Lutetium (177Lu) Vipivotide Tetraxetan + ARPI for Prostate Cancer

(PSMAndARPI Trial)

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Must be taking: ARPI

Must not be taking: Taxane chemotherapy

Disqualifiers: CNS metastases, Cardiac disease, Nephropathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 36 weeks

420 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess whether the combination of AAA617 (administered for 6 cycles at a dose of 7.4 GBq (200 mCi) +/- 10%) and ARPI improves radiographic progression-free survival (rPFS) or time to death compared to AAA617 alone in PSMA-positive mCRPC patients who were previously treated and progressed on ARPI in the biochemical recurrence (BCR)-non metastatic hormone sensitive prostate cancer (mHSPC), mHSPC, or non-metastatic Castration Resistant Prostate Cancer (nmCRPC) setting and have not previously received a taxane-containing regimen in the castrate resistant prostate cancer (CRPC) setting.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

This trial is for men with advanced prostate cancer that has spread and is PSMA-positive. They must have previously progressed on ARPI therapy, not received taxane in the CRPC setting, have low testosterone levels, show disease progression either in soft tissue or bone, and be able to perform daily activities (ECOG 0-2).

Inclusion Criteria

My cancer shows up on a special PET scan that looks for a protein.

My testosterone levels are very low (<50 ng/dL or <1.7 nmol/L).

I have mCRPC and it got worse after treatment with ARPI.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive AAA617 with or without ARPI every 6 weeks for 6 cycles

36 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Regular visits as per study protocol

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

• Abiraterone
• Enzalutamide
• Lutetium (177Lu) Vipivotide Tetraxetan

Trial Overview The study compares a combination of AAA617 plus ARPI against AAA617 alone to see if it can extend the time patients live without their cancer getting worse. Participants will receive AAA617 every cycle for six cycles at a specific dose.

Participant Groups

Group I: Arm A: AAA617 and ARPI Experimental Treatment 3 Interventions

AAA617 and ARPI (Enzalutamide, Abiraterone): * AAA617 will be administered once every 6 weeks (1 cycle) for a planned 6 cycles. * ARPI will be administered from 14 days (+ 7 days) before first dose of AAA617 until participant is no longer clinically benefiting, or experiences unacceptable toxicity or if investigator determines that the patient should discontinue ARPI.

Group II: Arm B: AAA617 alone Active Control 1 Intervention

AAA617 alone: Control Arm B participants will receive a dose of AAA617 which will be administered once every 6 weeks (1 cycle) for a planned 6 cycles.

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