Predictive Marker Analysis for Prostate Cancer

Overseen By UCSF Genitourinary Medical Oncology Recruitment

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: Androgen deprivation therapy

Disqualifiers: Bleeding disorders, Locally advanced disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: Up to 5 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to collect blood and tissue samples from individuals with advanced prostate cancer or related cancers to determine which treatments are most effective for different cancer types. The study examines various systemic therapies, such as immunotherapy and targeted therapies, to identify markers that predict who might benefit most. Patients with confirmed metastatic prostate, renal cell, or urothelial cancer who can undergo image-guided biopsies may be eligible to participate. As an unphased trial, this study provides patients the opportunity to contribute to groundbreaking research that could personalize future cancer treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on blood thinners like warfarin or aspirin, you may need to stop them before a biopsy. It's best to discuss your specific medications with the study team.

What prior data suggests that this protocol is safe for tissue and blood collection?

Research has shown that systemic therapies, which affect the whole body, have been tested for safety in treating prostate cancer. Studies indicate that patients generally tolerate these treatments well. For instance, one study comparing different treatments found a lower risk of severe side effects with some systemic therapies compared to others, such as those based on docetaxel, suggesting these therapies might be safer options.

Additionally, researchers have studied androgen signaling inhibitors and targeted therapies for their effectiveness and safety. These therapies aim to target cancer cells more precisely, and reports suggest they can offer significant benefits with manageable side effects.

Patients receiving immunotherapy, which boosts the immune system to fight cancer, have also shown promising safety results. While some patients may experience side effects, they tend to be less severe and less frequent than with traditional chemotherapy.

Overall, current studies support that systemic therapies, including those targeting DNA damage responses, are generally safe and well-tolerated by prostate cancer patients. However, discussing potential side effects and treatment options with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover new insights into prostate cancer treatments by studying predictive molecular markers. Unlike standard treatments such as surgery, radiation, or hormone therapy, this trial investigates how various therapies, including immunotherapy and targeted therapies affecting DNA damage response pathways, can be tailored based on individual molecular profiles. By analyzing tumor biopsies and blood samples, the trial seeks to identify which patients might benefit most from specific treatments, potentially leading to more personalized and effective therapy options in the future. This approach could revolutionize prostate cancer care by allowing for more precise treatment plans tailored to the unique characteristics of each patient's cancer.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research has shown that systemic therapies, which affect the whole body, can effectively treat prostate cancer. In this trial, investigators will assign participants to different treatment groups. Some groups will receive androgen signaling inhibitors, which successfully manage prostate cancer by blocking hormones that fuel cancer growth. Other groups will receive immunotherapy, which enhances the immune system to fight cancer and has shown promise in treating advanced bladder cancer by helping the body target and destroy cancer cells. These findings support the potential benefits of systemic therapies in treating various types of cancer within the trial's treatment groups. ^{6 7 8 9 10}

Who Is on the Research Team?

Rahul Aggarwal, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced genitourinary cancers, including prostate, kidney, and bladder cancer. Participants must have metastatic disease that can be biopsied and an ECOG performance status of 0-2, indicating they are fully active or at least ambulatory. They should understand the study and consent to participate. Specific cohorts require different treatments like hormone therapy for prostate cancer or systemic therapies for renal cell carcinoma.

Inclusion Criteria

My cancer has spread, and it's possible to take a biopsy of the spread area.

Ability to understand and the willingness to sign a written informed consent.

My blood clotting levels are within a safe range for a biopsy, and I can pause blood thinners if needed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Biopsy and Blood Collection

Tumor biopsies and blood collection are performed for comprehensive molecular analysis

1 week

1 visit (in-person)

Treatment

Participants receive treatment corresponding to their assigned cohort, initiated within 42 days following baseline tumor biopsy and/or research blood collection

Up to 5 years

Every 3 months (in-person)

Progression Assessment

At disease progression, optional repeat assessment for metastatic tumor biopsy and mandatory blood collection for analysis

Varies

Follow-up

Participants are monitored every 6 months for updates on disease status, post-study therapies, and survival status

Up to 5 years

Every 6 months (telephone or chart review)

What Are the Treatments Tested in This Trial?

