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

Starting soon · Phase 2

Conditions studied: High-Risk Localized Prostate Cancer

In brief

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.

Key facts

Study ID

NCT07550517

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

60

Starts

2026-08-01

Expected to finish

2033-08-01

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Platelet count of >100 x109/L
• White blood cell (WBC) count > 3,000/mL
• Neutrophil count of > 1,500/mL
• Hemoglobin ≥ 10 g/dL
• Estimated glomerular filtration rate (eGFR) > 50 mL/min based upon Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation. Due to safety concerns relating to renal clearance and toxicity of 177Lu-PSMA-617, patients with estimated GFR between 50 - 60 mL/min will require a 99mTc-TPA GFR test and only patients with non-obstructive pathology will be included in the study.
• Total bilirubin < 3 x ULN (except if confirmed history of Gilbert's disease)
• Serum albumin > 30 g/L
• Aspartate aminotransferase (AST) < 3 times the ULN
• 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.

You may not qualify if…

• 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.

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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