177Lu-PSMA-617 + Standard Therapy for Prostate Cancer

(PSMAddition Trial)

Recruiting in Palo Alto (17 mi)

+242 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests if adding a radioactive drug to standard hormone treatments can better treat men with advanced prostate cancer. The drug targets and kills cancer cells with radiation, while standard treatments block hormones that help cancer grow.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

Adult men with metastatic hormone-sensitive prostate cancer, who have visible bone or soft tissue/visceral lesions and are either treatment-naive or minimally treated. They must be over 18 years old, have a life expectancy of more than 9 months, good organ function, no severe concurrent conditions, and not be on other clinical trials.

Inclusion Criteria

Patients must have a life expectancy >9 months as determined by the study investigator

Patients must have evidence of PSMA-positive disease as seen on a 68Ga-PSMA-11 PET/CT scan, and eligible as determined by the sponsor's central reader

Patients must have adequate organ function: Bone marrow reserve ANC ≥1.5 x 109/L Platelets ≥100 x 109/L Hemoglobin ≥9 g/dL Hepatic Total bilirubin ≤2 x the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome ≤3 x ULN is permitted Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3.0 x ULN OR ≤5.0 x ULN for patients with liver metastases Renal eGFR ≥ 50 mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) equation Albumin ≥2.5 g/dL Human immunodeficiency virus (HIV)-infected patients who are healthy and have a low risk of acquired immune deficiency syndrome (AIDS)-related outcomes can participate in this trial

Exclusion Criteria

I haven't had specific radiation treatments or PSMA-targeted therapy in the last 6 months.

I agree to use a condom during the study and for 14 weeks after, and not to donate sperm.

I am not currently on any strong cancer treatments like chemotherapy.

Treatment Details

Interventions

• 177Lu-PSMA-617 (Radioisotope Therapy)
• 68Ga-PSMA-11 (Diagnostic Agent)
• ADT (Hormone Therapy)
• ARDT (Hormone Therapy)

Trial Overview The trial is testing the effectiveness and safety of adding a drug called 177Lu-PSMA-617 to the standard prostate cancer treatments (Androgen Receptor Directed Therapy + Androgen Deprivation Therapy) compared to the standard treatments alone in about 1126 patients.

Participant Groups

Group I: 177Lu-PSMA-617 Experimental Treatment 4 Interventions

Participant will receive 7.4 GBq (+/- 10%) 177Lu-PSMA-617, once every 6 weeks (+/- 1 week) for a planned 6 cycles, in addition to the Standard of Care (SOC); ARDT +ADT is considered as SOC and treatment will be administered per the physician's order

Group II: Standard of Care Active Control 3 Interventions

For participants randomized to Standard of Care arm, ARDT +ADT is considered as SOC and treatment will be administered per the physician's order

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Alliance Foundation Trials, LLC.

Collaborator

Trials

25

Recruited

27,200+

RTOG Foundation, Inc.

Collaborator

Trials

7

Recruited

1,500+