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

156 Participants Needed

Trial Summary

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 safety data exists for treatments related to predictive marker analysis in prostate cancer?

The research mentions that about 20% of patients undergoing docetaxel-based chemotherapy for metastatic castration-resistant prostate cancer experience early therapeutic failure due to adverse events (unwanted side effects). This highlights the importance of identifying patients who can tolerate the treatment to avoid unnecessary side effects. ^{1 2 3 4 5}

How does systemic therapy differ from other treatments for prostate cancer?

Systemic therapy for prostate cancer is unique because it involves using predictive biomarkers to tailor treatment to the individual, potentially improving outcomes by selecting therapies that are most likely to be effective and avoiding those that may cause unnecessary side effects. ^{6 7 8 9 10}

What is the purpose of this trial?

This is a tissue and blood collection protocol requiring image-guided biopsies of metastatic prostate cancer and other genitourinary malignancies including renal cell carcinoma and urothelial carcinoma. Whenever possible, a new bone lesion or new/progressing soft tissue lesion will be chosen for biopsy as opposed to radiographically stable lesion. Patients will be enrolled in into one of several parallel cohorts based upon disease status or type and the planned systemic therapy following baseline tumor biopsy: (A) Androgen signaling inhibition, (B) Immunotherapy, (C) Radiotherapy, (D) Targeted Therapy/Investigational therapeutic, (E) DNA damage response pathway, (F) Aggressive variant disease, (G1) Castration-sensitive ADT naïve and ADT \< 3 months), or (G2) Castration-sensitive pre-treated with sub-optimal PSA nadir \>0.2 ng/ml, (R) metastatic renal cell carcinoma and metastatic and (U) urothelial carcinoma.

Research Team

Rahul Aggarwal, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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.

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

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A 17-Gene Panel Genomic Prostate Score Has Similar Predictive Accuracy for Adverse Pathology at Radical Prostatectomy in African American and European American Men. [2022]

2. France pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Treatment Stratification of Patients with Metastatic Castration-Resistant Prostate Cancer by Machine Learning. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

New trial designs to assess antitumor and antiproliferative agents in prostate cancer. [2019]

5. Egypt pubmed.ncbi.nlm.nih.gov

Biomarker-based targeting of the androgen-androgen receptor axis in advanced prostate cancer. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Putative tissue markers in prostate cancer*. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

The Present and Future of Biomarkers in Prostate Cancer: Proteomics, Genomics, and Immunology Advancements. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

A simple prognostic model involving prostate-specific antigen, alkaline phosphatase and albumin for predicting the time required to progress to castration-resistant prostate cancer in patients who received androgen deprivation therapy. [2018]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Biomarkers for Treatment Response in Advanced Prostate Cancer. [2021]

10. Ireland pubmed.ncbi.nlm.nih.gov

Early biochemical predictors of survival in intermediate and high-risk prostate cancer treated with radiation and androgen deprivation therapy. [2020]