Übersicht

Eignung

Details zum Design

Arme & Interventionen

Ergebnismessungen

Studienzentren

Quelle: NCT06632977

Rekrutierung

PREDICT: Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial

Interventionsstudie

Phase 2

University of Oklahoma Health Sciences Center

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

Detaillierte Beschreibung anzeigen

Behandlungskategorie

Andere, Zielgerichtete Therapie, Eingriff, Radiopharmazeutika, Chemotherapie, Hormontherapie, Andere Medikamente

Erforderliche Mutationen

BRCA2, BRCA1

Studie gestartet

2025-02-06

Zuletzt vom Sponsor aktualisiert

2025-12-09

Voraussichtlicher Abschluss

2030-04-11

Eignung

Einschlusskriterien

* 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.

* PRE-REGISTRATION: Age ≥ 18 years.

* REGISTRATION: Progressive mCRPC as defined: 1) castrate levels of serum testosterone < 50 ng/dL AND one or more of the following criteria (choose all the apply):

* PSA progression, defined by at least 2 consecutive rising PSA values at a minimum of 1-week intervals with the most recent PSA value being 2.0 ng/mL or higher, if confirmed PSA rise is the only indication of progression. Patients who received an anti-androgen must have PSA progression after withdrawal of anti-androgen therapy.

* Radiographic progression per RECIST 1.1 criteria for soft tissue lesions

* Bone metastasis progression per Prostate Cancer Working Group 3 (PCWG3) criteria.

* REGISTRATION: Patients selected to receive lutetium Lu 177 vipivotide tetraxetan treatment are required to have prostate-specific membrane antigen (PSMA) positive mCRPC as determined by investigator assessment. For reference, in the VISION trial this was defined as at least 1 PSMA+ metastatic lesion (defined as uptake greater than that of liver parenchyma in lesions of any size in any organ system) and no PSMA- lesions (defined as uptake equal to or lower than that of liver parenchyma in any lymph node with a short axis of at least 2.5 cm, in any solid organ lesion with a short axis of at least 1.0 cm, or in any bone lesion with a soft-tissue component of at least 1.0 cm in the short axis).

* REGISTRATION: Prior treatment with androgen receptor signaling inhibitor (ARSI) in either the metastatic hormone sensitive setting or mCRPC is required. Prior taxane therapy in either metastatic hormone sensitive setting or mCRPC is mandated unless patient is taxane ineligible or the patient refuses taxane therapy. Prior lutetium LU177 vipivotide tetraxetan treatment is permitted but not mandated. Patients with known germline or somatic deleterious BRCA 1/2 mutations must have received a prior PARPi.

* REGISTRATION: Resolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable grade 2 toxicities (defined as no worsening to > grade 2 for at least 3 months prior to registration and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, comprised of:

* Chemotherapy-induced neuropathy

* Fatigue

* Residual toxicities from prior treatment: Grade 1 or grade 2 endocrinopathies which may include: Hypothyroidism/hyperthyroidism. type I diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation (vitiligo)

* REGISTRATION: No cytotoxic, biologic, radiopharmaceutical or other non-kinase inhibitor investigational agent within 4 weeks of registration. Treatment with any type of small molecular kinase inhibitor (including investigational kinase inhibitor) within 2 weeks of registration. Treatment with abiraterone acetate, apalutamide, or darolutamide within 2 weeks of registration. Treatment with enzalutamide within 4 weeks of registration. No treatment with radiation therapy within 2 weeks of registration.

* REGISTRATION: No major surgery within 4 weeks of registration.

* REGISTRATION: No prior treatment with EZH inhibitors.

* REGISTRATION: Prior treatment with cabazitaxel + carboplatin.

* REGISTRATION: None of the following conditions:

* Current use of moderate or strong cytochrome P450 (CYP)3A inducers.

* Known or suspected hypersensitivity to valemetostat tosylate (DS-3201b) or any of the excipients.

* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.

* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.

* Imminent or established spinal cord compression based on clinical and/or imaging findings.

* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to registration after radiotherapy or at least 4 weeks prior to registration after major surgery (e.g., removal or biopsy of brain metastasis). Patients must have complete wound healing from major surgery or minor surgery before registration.

* Significant cardiovascular defined as:

* Myocardial infarction within 6 months prior to enrollment.

* Uncontrolled angina pectoris within 6 months prior to enrollment.

* New York Heart Association Class 3 or 4 congestive heart failure.

* Corrected QT interval calculated by the Fridericia's formula (QTcF) ≥ 470 ms per electrocardiogram (ECG) within 42 days before randomization in any individual with any history of any cardiac disease or medication which can impact QTcF. Patients with known history or current symptoms of cardiac disease, history of treatment with cardiotoxic agents, or agents/conditions known to impact QTcF should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and ECG.

* Uncontrolled hypertension (resting systolic blood pressure >160 mmHg or diastolic blood pressure > 100 mmHg).

* Clinically significant acute infection requiring systemic antibacterial, antifungal or antiviral therapy.

* Moderate to severe hepatic impairment (Child-Pugh Class C)

* REGISTRATION: No freezing or donating sperm ≤ 14 days prior to registration.

* REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

* REGISTRATION: No granulocyte colony-stimulating factor (GCSF) within 2 weeks of registration.

* REGISTRATION: No red blood cell (RBC) transfusions within 2 weeks of registration.

* REGISTRATION: No platelet transfusions within 2 weeks of registration.

* REGISTRATION: No bleeding diathesis.

* REGISTRATION: White blood cell count (WBC) ≥ 2,500/mcL.

* REGISTRATION: Absolute neutrophil count (ANC) ≥ 1,500/mcL.

* REGISTRATION: Hemoglobin ≥ 9 g/dL.

* REGISTRATION: Platelet count ≥ 100,000/mcL.

* REGISTRATION: Creatinine clearance ≥ 30 mL/min as defined by Cockcroft-Gault equation.

* REGISTRATION: Total bilirubin ≤ 1.5 x ULN (≤ 3 x upper limit of normal [ULN] for subjects with documented Gilbert's disease).

* REGISTRATION: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN.

* REGISTRATION: Albumin ≥ 2.8 g/dL.

* REGISTRATION: The A032102 molecular tumor board will review the local pathology report and molecular sequencing report, and the Alliance registration/randomization office will relay the assignment to the submitting site. Once the site receives this assignment, they can register the patient to A032102. Any questions about the molecular board treatment assignments can be directed to A032102@alliancenctn.org.

* RE-REGISTRATION: Progressive mCRPC (after receiving the tumor board assigned therapy) as defined: 1) castrate levels of serum testosterone < 50 ng/dL AND 2) progressive disease defined by radiographic progression on conventional imaging (CT/MRI chest, abdomen and pelvis and bone scan within 42 days of re-registration).

* RE-REGISTRATION: Resolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) resolved to CTCAE version 5.0, grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable grade 2 toxicities (defined as no worsening to > grade 2 for at least 3 months prior to registration and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, comprised of:

* Chemotherapy-induced neuropathy

* Fatigue

* RE-REGISTRATION: None of the following conditions:

* Imminent or established spinal cord compression based on clinical and/or imaging findings.

* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to registration after radiotherapy or at least 4 weeks prior to re-registration after major surgery (e.g., removal or biopsy of brain metastasis). Patients must have complete wound healing from major surgery or minor surgery before re-registration.

* Corrected QT interval calculated by the Fridericia's formula (QTcF) < 470 ms per ECG within 42 days before randomization in any individual with any history of any cardiac disease or medication which can impact QTcF.

* Significant cardiovascular defined as:

* Myocardial infarction within 6 months prior to enrollment.

* Uncontrolled angina pectoris within 6 months prior to enrollment.

* New York Heart Association Class 3 or 4 congestive heart failure.

* Uncontrolled hypertension (resting systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg).

* RE-REGISTRATION: ECOG Performance Status 0-2.

* RE-REGISTRATION: No GCSF within 2 weeks of registration.

* RE-REGISTRATION: No RBC transfusions within 2 weeks of registration.

* RE-REGISTRATION: No platelet transfusions within 2 weeks of registration.

* RE-REGISTRATION: WBC ≥ 2,500/mcL.

* RE-REGISTRATION: ANC ≥ 1,500/mcL.

* RE-REGISTRATION: Hemoglobin ≥ 9 g/dL (transfusions permitted).

* RE-REGISTRATION: Platelet count ≥ 100,000/mcL.

* RE-REGISTRATION: Creatinine clearance ≥ 30 mL/min as defined by Cockcroft-Gault equation.

* RE-REGISTRATION: Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for subjects with documented Gilbert's disease).

* RE-REGISTRATION: AST and ALT ≤ 3 x ULN.

* RE-REGISTRATION: Albumin ≥ 2.8 g/dL.

