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Predictive Marker Analysis for Prostate Cancer

N/A
Waitlist Available
Led By Rahul Aggarwal, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 yrs
History of histologically confirmed prostate cancer, or other advanced / metastatic genitourinary malignancies for cohorts R (renal cell carcinoma) and U (urothelial carcinoma)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is collecting tissues and blood from patients with metastatic prostate cancer and other genitourinary cancers to study how best to treat them.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While this trial primarily focuses on biomarker collection rather than direct intervention effects, potential side effects may arise from biopsy procedures such as bleeding or pain at the biopsy site. Systemic therapies used in various cohorts could also cause a range of side effects depending on the specific treatment administered.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I have a confirmed diagnosis of advanced prostate, kidney, or bladder cancer.
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I am able to get out of my bed or chair and move around.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Correlation of Treatment Benefit by group
Median Overall Survival (OS)
Median Progression-Free Survival (PFS)
+1 more
Secondary outcome measures
Comparison of pathway activity signatures and overall survival
Frequency of presence of somatic mutations
Objective Response Rate (ORR)
+1 more

Trial Design

10Treatment groups
Experimental Treatment
Group I: Group R: Advanced Renal Cell CarcinomaExperimental Treatment2 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 PSAExperimental Treatment2 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 monthsExperimental Treatment2 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 DiseaseExperimental Treatment2 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 ResponseExperimental Treatment2 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 SpecifiedExperimental Treatment2 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: RadiotherapyExperimental Treatment2 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: ImmunotherapyExperimental Treatment2 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 InhibitionExperimental Treatment2 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 CarcinomaExperimental Treatment2 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.

Find a Location

Who is running the clinical trial?

Strata OncologyIndustry Sponsor
5 Previous Clinical Trials
501,013 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,528 Previous Clinical Trials
15,242,476 Total Patients Enrolled
Prostate Cancer FoundationOTHER
48 Previous Clinical Trials
2,712 Total Patients Enrolled

Media Library

Systemic therapy (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT02735252 — N/A
Genitourinary Cancers Research Study Groups: Cohort U: Advanced Urothelial Carcinoma, Group B: Immunotherapy, Group E: DNA Damage Response, Group F: Aggressive Variant Disease, Group G2:Castration Sensitive,Pre-treated w/ sub-optimal PSA, Group G1: Castration Sensitive, ADT naïve and ADT < 3 months, Group A: Androgen Signaling Inhibition, Group D: Targeted Therapy Not Otherwise Specified, Group C: Radiotherapy, Group R: Advanced Renal Cell Carcinoma
Genitourinary Cancers Clinical Trial 2023: Systemic therapy Highlights & Side Effects. Trial Name: NCT02735252 — N/A
Systemic therapy (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02735252 — N/A
~14 spots leftby Jul 2025
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