PROMOTE: Identifying Predictive Markers of Response for Genitourinary Cancer
NCT ID: NCT02735252
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
156 participants
INTERVENTIONAL
2016-05-25
2027-03-31
Brief Summary
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Detailed Description
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Certain genomic sequencing will be performed by Strata Oncology.
Following biopsy and baseline peripheral blood collection, patients will be treated per investigator discretion, with treatment corresponding to assigned patient cohort and initiated within 42 days following baseline tumor biopsy and/or research blood collection. Patients will be evaluated for response to therapy per the standard of care for their specific disease type; such as with monthly serum PSA measurements (may be done at UCSF or at local laboratory) and/or restaging scans (bone scan + CT abdomen/pelvis) (UCSF or local radiology facility). Outcomes on treatment post-biopsy will be recorded, including maximal PSA decline, date of radiographic progression.
At the time of disease progression by Prostate Cancer Working Group 2 (PCWG2) criteria for prostate cancer patients, or by RECIST v1.1 for patients with metastatic renal or urothelial cancer, patients may undergo optional repeat assessment for metastatic tumor biopsy, along with mandatory blood collection for analysis of circulating tumor DNA and circulating tumor cells (CTCs). Following second biopsy at progression, patients should continue to be followed for response to subsequent therapy.
Patients will be followed every 6 months for updates on disease status including post-study therapies and survival status via telephone calls and/or chart review.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Group A: Androgen Signaling Inhibition
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.
Systemic therapy
Systemic therapy is selected by the physician and is not restricted by the study. Molecular testing will be performed on tissue and blood to identify patterns and relationships with clinical outcomes in each group.
StrataNGS
CLIA-approved assay that is being performed as part of standard of care genomic profiling of patients tumor biopsies. The product currently covers about 90 cancer genes and is able to pick up all the known mutations and other types of genetic alterations across them, he added
Group B: Immunotherapy
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.
Systemic therapy
Systemic therapy is selected by the physician and is not restricted by the study. Molecular testing will be performed on tissue and blood to identify patterns and relationships with clinical outcomes in each group.
StrataNGS
CLIA-approved assay that is being performed as part of standard of care genomic profiling of patients tumor biopsies. The product currently covers about 90 cancer genes and is able to pick up all the known mutations and other types of genetic alterations across them, he added
Group C: Radiotherapy
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.
Systemic therapy
Systemic therapy is selected by the physician and is not restricted by the study. Molecular testing will be performed on tissue and blood to identify patterns and relationships with clinical outcomes in each group.
StrataNGS
CLIA-approved assay that is being performed as part of standard of care genomic profiling of patients tumor biopsies. The product currently covers about 90 cancer genes and is able to pick up all the known mutations and other types of genetic alterations across them, he added
Group D: Targeted Therapy Not Otherwise Specified
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.
Systemic therapy
Systemic therapy is selected by the physician and is not restricted by the study. Molecular testing will be performed on tissue and blood to identify patterns and relationships with clinical outcomes in each group.
StrataNGS
CLIA-approved assay that is being performed as part of standard of care genomic profiling of patients tumor biopsies. The product currently covers about 90 cancer genes and is able to pick up all the known mutations and other types of genetic alterations across them, he added
Group E: DNA Damage Response
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.
Systemic therapy
Systemic therapy is selected by the physician and is not restricted by the study. Molecular testing will be performed on tissue and blood to identify patterns and relationships with clinical outcomes in each group.
StrataNGS
CLIA-approved assay that is being performed as part of standard of care genomic profiling of patients tumor biopsies. The product currently covers about 90 cancer genes and is able to pick up all the known mutations and other types of genetic alterations across them, he added
Group F: Aggressive Variant Disease
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.
Systemic therapy
Systemic therapy is selected by the physician and is not restricted by the study. Molecular testing will be performed on tissue and blood to identify patterns and relationships with clinical outcomes in each group.
