Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial

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

Conditions

• Castration-Resistant Prostate Carcinoma
• Stage IVB Prostate Cancer AJCC v8

Interventions

PROCEDURE

Biospecimen Collection

undergo blood collection

DRUG

Carboplatin

Given IV

DRUG

Cabazitaxel

Given IV

DRUG

Abiraterone Acetate

Given PO

DRUG

Enzalutamide

Given PO

DRUG

Lutetium Lu 177 Vipivotide Tetraxetan

Given IV

OTHER

Genetic testing

undergo genetic testing

DRUG

Valemetostat Tosylate

Given PO

PROCEDURE

Magnetic Resonance Imaging

undergo Magnetic Resonance Imaging

PROCEDURE

Computed Tomography

undergo Computed Tomography

PROCEDURE

Bone scan

undergo Bone scan

PROCEDURE

FDG-Positron Emission Tomography

Undergo FDG PET

PROCEDURE

PSMA PET Scan

Undergo PSMA PET

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Alliance for Clinical Trials in Oncology

  lead OTHER

Principal Investigators

• Rana McKay, MD · Alliance for Clinical Trials in Oncology

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-06

Primary Completion

2030-04-11

Completion

2034-10-11

FDA Drug

Yes

Countries

• United States

Study Locations