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Radioisotope Therapy

Combination Therapy for Prostate Cancer (LUNAAR Trial)

Phase 1 & 2

Waitlist Available

Led By Rohan Garje, M.D.

Research Sponsored by Rohan Garje

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the safety and potential side effects of a combination treatment involving Lutetium-177 (177Lu)-PSMA-617, niraparib, and abirater

Who is the study for?

This trial is for individuals with metastatic castration-resistant prostate cancer, which means the cancer has spread and doesn't respond to hormonal therapy. Participants should be suitable for treatment with all study medications.

What is being tested?

The trial tests the safety and effects of combining Lutetium-177 (177Lu)-PSMA-617 with niraparib, abiraterone acetate, and prednisone on survival rates and tumor growth control in varying doses.

What are the potential side effects?

Possible side effects include nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, kidney function changes, and potential allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determination of the recommended phase 2 dose (RP2D)

Prostatic-specific antigen (PSA)-50 response rate

Secondary study objectives

Duration of response (DOR)

Objective response rate (ORR)

Overall survival (OS)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 177Lu-PSMA-617 in Combination with Niraparib/Abiraterone Acetate plus PrednisoneExperimental Treatment3 Interventions

177Lu-PSMA-617 will be administered per standard of care at 7.4 gigabecquerel (GBq) (200 mCi) via intravenous (IV) infusion once every cycle (6 weeks) for 6 cycles. Niraparib/Abiraterone Acetate (Nira/AA) will be taken orally by the participant daily until disease progression or unacceptable toxicity. The starting dose level is 150 mg/1000 mg Nira/AA. Other dose levels include 200 mg/1000 mg, 100 mg/1000 mg, or 50 mg/500 mg Nira/AA once daily. Prednisone (5 mg) will be taken orally by the participant twice daily each day that Nira/AA is taken.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

2014

Completed Phase 4

~2500

177Lu-PSMA-617

2018

Completed Phase 3

~840