Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Genetic testing — OTHER
  undergo genetic testing
• Valemetostat Tosylate — DRUG
  Given PO
• Magnetic Resonance Imaging — PROCEDURE
  undergo Magnetic Resonance Imaging
• Computed Tomography — PROCEDURE
  undergo Computed Tomography
• Bone scan — PROCEDURE
  undergo Bone scan
• FDG-Positron Emission Tomography — PROCEDURE
  Undergo FDG PET
• PSMA PET Scan — PROCEDURE
  Undergo PSMA PET
• Biospecimen Collection — PROCEDURE
  undergo blood collection
• Carboplatin — DRUG
  Given IV
• Cabazitaxel — DRUG
  Given IV
• Abiraterone Acetate — DRUG
  Given PO
• Enzalutamide — DRUG
  Given PO
• Lutetium Lu 177 Vipivotide Tetraxetan — DRUG
  Given IV

Study Details

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

Key Dates

Start date

Feb 6, 2025

Status verified

Jun 2026

Primary completion

Apr 11, 2030

Completion

Oct 11, 2034

Study Design

Enrollment

474 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (genetic testing, valemetostat tosylate)
  Patients undergo genetic testing on previously-collected tissue samples. Patients receive valemetostat tosylate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT and bone scan throughout the trial. Patients may also undergo optional FDG or PSMA PET, as well as optional blood collection throughout the trial.
• Experimental: Arm B (genetic testing, carboplatin, cabazitaxel)
  Patients undergo genetic testing on previously-collected tissue samples. Patients receive carboplatin IV over 30 minutes and cabazitaxel IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT and bone scan throughout the trial. Patients may also undergo optional FDG or PSMA PET, as well as optional blood collection throughout the trial.
• Experimental: Arm C (genetic testing, physician choice treatment)
  Patients undergo genetic testing on previously-collected tissue. Patients receive one of the following treatment regimens per treating physician: 1)Cabazitaxel IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. 2)Abiraterone acetate PO QD on days 1-28 of each cycle and prednisone PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. 3) Enzalutamide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. 4) Lutetium Lu 177 vipivotide tetraxetan IV on day 1 of each cycle. Treatment repeats every 42 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT and bone scan throughout the trial. Patients may also undergo optional FDG or PSMA PET, as well as optional blood collection throughout the trial.

Primary Outcome Measure

Objective Response [ Time Frame: Within 6 months from the start of treatment ]

Central Contacts

• Rana McKay, MD
  858-822-6185
  [email protected]
• Shiva Baghaie
  [email protected]

Locations (107)

Find similar trials in Birmingham, AL

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