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NCT02735252

PROMOTE: Identifying Predictive Markers of Response for Genitourinary Cancer

StatusActive, Not Recruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved 2 months later.

See at-risk trials from University of California, San Francisco

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Record History

All 16 versions: 14 with changes below, 2 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 29 words
    • Primary and study completion pushed from Mar 31, 2027 to May 31, 2027
    • Enrollment target: estimated 156 to confirmed 159
    • Secondary endpoints: details revised at 1 of 4 entries
  2. Primary and study completion dates: Jul 31, 2025 to Mar 31, 2027
    • Eligibility criteria revised
    • Secondary endpoints revised (4)
    v14
  3. Site details revisedv13
  4. Enrollment target: 750 to 156
    • Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Dec 31, 2025 to Jul 31, 2025
    • Site details revised
    v12
  5. Site contact updatedv11
Show 8 earlier versionsHide 8 earlier versions
  1. Site contact updatedv10
  2. Site contact updatedv9
  3. Primary and study completion dates pushed to Dec 31, 2025v8 Show 7 more changesShow less
    • Eligibility criteria expanded, about 135 words
    • Primary endpoints: 1 to 4
    • Enrollment target: 600 to 750
    • Secondary endpoints revised (4)
    • Study description expanded, about 31 words
    • Study title revised
    • Study arms: 8 to 10
  4. Eligibility criteria shortened, about 6 wordsv7
  5. Start date: Apr 7, 2016 to May 25, 2016
    • Eligibility criteria expanded, about 201 words
    • Interventions: Systemic therapy (Other) to StrataNGS (Device), Systemic therapy (Other)
    • Study arms: 6 to 8
    v6
  6. Primary completion date: Dec 2020 to Dec 2023
    • Study completion date: Dec 2021 to Dec 2024
    • Start date: Apr 2016 to Apr 7, 2016
    • Study description expanded, about 10 words
    v5
  7. Phase: Not specified to Not applicablev4 Show 7 more changesShow less
    • Lead sponsor: Eric Small to University of California, San Francisco
    • Eligibility criteria expanded, about 70 words
    • Enrollment target: 500 to 600
    • Study description expanded, about 33 words
    • Site contact updated
    • Study arms: 5 to 6
    • Collaborators expanded, about 5 words
  8. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Correlation of Treatment Benefit by group
Timeframe: Up to 5 years
Positive Predictive Value (PPV)
Timeframe: Up to 5 years
Median Progression-Free Survival (PFS)
Timeframe: Up to 5 years
Median Overall Survival (OS)
Timeframe: Up to 5 years

Secondary (4)

Prostate-specific antigen (PSA) Response Rate
Objective Response Rate (ORR)
Number of participants with presence of somatic mutations
Comparison of pathway activity signatures and overall survival

Arms and interventions

Group A: Androgen Signaling InhibitionExperimental

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 B: ImmunotherapyExperimental

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 C: RadiotherapyExperimental

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 D: Targeted Therapy Not Otherwise SpecifiedExperimental

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 E: DNA Damage ResponseExperimental

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 F: Aggressive Variant DiseaseExperimental

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 G1: Castration Sensitive, ADT naïve and ADT < 3 monthsExperimental

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 G2:Castration Sensitive,Pre-treated w/ sub-optimal PSAExperimental

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 R: Advanced Renal Cell CarcinomaExperimental

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.

Cohort U: Advanced Urothelial CarcinomaExperimental

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.

Other: Systemic therapy

Devices: StrataNGS

Sites

1 site in 1 country

  • University of California, San FranciscoSan Francisco, California, United States