PREcision DIagnostics in Prostate Cancer Treatment (PREDICT)
Alliance for Clinical Trials in Oncology
Summary
This phase II trial evaluates whether genetic testing in prostate cancer is helpful in deciding which study treatment patients are assigned. Patient cancer tissue samples are obtained from a previous surgery or biopsy procedure and tested for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) abnormalities or mutations in their cancer. Valemetostat tosylate is in a class of medications called EZH1/EZH2 inhibitors. It blocks proteins called EZH1 and EZH2, which may help slow or stop the spread of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Cabazitaxel injection is in a class of medications called microtubule inhibitors. It works by slowing or stopping the growth of tumor cells. Abiraterone acetate blocks tissues from making androgens (male hormones), such as testosterone. This may cause the death of tumor cells that need androgens to grow. It is a type of anti-androgen. Enzalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Lutetium Lu 177 vipivotide tetraxetan is in a class of medications called radiopharmaceuticals. It works by targeting and delivering radiation directly to tumor cells which damages and kills these cells. Assigning patients to targeted treatment based on genetic testing may help shrink or slow the cancer from growing
Description
The primary and secondary objectives of the study: PRIMARY OBJECTIVE: I. Evaluate objective response rate in patients with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for measurable disease, in each treatment arm. SECONDARY OBJECITVES: I. To determine safety and tolerability as determined by Common Terminology Criteria in Adverse Events (CTCAE) version 5.0 in each treatment arm. II. To evaluate 9-month radiographic progression free survival in each arm as defined by Prostate Cancer Clinical Trials Working Group 3 (PCWG-3) for patients with bone…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * PRE-REGISTRATION: Histological or cytological evidence of prostate cancer. Patients with variant histologies including neuroendocrine, small cell and sarcomatoid prostate cancer are allowed to enroll and these will not be used as selection criteria for individual arms. Central pathology review is not required. * PRE-REGISTRATION: Measurable disease and/or non-measurable metastatic disease per RECIST version 1.1. * PRE-REGISTRATION: Tissue procured within 12 months of pre-registration (metastatic disease preferred over primary tissue, though both are acceptable) available…
Interventions
- OtherGenetic testing
undergo genetic testing
- DrugValemetostat Tosylate
Given PO
- ProcedureMagnetic Resonance Imaging
undergo Magnetic Resonance Imaging
- ProcedureComputed Tomography
undergo Computed Tomography
- ProcedureBone scan
undergo Bone scan
- ProcedureFDG-Positron Emission Tomography
Undergo FDG PET
- ProcedurePSMA PET Scan
Locations (105)
- Banner University Medical Center - TucsonTucson, Arizona
- University of Arizona Cancer Center-North CampusTucson, Arizona
- UC San Diego Health System - EncinitasEncinitas, California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvine, California
- UC San Diego Moores Cancer CenterLa Jolla, California
- UC Irvine Health/Chao Family Comprehensive Cancer CenterOrange, California