Interventions

• StrataNGS
• Systemic therapy

Trial Overview The PROMOTE trial is collecting tissue and blood samples from patients with metastatic genitourinary cancers to identify markers predicting treatment response. It involves several cohorts based on disease type/status and planned therapy post-biopsy: hormonal inhibition, immunotherapy, radiotherapy, targeted/investigational therapy, DNA damage response pathway targeting drugs.

How Is the Trial Designed?

Group I: Group R: Advanced Renal Cell Carcinoma Experimental Treatment 2 Interventions

Tumor biopsies: required prior to treatment and optional at time of disease progression. Blood draws: required prior to treatment, every 3 months during treatment, and at time of disease progression. Molecular markers will be studied in patients receiving therapies that target DNA damage response pathways to identify predictors of benefit and/or response. Treatments are assigned per investigator discretion.

Group II: Group G2:Castration Sensitive,Pre-treated w/ sub-optimal PSA Experimental Treatment 2 Interventions

Tumor biopsies: required prior to treatment and optional at time of disease progression. Blood draws: required prior to treatment, every 3 months during treatment, and at time of disease progression. Molecular markers will be studied in patients receiving therapies that target DNA damage response pathways to identify predictors of benefit and/or response. Treatments are assigned per investigator discretion.

Group III: Group G1: Castration Sensitive, ADT naïve and ADT < 3 months Experimental Treatment 2 Interventions

Tumor biopsies: required prior to treatment and optional at time of disease progression. Blood draws: required prior to treatment, every 3 months during treatment, and at time of disease progression. Molecular markers will be studied in patients receiving therapies that target DNA damage response pathways to identify predictors of benefit and/or response. Treatments are assigned per investigator discretion.

Group IV: Group F: Aggressive Variant Disease Experimental Treatment 2 Interventions

Tumor biopsies: required prior to treatment and optional at time of disease progression. Blood draws: required prior to treatment, every 3 months during treatment, and at time of disease progression. Molecular markers will be studied in patients with variants of disease that display aggressive behavior to identify predictors of benefit and/or response. Treatments are assigned per investigator discretion.

Group V: Group E: DNA Damage Response Experimental Treatment 2 Interventions

Tumor biopsies: required prior to treatment and optional at time of disease progression. Blood draws: required prior to treatment, every 3 months during treatment, and at time of disease progression. Molecular markers will be studied in patients receiving therapies that target DNA damage response pathways to identify predictors of benefit and/or response. Treatments are assigned per investigator discretion.

Group VI: Group D: Targeted Therapy Not Otherwise Specified Experimental Treatment 2 Interventions

Tumor biopsies: required prior to treatment and optional at time of disease progression. Blood draws: required prior to treatment, every 3 months during treatment, and at time of disease progression. Molecular markers will be studied in patients receiving targeted therapy and investigational therapeutics to identify predictors of benefit and/or response. Treatments are assigned per investigator discretion.

Group VII: Group C: Radiotherapy Experimental Treatment 2 Interventions

Tumor biopsies: required prior to treatment and optional at time of disease progression. Blood draws: required prior to treatment, every 3 months during treatment, and at time of disease progression. Molecular markers will be studied in patients receiving radiotherapy to identify predictors of benefit and/or response. Treatments are assigned per investigator discretion.

Group VIII: Group B: Immunotherapy Experimental Treatment 2 Interventions

Tumor biopsies: required prior to treatment and optional at time of disease progression. Blood draws: required prior to treatment, every 3 months during treatment, and at time of disease progression. Molecular markers will be studied in patients receiving immunotherapy to identify predictors of benefit and/or response. Treatments are assigned per investigator discretion.

