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ACTIVE NOT RECRUITING
NCT02735252
NA

PROMOTE: Identifying Predictive Markers of Response for Genitourinary Cancer

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

Summary

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.

Official title: Precision Oncology and Molecular Targeting in Advanced Genitourinary Cancers: Identifying Predictive Markers of Response (The "PROMOTE" Study)

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

156

Start Date

2016-05-25

Completion Date

2027-03-31

Last Updated

2025-11-12

Healthy Volunteers

No

Interventions

OTHER

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.

DEVICE

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

Locations (1)

University of California, San Francisco

San Francisco, California, United States