177Lu-PSMA-617 + Radiation Therapy for Prostate Cancer
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?
Ana Kiess
Principal Investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive EBRT with either 6 months ADT and 177Lu-PSMA-617 or 24 months ADT
Follow-up
Participants are monitored for safety, efficacy, and quality of life after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 177Lu-PSMA-617
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive EBRT + 6 mo ADT + 177Lu-PSMA-617
Participants will receive EBRT + 24 mo ADT
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
Novartis Pharmaceuticals
Industry Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD
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