Active — Not RecruitingNot Applicable

PROMOTE: Identifying Predictive Markers of Response for Genitourinary Cancer

United States156 participantsStarted 2016-05-25

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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)
✓. Disease progression by RECIST v1.1
✓. Bone scan progression: the appearance of \>= 2 new lesions (for prostate cancer participants only)
✓. Symptomatic progression in an area of radiologically evident disease
✓. 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.
✓. Aggressive variant cancer (cohort F), defined by one or more of the following:

What they're measuring

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

Trial details

NCT IDNCT02735252

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-31

View on ClinicalTrials.gov More Prostate Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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)
✓. Disease progression by RECIST v1.1
✓. Bone scan progression: the appearance of \>= 2 new lesions (for prostate cancer participants only)
✓. Symptomatic progression in an area of radiologically evident disease
✓. 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.
✓. Aggressive variant cancer (cohort F), defined by one or more of the following: