Lu-177-PSMA-617 for Prostate Cancer

Recruiting at 2 trial locations

Overseen By Nitin Yerram, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Hackensack Meridian Health

Must not be taking: Anticoagulants, Nephrotoxic drugs

Disqualifiers: Metastatic disease, Significant comorbidities, 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: 6

Duration: 12 weeks

54 Participants Needed

Trial Summary

What is the purpose of this trial?

Male adults with a confirmed diagnosis of prostate adenocarcinoma who meet criteria for localized high risk prostate cancer according to the NCCN guidelines and who are eligible for prostatectomy will be invited to participate. Criteria for high-risk prostate cancer include patients with preoperative prostate biopsy score of Gleason 8 (GS8) (Grade group 4 \[GG4\]) or higher. Patients also need to have a positive PSMA scan on 68-Ga-PSMA-11 PET/CT scan.

Research Team

Nitin Yerram, MD

Principal Investigator

Hackensack Meridian Health

Eligibility Criteria

This trial is for male adults with high-risk localized prostate cancer, as defined by NCCN guidelines. Participants must have a Gleason score of 8 or higher and a positive PSMA scan. They should be eligible for radical prostatectomy, which is the surgical removal of the prostate gland.

Inclusion Criteria

My prostate cancer is confirmed by a tissue test.

Patients with a life expectancy of greater than 10 years. Life expectancy can be estimated using specific tools and adjusted based on the clinician's assessment of overall health

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

My cancer has spread beyond the local lymph nodes.

My bone marrow does not function properly.

My liver does not work well.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 cycles of Lu-177-PSMA-617 (PluvictoⓇ) administered at 6-week intervals before prostatectomy

12 weeks

2 visits (in-person)

Surgery

Radical prostatectomy with pelvic lymph node dissection is performed

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment and surgery

24 months

Visits at week 3, 6, 9, 11, 12, and every 3 months thereafter

Treatment Details

Interventions

• Lu-177-PSMA-617

Trial Overview The trial is testing Lu-177-PSMA-617, a radiolabeled molecule that targets PSMA-positive cells in patients with high-risk localized prostate cancer before they undergo surgery to remove the prostate.

Participant Groups

Group I: Lu-177-PSMA-617 Treatment Experimental Treatment 1 Intervention

Patients will receive 2 cycles of Lu-177-PSMA-617 (PluvictoⓇ) administered at the dose of 7.4 GBq (±10%), once every 6 weeks (±1 week)

Who Is Running the Clinical Trial?

Hackensack Meridian Health

Lead Sponsor

Trials

141

Recruited

42,900+

Novartis

Industry Sponsor

Trials

1,646

Recruited

2,778,000+

Vasant Narasimhan

Novartis

Chief Executive Officer since 2018

MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government

Shreeram Aradhye

Novartis

Chief Medical Officer since 2022

MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania

Lombardi Comprehensive Cancer Center

Collaborator

Trials

8

Recruited

1,200+