* RE-REGISTRATION: QT Interval (QTcF) < 470 ms (in individuals with any cardiac history of any medication or condition known to impact QTcF).

* RE-REGISTRATION: The A032102 molecular tumor board will review the CARIS molecular sequencing report, the Alliance registration/randomization office will relay the assignment to the site. Any questions about the molecular board treatment assignments can be directed to A032102@alliancenctn.org.

Ausschlusskriterien

Keine

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Design-Details

ZuteilungNon-Randomized

InterventionsmodellParallel Assignment

MaskierungNone (Open Label)

Anzahl der Teilnehmer474

Arme & Interventionen

Arme

Interventionen

Typ: Experimental

Beschreibung: 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.

Interventionen:

Genetic testing
Valemetostat Tosylate
Magnetic Resonance Imaging
Computed Tomography
Bone scan
FDG-Positron Emission Tomography
PSMA PET Scan
Biospecimen Collection
Carboplatin
Cabazitaxel
Abiraterone Acetate
Enzalutamide
Lutetium Lu 177 Vipivotide Tetraxetan

Ergebnismessungen

Primäre Ergebnismessungen

Objective ResponseWithin 6 months from the start of treatment

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.

Sekundäre Ergebnismessungen

Radiographic Progression Free Survival (rPFS)From initiation of treatment up to 9 months

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.

Overall SurvivalUp to 5 years after study registration

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.

Duration of ResponseUp to 5 years after study registration

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

Prostate-specific antigen responseThrough treatment completion, an average of one year

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 to systematic skeletal eventsUp to 5 years after registration

A skeletal related event is defined as the use of external beam radiotherapy to relieve skeletal symptoms or the occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral) or the occurrence of spinal cord compression or a tumor related orthopedic surgical intervention. Will be estimated in each treatment arm using the cumulative incidence function.

Time to subsequent anti-cancer therapyUp to 5 years after registration

Defined as time from registration to first subsequent anti-cancer therapy or death, censoring event-free patients at date of last follow-up. Will be estimated in each treatment arm using the cumulative incidence function.

Rate of Grade 3+ AEsUp to 6 months after completion of study treatment

Will be collected and graded according ot the NCI CTCAE v5.0 criteria and per PRO-CTCAE.

National Cancer Institute PRO-CTCAE™ dataUp to 5 years after completion of study treatment

Will evaluate patient scores relative to clinician graded AEs.

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Studienzentren

Diese Studie hat 73 Studienzentren

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, US

Rekrutierend

Oklahoma City, Oklahoma, 73104 US

University of Oklahoma Health Sciences Center

Rekrutierend

Milwaukee, Wisconsin, 53226 US

Medical College of Wisconsin

Rekrutierend

Tucson, Arizona, 85719 US

Banner University Medical Center - Tucson

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Orange, California, 92868 US

UC Irvine Health/Chao Family Comprehensive Cancer Center

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Sacramento, California, 95817 US

University of California Davis Comprehensive Cancer Center

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Iowa City, Iowa, 52242 US

University of Iowa/Holden Comprehensive Cancer Center

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Boston, Massachusetts, 02215 US

Dana-Farber Cancer Institute

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Hackensack, New Jersey, 07601 US

Hackensack University Medical Center

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Buffalo, New York, 14263 US

Roswell Park Cancer Institute

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Chapel Hill, North Carolina, 27599 US

UNC Lineberger Comprehensive Cancer Center

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Portland, Oregon, 97213 US

Providence Portland Medical Center

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Fort Collins, Colorado, 80524 US

Poudre Valley Hospital

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Springfield, Massachusetts, 01199 US

Baystate Medical Center

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Cleveland, Ohio, 44109 US

MetroHealth Medical Center

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Jupiter, Florida, 33458 US

Jupiter Medical Center

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Portland, Oregon, 97225 US

Providence Saint Vincent Medical Center

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Sayre, Pennsylvania, 18840 US

Guthrie Medical Group PC-Robert Packer Hospital

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Dallas, Texas, 75390 US

UT Southwestern/Simmons Cancer Center-Dallas

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Huntington, West Virginia, 25701 US

Edwards Comprehensive Cancer Center

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Kansas City, Kansas, 66160 US

University of Kansas Cancer Center

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Tucson, Arizona, 85719 US

University of Arizona Cancer Center-North Campus

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Eureka, Illinois, 61530 US

Illinois CancerCare-Eureka

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Ottawa, Illinois, 61350 US

Illinois CancerCare-Ottawa Clinic

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Peru, Illinois, 61354 US

Illinois CancerCare-Peru

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Portland, Oregon, 97239 US

Oregon Health and Science University

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La Jolla, California, 92093 US

