Trial Summary
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.
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.
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Treatment Details
Interventions
- StrataNGS (N/A)
- Systemic therapy (N/A)
Trial OverviewThe 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
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, San FranciscoSan Francisco, CA
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Who Is Running the Clinical Trial?
University of California, San FranciscoLead Sponsor
Strata OncologyIndustry Sponsor
Prostate Cancer FoundationCollaborator