Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial (NCT06632977)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. 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.
2. PRE-REGISTRATION: Measurable disease and/or non-measurable metastatic disease per RECIST version 1.1.
3. 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.
4. 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.
5. PRE-REGISTRATION: Age ≥ 18 years.
6. 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):
7. 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.
8. Radiographic progression per RECIST 1.1 criteria for soft tissue lesions
9. Bone metastasis progression per Prostate Cancer Working Group 3 (PCWG3) criteria.
10. 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).
11. 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.
12. 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:

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (108 Sites)

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
• Banner University Medical Center - Tucson — Tucson, Arizona
• University of Arizona Cancer Center-North Campus — Tucson, Arizona
• Enloe Medical Center — Chico, California
• UC San Diego Health System - Encinitas — Encinitas, California
• UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California
• UC San Diego Moores Cancer Center — La Jolla, California
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California
• University of California Davis Comprehensive Cancer Center — Sacramento, California
• UC San Diego Medical Center - Hillcrest — San Diego, California
• UCHealth Memorial Hospital Central — Colorado Springs, Colorado
• Memorial Hospital North — Colorado Springs, Colorado
• Poudre Valley Hospital — Fort Collins, Colorado
• Cancer Care and Hematology-Fort Collins — Fort Collins, Colorado
• UCHealth Greeley Hospital — Greeley, Colorado
• Medical Center of the Rockies — Loveland, Colorado
• Stamford Hospital/Bennett Cancer Center — Stamford, Connecticut
• Beebe South Coastal Health Campus — Millville, Delaware
• Helen F Graham Cancer Center — Newark, Delaware
• Medical Oncology Hematology Consultants PA — Newark, Delaware
• Beebe Health Campus — Rehoboth Beach, Delaware
• Jupiter Medical Center — Jupiter, Florida
• Tripler Army Medical Center — Honolulu, Hawaii
• Kootenai Health - Coeur d'Alene — Coeur d'Alene, Idaho
• Illinois CancerCare-Bloomington — Bloomington, Illinois

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.