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Predictive Marker Analysis for Prostate Cancer

Q: Is there still a possibility for participants to join this experiment?

<p>According to clinicaltrials.gov, this trial is not presently recruiting patients. Initially posted on May 25th 2016 and last updated July 13th 2022, there are no roles available right now; however, 3406 other trials in the same area of research are currently open for applications.</p>

Q: What are the primary goals of this experiment?

<p>Over the course of five years, this study will principally monitor Median Progression-Free Survival (PFS). Secondary objectives include a Comparison of pathway activity signatures and overall survival as measured by Logrank test, ascertaining the Frequency of presence of somatic mutations in select genes through descriptive statistics for categorical data; plus an evaluation on Objective Response Rate (ORR) using either PCWG2 criteria or RECIST v1.1 depending on patient category.</p>

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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Group III: Group G1: Castration Sensitive, ADT naïve and ADT < 3 monthsExperimental Treatment2 Interventions

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

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

15,237,399 Total Patients Enrolled

Prostate Cancer FoundationOTHER

47 Previous Clinical Trials

2,624 Total Patients Enrolled

Strata OncologyIndustry Sponsor

5 Previous Clinical Trials

600,718 Total Patients Enrolled

Media Library

Systemic therapy (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT02735252 — N/A

Genitourinary Cancers Research Study Groups: Group E: DNA Damage Response, Group A: Androgen Signaling Inhibition, Group D: Targeted Therapy Not Otherwise Specified, Group F: Aggressive Variant Disease, Group B: Immunotherapy, Group G1: Castration Sensitive, ADT naïve and ADT < 3 months, Group G2:Castration Sensitive,Pre-treated w/ sub-optimal PSA, Cohort U: Advanced Urothelial Carcinoma, 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still a possibility for participants to join this experiment?

"According to clinicaltrials.gov, this trial is not presently recruiting patients. Initially posted on May 25th 2016 and last updated July 13th 2022, there are no roles available right now; however, 3406 other trials in the same area of research are currently open for applications."

Answered by AI

What are the primary goals of this experiment?

"Over the course of five years, this study will principally monitor Median Progression-Free Survival (PFS). Secondary objectives include a Comparison of pathway activity signatures and overall survival as measured by Logrank test, ascertaining the Frequency of presence of somatic mutations in select genes through descriptive statistics for categorical data; plus an evaluation on Objective Response Rate (ORR) using either PCWG2 criteria or RECIST v1.1 depending on patient category."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PROMOTE: Identifying Predictive Markers of Response for Genitourinary Cancer

2016. "PROMOTE: Identifying Predictive Markers of Response for Genitourinary Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02735252.