Group IX: Group A: Androgen Signaling Inhibition Experimental Treatment 2 Interventions

Tumor biopsies: required prior to treatment and optional at time of disease progression. Blood draws: required prior to treatment, every 3 months during treatment, and at time of disease progression. Molecular markers will be studied in patients receiving treatments that inhibit androgen signaling to identify predictors of benefit and/or response. Treatments are assigned per investigator discretion.

Group X: Cohort U: Advanced Urothelial Carcinoma Experimental Treatment 2 Interventions

Tumor biopsies: required prior to treatment and optional at time of disease progression. Blood draws: required prior to treatment, every 3 months during treatment, and at time of disease progression. Molecular markers will be studied in patients receiving therapies that target DNA damage response pathways to identify predictors of benefit and/or response. Treatments are assigned per investigator discretion.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Strata Oncology

Industry Sponsor

Trials

6

Recruited

58,700+

Prostate Cancer Foundation

Collaborator

Trials

52

Recruited

3,000+

Published Research Related to This Trial

Recent advancements have led to more therapies approved for castration-resistant prostate cancer, improving patient survival rates.

Current treatment guidelines mainly rely on clinical factors rather than molecular features, highlighting the need for new biomarkers to personalize treatment and minimize side effects and costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomarkers for the Management of Castration-Resistant Prostate Cancer: We Are Not There Yet. Petrylak, DP., Crawford, ED.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37339479/

Efficacy of Systemic Treatment in Prostate Cancer Patients ... The main and secondary outcomes of interest were overall survival and progression-free survival, respectively. Formal meta-analysis using fixed-effect model and ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2588931125000392

Outcomes of Focal Therapy for Localized Prostate Cancer Five-year radical and systemic treatment–free survival was 82% (95% CI: 75–88%). The pooled incidence of grade ≥3 AEs was 3% (95% CI: 2–5%). Pad ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2214122

Fifteen-Year Outcomes after Monitoring, Surgery, or ... Of the 40 men in whom metastases had been diagnosed at 10 years, 14% had died of prostate cancer in the active-monitoring group by 15 years as ...

4. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2802132

First-line Systemic Treatment Options for Metastatic ... The PEACE-1 trial found that the combination of AAP acetate and D caused a substantial delay in disease progression and a remarkable improvement ...

5. journals.lww.com journals.lww.com/md-journal/fulltext/2025/10100/systemic_treatment_of_metastatic.53.aspx

Systemic treatment of metastatic castration-sensitive... The results suggested that the multisystemic therapy combinations were more effective in improving patient prognosis and delaying castration- ...

6. mdpi.com mdpi.com/2072-6694/17/18/3032

Application of the STRATCANS Criteria to the MUSIC ... Conclusions: STRATCANS has a stepwise association with the risk of progression to ≥GG3 disease and time to definitive treatment among men on AS in the MUSIC ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11975195/

The 5‐year results of the Stratified Cancer Active ... The STRATCANS 5-year outcomes demonstrate that a simple risk stratified surveillance using a prognostically meaningful endpoint is safe, durable, has low ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04812366

Study Details | NCT04812366 | Genomic Biomarker- ... The objective of this study is to see if providing an appropriate therapy based on the genomic testing of prostate tumour tissue will result in an improved ...

9. urotoday.com urotoday.com/recent-abstracts/urologic-oncology/prostate-cancer/163423-application-of-the-stratcans-criteria-to-the-music-prostate-cancer-active-surveillance-cohort-a-step-towards-risk-stratified-active-surveillance.html

A Step Towards Risk-Stratified Active Surveillance. The STRATified CANcer Surveillance (STRATCANS) model risk-stratifies patients with prostate cancer (PC) on active surveillance (AS) into ...

10. researchgate.net researchgate.net/publication/354137646_Development_and_Validation_of_StrataNGS_a_Multiplex_PCR_Semiconductor_Sequencing-Based_Comprehensive_Genomic_Profiling_Test

Development and Validation of StrataNGS, a Multiplex ... Here we describe the development and validation of StrataNGS, a 429 gene, multiplex PCR/semiconductor sequencing-based CGP laboratory developed test performed ...