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Radioisotope Therapy

177Lu-PSMA-617 in Combination with Niraparib/Abiraterone Acetate plus Prednisone 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

LUNAAR Trial 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.Check my eligibility

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.See study design

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.

LUNAAR Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determination of the recommended phase 2 dose (RP2D)

Prostatic-specific antigen (PSA)-50 response rate

Secondary outcome measures

Duration of response (DOR)

Objective response rate (ORR)

Overall survival (OS)

+2 more

LUNAAR 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

177Lu-PSMA-617

2018

Completed Phase 3

~840

Prednisone

2014

Completed Phase 4

~2370

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rohan GarjeLead Sponsor

1 Previous Clinical Trials

21 Total Patients Enrolled

Janssen Scientific Affairs, LLCIndustry Sponsor

159 Previous Clinical Trials

580,488 Total Patients Enrolled

11 Trials studying Prostate Cancer

1,343 Patients Enrolled for Prostate Cancer

Rohan Garje, M.D.Principal InvestigatorMiami Cancer Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the specific objectives of this research study?

"As per Janssen Scientific Affairs, LLC, the main focus of this study over a 24-month period is to establish the recommended phase 2 dose (RP2D). Additionally, secondary outcomes will be examined including Duration of response (DOR), which tracks the time from meeting complete or partial response criteria until disease progression or recurrence. Soft tissue lesions will follow RECIST 1.1 criteria while bone lesions adhere to PCWG3 standards. Furthermore, Overall survival (OS) measures the duration between treatment initiation and death; participants alive at last contact are noted. Lastly, Objective response rate (ORR) evaluates the percentage of patients"

Answered by AI

Are potential candidates still eligible to participate in this ongoing clinical trial?

"As per information from clinicaltrials.gov, recruitment for this trial is currently closed. The study was first listed on May 1st, 2024 and last updated on March 19th, 2024. While this specific trial is not seeking participants presently, there are a total of 1312 other active studies actively pursuing candidates at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer

Rohan Garje 2024. "177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06329830.

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