StrataNGS
CLIA-approved assay that is being performed as part of standard of care genomic profiling of patients tumor biopsies. The product currently covers about 90 cancer genes and is able to pick up all the known mutations and other types of genetic alterations across them, he added
Group G1: Castration Sensitive, ADT naïve and ADT < 3 months
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.
Systemic therapy
Systemic therapy is selected by the physician and is not restricted by the study. Molecular testing will be performed on tissue and blood to identify patterns and relationships with clinical outcomes in each group.
StrataNGS
CLIA-approved assay that is being performed as part of standard of care genomic profiling of patients tumor biopsies. The product currently covers about 90 cancer genes and is able to pick up all the known mutations and other types of genetic alterations across them, he added
Group G2:Castration Sensitive,Pre-treated w/ sub-optimal PSA
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.
Systemic therapy
Systemic therapy is selected by the physician and is not restricted by the study. Molecular testing will be performed on tissue and blood to identify patterns and relationships with clinical outcomes in each group.
StrataNGS
CLIA-approved assay that is being performed as part of standard of care genomic profiling of patients tumor biopsies. The product currently covers about 90 cancer genes and is able to pick up all the known mutations and other types of genetic alterations across them, he added
Group R: Advanced Renal Cell Carcinoma
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.
Systemic therapy
Systemic therapy is selected by the physician and is not restricted by the study. Molecular testing will be performed on tissue and blood to identify patterns and relationships with clinical outcomes in each group.
StrataNGS
CLIA-approved assay that is being performed as part of standard of care genomic profiling of patients tumor biopsies. The product currently covers about 90 cancer genes and is able to pick up all the known mutations and other types of genetic alterations across them, he added
Cohort U: Advanced Urothelial Carcinoma
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.
Systemic therapy
Systemic therapy is selected by the physician and is not restricted by the study. Molecular testing will be performed on tissue and blood to identify patterns and relationships with clinical outcomes in each group.
StrataNGS
CLIA-approved assay that is being performed as part of standard of care genomic profiling of patients tumor biopsies. The product currently covers about 90 cancer genes and is able to pick up all the known mutations and other types of genetic alterations across them, he added
Interventions
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Systemic therapy
Systemic therapy is selected by the physician and is not restricted by the study. Molecular testing will be performed on tissue and blood to identify patterns and relationships with clinical outcomes in each group.
StrataNGS
CLIA-approved assay that is being performed as part of standard of care genomic profiling of patients tumor biopsies. The product currently covers about 90 cancer genes and is able to pick up all the known mutations and other types of genetic alterations across them, he added
Eligibility Criteria
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Inclusion Criteria
* Radiographic evidence of metastatic disease amenable to image-guided or excisional biopsy of a metastatic site. Soft-tissue as well as bony metastatic lesions will be considered acceptable. Participants with locally advanced disease only (where the biopsy would be of a prostatic mass) are NOT eligible. Biopsy of newly emerging or progressive metastases is desired and preferable to the biopsy of previously existing stable lesions whenever possible. Patients without lesion amenable to biopsy are still eligible, and have the option of re-assessment for potential of metastatic tumor biopsy upon progression as outlined in the study calendar.
* For participants with metastatic lesion amenable for biopsy:
* Platelets \> = 75,000/microliter (μl)
* Prothrombin time (PT) or international normalized ratio (INR) and activated partial thromboplastin time (aPTT) \< = 1.5 times the institutional upper limit of normal (ULN) within 14 days prior to biopsy.
* Patients on warfarin, aspirin, or other anti-coagulants are eligible provided they are deemed able to tolerate discontinuation of anti-coagulation prior to the biopsy as per usual standard of care. Conversion to low molecular weight heparin prior to biopsy is permitted per local standard operating procedures, provided there is agreement regarding the procedure between the treating physician, the interventional radiologist and the PI.
* Participants with significant congenital or acquired bleeding disorders (e.g type 3 von Wildebrand's disease, acquired bleeding factor inhibitors) are not eligible.
* Age \> 18 yrs
* Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
* Ability to understand and the willingness to sign a written informed consent.
* Progression on or following most recent systemic therapy given for:
* Metastatic Renal Cell Carcinoma (RCC) or metastatic urothelial carcinoma (UC) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or for metastatic castration resistant prostate cancer (mCRPC) by Prostate Cancer Working Group 2 (PCWG2) criteria, with progression as defined by one or more of the following:
1. PSA Progression: PSA level of at least 2 nanograms (ng)/milliliter (ml) which has risen on at least 2 separate measurements, at least one week apart (for prostate cancer participants only)
2. Disease progression by RECIST v1.1
3. Bone scan progression: the appearance of \>= 2 new lesions (for prostate cancer participants only)
4. Symptomatic progression in an area of radiologically evident disease
* For prostate cancer participants only, serum testosterone \< 50 ng/dL. Participants without prior bilateral orchiectomy are required to remain on Luteinizing hormone-releasing hormone (LHRH) analogue for duration of study. Participants with previously documented denovo primary small cell carcinoma of the prostate are exempt from this criterion. If serum for analysis of testosterone level has been collected but result not available by day of scheduled baseline biopsy, patient may still be eligible for study participation upon at the discretion of the Principal Investigator
* Participants must possess one of the following criteria:
1. Planned treatment within 42 days following baseline tumor biopsy and/or research blood collection with androgen signaling inhibitor excluding enzalutamide (cohort A), immunotherapy (cohort B), radiotherapy (cohort C), investigational therapeutic (cohort D), or agent targeting the DNA repair pathway including but not limited to platinum chemotherapy or poly adenosine diphosphate-ribose polymerase (PARP) inhibition (cohort E). Therapeutic combinations are allowed and as treatment may fall into more than one category, cohort assignment will be per PI discretion.
2. Aggressive variant cancer (cohort F), defined by one or more of the following:
* Presence of one or more visceral organ metastases
* Serum neuron specific enolase and/or chromogranin A \>ULN
* Progression by PCWG2 criteria within 12 months following initiation of primary androgen deprivation therapy (ADT) +/- chemotherapy for metastatic hormone sensitive prostate cancer
* Prior histologic evidence of small cell and/or intermediate atypical carcinoma differentiation
* Presence of advanced or metastatic renal cell carcinoma (Cohort R) with planned treatment with a novel agent such as a targeted agent within 42 days following baseline tumor biopsy. Therapeutic combinations are allowed and as treatment may fall into more than one category, cohort assignment will be per PI discretion
* Presence of advanced or metastatic urothelial carcinoma (Cohort U) with planned treatment with a novel agent such as an Antibody Drug Conjugate (ADC) or a targeted agent within 42 days following baseline tumor biopsy. Therapeutic combinations are allowed and as treatment may fall into more than one category, cohort assignment will be per PI discretion.
* Group 1 (ADT naïve and on ADT \< 3 months): Participants who have not received LHRH analogue, LHRH antagonist or any anti-androgen for metastatic disease. Participants who have received ADT in the past 3 months will be included. Prior use of androgen deprivation therapy in the (neo)adjuvant, salvage, or biochemically recurrent setting is allowed provided the last day of effective androgen deprivation was more than 12 months prior to study entry. Androgen deprivation therapy must be planned to start within 28 days of baseline tumor biopsy.
* Group 2 (ADT Pre-Treated with sub-optimal PSA nadir): Participants who have initiated androgen deprivation therapy (including LHRH agonists, antagonists and/or anti-androgens) for metastatic prostate cancer within 6-12 months prior to study entry who have suboptimal serum PSA nadir \> 0.2 ng/mL.
18 Years
MALE
No
Sponsors
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Prostate Cancer Foundation
OTHER
Strata Oncology
INDUSTRY
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Rahul Aggarwal, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Other Identifiers
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NCI-2018-02052
Identifier Type: REGISTRY
Identifier Source: secondary_id
155518
Identifier Type: -
Identifier Source: org_study_id