177Lu-PSMA-617 + Radiation Therapy for Prostate Cancer

AK
RM
Overseen ByRyan Manuel
Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Must be taking: Androgen deprivation therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This research is being done to find out if the study drug, 177Lu-PSMA-617, given before and during standard of care External Beam Radiation Therapy (EBRT) treatment, with a shorter course of Androgen Deprivation Therapy (ADT) (6 months) is (1) safe and effective compared to standard of care alone, and (2) can reduce the side effects caused by long-term (24 months) ADT in men with high risk localized prostate cancer.

Who Is on the Research Team?

AK

Ana Kiess

Principal Investigator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Are You a Good Fit for This Trial?

Inclusion Criteria

I am able to care for myself and do daily activities.
My prostate tumor shows a high PSMA level on a PET scan (SUVmax over 10).
1. Platelet count of \>100 x109/L
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EBRT with either 6 months ADT and 177Lu-PSMA-617 or 24 months ADT

6-24 months

Follow-up

Participants are monitored for safety, efficacy, and quality of life after treatment

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • 177Lu-PSMA-617

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (EBRT + 6 mo ADT + 177Lu-PSMA-617)Experimental Treatment1 Intervention
Group II: Arm B (EBRT + 24 mo ADT)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials
578
Recruited
33,600+

Novartis Pharmaceuticals

Industry Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
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Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

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Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD