PROMOTE: Identifying Predictive Markers of Response for Genitourinary Cancer

Exclusion Criteria

• •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.
• •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.