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Study for High-Risk Localized Prostate Cancer: EBRT/PSMA617/ADT vs. EBRT/ADT

This study is for men with high-risk localized prostate cancer. It compares two treatment approaches. One group receives External Beam Radiation Therapy (EBRT), a shorter course of Androgen Deprivation Therapy (ADT) (6 months), and a drug called 177Lu-PSMA-617. The other group receives EBRT and a longer course of ADT (24 months). Researchers want to see if 177Lu-PSMA-617, combined with EBRT and shorter ADT, is safe and effective, and if it can reduce side effects compared to the standard treatment with longer ADT. You might be eligible if you have high-risk prostate cancer, defined by specific features like a cT3a stage, Grade Group 4 or 5, or a PSA over 20 ng/mL. The main goal is to see how quickly testosterone levels recover after treatment.

Study design
This interventional study plans to enroll 60 men with high-risk localized prostate cancer. It compares two different treatment arms.
What's involved
In one arm, you would receive 177Lu-PSMA-617 intravenously every 6 weeks for up to 4 cycles, with ADT and EBRT. In the other arm, you would receive EBRT and 24 months of ADT.
Compensation
Not stated in the trial record.
Follow-up
Your testosterone recovery will be measured for up to 3 years after randomization.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07550517

PSMA-High: EBRT/ PSMA617/ ADT vs. EBRT/ ADT

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
~60 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:EBRT + 6 mo ADT + 177Lu-PSMA-617EBRT + 24 mo ADT

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of testosterone recovery (TR)
Measured over Post randomization up to 3 years.

Conditions

High-Risk Localized Prostate Cancer

Explore related trials

Prostate CarcinomaFOLH1 Gene

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Ana Kiess · PRINCIPAL_INVESTIGATOR · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Who to contact

Ana Kiess
[email protected]
443-287-7528
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patient must have high-risk prostate cancer (HRPC) defined by presence of exactly one high-risk feature: cT3a OR Grade Group 4 or 5 OR PSA \> 20 ng/mL.
Histologic confirmation of adenocarcinoma of the prostate.
Patient must have localized HRPC defined by conventional imaging (no N1 disease by CT or MRI). Patients with or without intra-pelvic nodal metastases by PSMA-PET may be included as long as not enlarged \>10mm short axis by conventional CT size criteria.
Patients must have PSMA-PET (68Ga-PSMA-11 or 18F-DCFPyL) with prostate tumor SUVmax \> 10.
Patient must qualify for definitive treatment of prostate cancer including EBRT as well as ADT (up to 45 days of prior ADT is allotted).
Patient must be ≥ 18 years of age.
Patient must have a life expectancy ≥ 24 months.
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Adequate bone marrow reserve and organ function as demonstrated by complete blood count and chemistry panel completed within the prior 6 weeks demonstrating:
For male patients with partners of childbearing potential, agreement to use barrier contraceptive method (condom) and to continue its use for 6 months from receiving the last dose of 177Lu-PSMA-617.
Patient must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion

Presence of a very high-risk feature: cT3b to T4 OR primary pattern 5 OR 2 to 3 high-risk features OR \>4 cores with Grade Group 4 or 5.
Any prior pharmacotherapy (with the exception of up to 45 days of ADT prior to randomization), radiation therapy, or surgery as treatment for prostate cancer. Any prior radiopharmaceutical therapy.
Any prior radiation to the pelvis.
Presence of N1 or M1 disease by conventional imaging (CT, MRI, and/or bone scan) or M1 disease by PSMA-PET (68Ga-PSMA-11 or 18F-DCFPyL). Lymph nodes with short axis \> 8 mm by CT will be considered N1 by conventional imaging.
Castration-resistant prostate cancer (CRPC).
Patient receiving any other investigational agents.
Patient is participating in a concurrent treatment protocol involving radiotherapy, surgery, or systemic anti-cancer agents.
Inadequate bone marrow reserve and organ function as detailed in 5.1.10.
Unable to lie flat during or tolerate PET/MRI, PET/CT or EBRT.
Concurrent serious medical condition that, in the opinion of the Investigator, would impair study participation.
Contraindication to receiving pelvic radiation, including history of or active inflammatory bowel disorders.
Refusal to sign informed consent.

What this trial measures

  • Rate of testosterone recovery (TR)Post randomization up to 3 years.

    The rate of testosterone recovery (TR) will be determined by the percentage of patients who recover normal T levels within 3 years after randomization.