Viewing Study NCT06632977



Ignite Creation Date: 2024-10-26 @ 3:42 PM
Last Modification Date: 2024-10-26 @ 3:42 PM
Study NCT ID: NCT06632977
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-10-01

Brief Title: Targeted Treatment for Metastatic Prostate Cancer The PREDICT Trial
Sponsor: None
Organization: None

Study Overview

Official Title: PREcision DIagnostics in Prostate Cancer Treatment PREDICT
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PREDICT
Brief 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 EZH1EZH2 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
Detailed 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 11 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 50 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 metastases and RECIST version 11 for patients with measurable disease

III To evaluate radiographic progression free survival in each arm as defined by PCWG-3 for patients with bone metastases and RECIST version 11 for patients with measurable disease

IV To evaluate prostate-specific antigen PSA response defined as 50 decline in PSA from baseline using PCWG-3 criteria in patients in each treatment arm

V To evaluate time to PSA progression as defined by PCWG-3 criteria in patients in each treatment arm

VI To evaluate time to occurrence of first symptomatic skeletal event VII To evaluate time to first subsequent anti-cancer therapy including androgen receptor signaling agents cytotoxic chemotherapy immunotherapy or investigational agents or death

VIII To evaluate overall survival defined as time from registration to death due to any cause censored at the date of last follow-up in each treatment arm

IX To evaluate patient-reported outcomes PRO via Patient-Reported Outcomes PRO-CTCAE in each treatment arm

X To evaluate duration of response as defined by RECIST version 11 for patients with measurable disease

CORRELATIVE OBJECTIVES

I Correlate presence of molecular abnormalities with baseline clinical characteristics

II Evaluate co-occurring molecular alterations within each biomarker arm III Evaluate mechanisms of response and resistance using available tissue archival or baseline and circulating cell free tumor DNA cfDNA and circulating tumor cells CTCs at baseline on treatment and at progression

IV Evaluate efficacy parameters objective response rate ORR PSA response 9-month radiographic progression-free survival rPFS rPFS based on arm allocation by

IVa DNA versus RNA qualifying molecular alterations IVb Blood versus tissue-based qualifying molecular alteration IVc Primary versus metastasis qualifying molecular alteration

V Evaluate efficacy parameters ORR PSA response 9-month rPFS rPFS based on the following clinical parameters

Va Presence or absence of visceral metastases at baseline Vb Number of prior lines of therapy for metastatic castration resistant cancer mCRPC one versus gt 1 Vc In patients having had prior exposure to taxane chemotherapy Vd Presence or absence of neuroendocrine differentiation at baseline VI Evaluate exceptional responders defined as those with rPFS 18 months and exceptional non-responders

VII To determine how circulating biomarker quantification correlates with clinical features and outcomes

VIII To determine the clinical impact of lineage plasticity alterations in predicting outcomes and response to therapy

EXPLORATORY OBJECTIVE

I To compare patient-assessed adverse events via PRO-CTCAE with clinician-assessed adverse events in each treatment arm

OUTLINE Patients undergo genetic testing on previously-collected tissue samples Patients are then assigned to 1 of 3 arms based on genetic testing results and Molecular Tumor Board MTB decision

ARM A Patients receive valemetostat tosylate orally PO once daily QD on days 1-28 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity

ARM B Patients receive carboplatin intravenously 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

ARM C 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 twice daily 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

All patients also undergo magnetic resonance imaging MRI or computed tomography CT and bone scan throughout the trial Patients may also undergo optional fludeoxyglucose F-18 FDG or prostate-specific membrane antigen PSMA positron emission tomography PET as well as optional blood collection throughout the trial

After completion of study treatment patients without disease progression are followed every 2 months for the first 6 months and then every 3 months after that for up to 5 years Patients with disease progression are followed every 6 months for 5 years

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None