177Lu-PSMA-617 vs. ARDT for Prostate Cancer
(PSMAfore Trial)

Recruiting in Palo Alto (17 mi)

+99 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?

The purpose of this study is to determine whether 177Lu-PSMA-617 improves the rPFS or death compared to a change in ARDT in mCRPC participants that were previously treated with an alternate ARDT and not exposed to a taxane-containing regimen in the CRPC or mHSPC settings. Approximately 450 participants will be randomized (225 per treatment group).

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

Adults over 18 with advanced prostate cancer that's resistant to castration and has spread, who've only had one type of hormone therapy (like abiraterone or enzalutamide) but not chemo for this stage. They must have a low testosterone level, be in good physical shape (ECOG 0-1), and show positive signs on a specific PET scan. Major organs need to function well, they can't have severe allergies to trial drugs or certain heart conditions, and should agree to use contraception.

Inclusion Criteria

My prostate cancer is worsening despite treatment.

My cancer has worsened only once after treatment with a specific prostate cancer medication.

My organs are functioning well, including my bone marrow, liver, kidneys, and I have a good level of albumin.

See 11 more

Exclusion Criteria

Concurrent serious medical conditions that may impair study participation or cooperation.

I have had chemotherapy, immunotherapy, or biological therapy for prostate cancer.

I have brain metastases but am not stable, have symptoms, or need steroids for brain function.

See 14 more

Treatment Details

Interventions

177Lu-PSMA-617 (Radioisotope Therapy)
ARDT (Hormone Therapy)

Trial OverviewThe study is testing if the drug 177Lu-PSMA-617 improves survival without cancer progression compared to changing the current hormone therapy in men whose prostate cancer has worsened despite treatment. About 450 participants will be randomly assigned equally into two groups: one receiving the new drug and supportive care; the other getting an alternative hormone therapy plus supportive care.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: 177Lu-PSMA-617Experimental Treatment3 Interventions

Participants will receive 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT may be used.

Group II: Androgen receptor-directed therapy (ARDT)Active Control3 Interventions

For participants randomized to the ARDT arm, the change of ARDT treatment will be administered per the physician's orders. Best supportive care, including ADT may be used.