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Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial

ConditionsCastration-Resistant Prostate CarcinomaStage IVB Prostate Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlliance for Clinical Trials in Oncology

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 for submission per Section 6.2. For patients who have progressed on A032102 and are pre-registering again, repeat tissue procurement will not be mandated.

PRE-REGISTRATION: Molecular report available performed as part of standard of care testing via any Clinical Laboratory Improvement Act (CLIA)-certified next generation sequencing (NGS) assay. Patients may be assigned based on pre-determined qualifying molecular/DNA alterations as stated in Section 4.8 after receipt of local molecular testing by the A032102 molecular tumor board (MTB). Final determination of arm assignment will be determined by the MTB. For qualifying DNA alteration determined by the MTB, testing may be from tumor tissue collected at any time or circulating tumor DNA (ctDNA) within 12 months of pre-registration. If no qualifying DNA alteration is identified based on the CLIA-certified next generation sequencing assay and MTB review, Caris testing, should be performed for both DNA/RNA profiling. Arm assignment based RNA requires testing of tumor tissue collected within 12 months of pre-registration and MTB review.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Genetic testing

    Other intervention

    undergo genetic testing

  • Valemetostat Tosylate

    Drug

    Given PO

  • Magnetic Resonance Imaging

    Procedure/Surgery

    undergo Magnetic Resonance Imaging

  • Computed Tomography

    Procedure/Surgery

    undergo Computed Tomography

  • Bone scan

    Procedure/Surgery

    undergo Bone scan

  • FDG-Positron Emission Tomography

    Procedure/Surgery

    Undergo FDG PET

  • PSMA PET Scan

    Procedure/Surgery

    Undergo PSMA PET

  • Biospecimen Collection

    Procedure/Surgery

    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

Treatment groups

474 Participants
are divided into 3 treatment groups
Group A: Arm A (genetic testing, valemetostat tosylate)Experimental treatment 8 interventions
Group B: Arm B (genetic testing, carboplatin, cabazitaxel)Experimental treatment 9 interventions
Group C: Arm C (genetic testing, physician choice treatment)Experimental treatment 11 interventions

Trial outcomes

Primary outcomes

1

Objective Response

Objective response is defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Working Group 3 (PCWG3) for patients with measurable disease.

Time frame
Within 6 months from the start of treatment

Secondary outcomes

1

Radiographic Progression Free Survival (rPFS)

Radiographic progression is defined by PCWG-3 for patients with bone metastases and modified RECIST 1.1 criteria for patients with soft tissue metastases. The 9-month radiographic progression-free proportion will be estimated by treatment arm, where patients who withdraw from study after the start of treatment but prior to nine months of follow-up will be counted as failures. rPFS will be calculated from registration date under progression or death by any cause, censoring event-free patients at the date of last disease evaluation. Will be estimated in each treatment arm using the Kaplan-Meier method.

Time frame
From initiation of treatment up to 9 months
2

Overall Survival

Will be calculated from registration date until death due to any cause, censoring event-free patients at the date of last contact. Will be estimated in each treatment arm using the Kaplan-Meier method.

Time frame
Up to 5 years after study registration
3

Duration of Response

Will be estimated according to RECIST v1.1 for patients with measurable disease in each treatment arm using the cumulative incidence function.

Time frame
Up to 5 years after study registration
4

Prostate-specific antigen response

Defined as greater than or equal to 50% decline in PSA from baseline using PCWG-3 criteria. Will be estimated as a proportion in each treatment arm.

Time frame
Through treatment completion, an average of one year

Other outcomes

1

National Cancer Institute PRO-CTCAE™ data

Will evaluate patient scores relative to clinician graded AEs.

Time frame
Up to 5 years after completion of study treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alliance for Clinical Trials in Oncology

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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