims to enroll 500 patients, with ongoing data collection until 2029. The study highlights the potential of piflufolastat F18 to refine diagnostic and therapeutic strategies in prostate cancer care.

The results encompassed the first 100 patients enrolled in the registry.

Antony Mathew, MD

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