UC San Diego Moores Cancer Center

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Colorado Springs, Colorado, 80909 US

UCHealth Memorial Hospital Central

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Bloomington, Illinois, 61704 US

Illinois CancerCare-Bloomington

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Bettendorf, Iowa, 52722 US

University of Iowa Healthcare Cancer Services Quad Cities

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Billings, Montana, 59101 US

Billings Clinic Cancer Center

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Edmonds, Washington, 98026 US

Swedish Cancer Institute-Edmonds

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Newark, Delaware, 19713 US

Helen F Graham Cancer Center

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Newark, Delaware, 19713 US

Medical Oncology Hematology Consultants PA

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Rehoboth Beach, Delaware, 19971 US

Beebe Health Campus

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Milford, Massachusetts, 01757 US

Dana-Farber/Brigham and Women's Cancer Center at Milford Regional

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Richmond, Virginia, 23235 US

VCU Massey Cancer Center at Stony Point

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South Weymouth, Massachusetts, 02190 US

Dana-Farber/Brigham and Women's Cancer Center at South Shore

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San Diego, California, 92103 US

UC San Diego Medical Center - Hillcrest

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Westwood, Kansas, 66205 US

University of Kansas Hospital-Westwood Cancer Center

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Midlothian, Virginia, 23114 US

Bon Secours Saint Francis Medical Center

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Richmond, Virginia, 23226 US

Bon Secours Saint Mary's Hospital

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Colorado Springs, Colorado, 80920 US

Memorial Hospital North

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Fort Worth, Texas, 76104 US

UT Southwestern/Simmons Cancer Center-Fort Worth

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Mechanicsville, Virginia, 23116 US

Bon Secours Memorial Regional Medical Center

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Overland Park, Kansas, 66211 US

University of Kansas Hospital-Indian Creek Campus

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Richardson, Texas, 75080 US

UT Southwestern Clinical Center at Richardson/Plano

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Richmond, Virginia, 23230 US

Bon Secours Cancer Institute at Reynolds Crossing

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Fort Collins, Colorado, 80528 US

Cancer Care and Hematology-Fort Collins

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Greeley, Colorado, 80631 US

UCHealth Greeley Hospital

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Loveland, Colorado, 80538 US

Medical Center of the Rockies

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O'Fallon, Illinois, 62269 US

Cancer Care Center of O'Fallon

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Topeka, Kansas, 66606 US

University of Kansas Health System Saint Francis Campus

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Menomonee Falls, Wisconsin, 53051 US

Froedtert Menomonee Falls Hospital

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West Bend, Wisconsin, 53095 US

Froedtert West Bend Hospital/Kraemer Cancer Center

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Methuen, Massachusetts, 01844 US

Dana Farber-Merrimack Valley

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Oak Creek, Wisconsin, 53154 US

Drexel Town Square Health Center

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Brighton, Michigan, 48114 US

Trinity Health IHA Medical Group Hematology Oncology - Brighton

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Canton, Michigan, 48188 US

Trinity Health IHA Medical Group Hematology Oncology - Canton

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Chelsea, Michigan, 48118 US

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

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Livonia, Michigan, 48154 US

Trinity Health Saint Mary Mercy Livonia Hospital

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Ypsilanti, Michigan, 48197 US

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

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Edgewood, Kentucky, 41017 US

Saint Elizabeth Healthcare Edgewood

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Encinitas, California, 92024 US

UC San Diego Health System - Encinitas

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Dallas, Texas, 75237 US

UT Southwestern Simmons Cancer Center - RedBird

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Richmond, Virginia, 23223 US

Bon Secours Richmond Community Hospital

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Ames, Iowa, 50010 US

McFarland Clinic - Ames

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Lansing, Michigan, 48912 US

University of Michigan Health - Sparrow Lansing

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Richmond, Virginia, 23298 US

VCU Massey Comprehensive Cancer Center

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Fort Thomas, Kentucky, 41075 US

Saint Elizabeth Healthcare Fort Thomas

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Irvine, California, 92612 US

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

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Millville, Delaware, 19967 US

Beebe South Coastal Health Campus

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Foxborough, Massachusetts, 02035 US

Dana-Farber Cancer Institute at Foxborough

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Olathe, Kansas, 66061 US

The University of Kansas Cancer Center - Olathe

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