NCT07550517 · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
PSMA-High: EBRT/ PSMA617/ ADT vs. EBRT/ ADT
What this study is about
This research is being done to find out if the study drug, 177Lu-PSMA-617, given before and during the usual treatment External Beam Radiation Therapy (EBRT) treatment, with a shorter course of Androgen Deprivation Therapy (ADT) (6 months) is (1) safe and effective compared to the usual treatment alone, and (2) can reduce the side effects caused by long-term (24 months) ADT in men with high risk localized prostate cancer.
View original scientific description
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.
Interventions
DRUG
EBRT + 6 mo ADT + 177Lu-PSMA-617
In Arm A, 177Lu-PSMA-617 will be given as intravenous infusion every 6 weeks, up to 4 cycles. Cycle 1 Day 1 (C1D1) of 177Lu-PSMA-617 will start at least 2 weeks after ADT, and EBRT will start at least 2 weeks after C1D1.
RADIATION
EBRT + 24 mo ADT
In Arm B, EBRT will start 3-7 weeks after Day 1 of ADT.
Primary outcome measures
Rate of testosterone recovery (TR)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Baltimore, Maryland
Collaborators
Novartis Pharmaceuticals
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 22, 2026 · Source of record for eligibility and locations