A Study of Stereotactic Body Radiotherapy and 177Lu-PSMA-617 for the Treatment of Prostate Cancer

NCT05079698 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 21-158
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 7

Brief Summary

The researchers are doing this study to find out whether giving 177Lu-PSMA-617 followed by a type of radiation therapy called SBRT (stereotactic body radiation therapy) is a safe treatment for your cancer. The study agent has been shown to target tumor cells, and the researchers think that adding 177Lu-PSMA-617 to SBRT may prevent or delay the cancer from continuing to spread.

Conditions

Prostate Cancer

Keywords

Stereotactic Body Radiotherapy; 177Lu-PSMA-617; 21-158

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with dose limiting toxicity (DLT) of fractionated dose of 177Lu-PSMA-617 (Pilot)

  using the National Cancer Institute CTCAE, Version 5

  1 year

Secondary Outcomes (1)

• Proportion of subjects with dose limiting toxicity (DLT) of fractionated dose of 177Lu-PSMA-617 (Phase I)

  1 year

Study Arms (1)

Stereotactic Body Radiotherapy and 177Lu-PSMA-617

EXPERIMENTAL

Drug: 177Lu-PSMA-617; Procedure: Stereotactic Body Radiotherapy (SBRT)

Interventions

177Lu-PSMA-617 DRUG

Intravenous (IV) infusion of 177Lu-PSMA-617 on Day 1 of treatment Cycles 1 and 2. PSMA PET utilizing either the 68Ga-PSMA-11 or 18F-DCFPyL tracer is acceptable. Patients should be restaged using the same tracer which was utilized to establish initial eligibility for the trial.

Stereotactic Body Radiotherapy and 177Lu-PSMA-617

Stereotactic Body Radiotherapy (SBRT) PROCEDURE

No later than 5 weeks (+/- 7 days) after the 2nd cycle of 177Lu-PSMA-617, patients will then undergo SBRT (900 cGy x 3 fractions).

Stereotactic Body Radiotherapy and 177Lu-PSMA-617

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must have a biopsy proven adenocarcinoma of the prostate (biopsy confirmation of the primary tumor or oligometastatic tumor is acceptable)
• The patient's primary tumor must have been previously treated with surgery and/or definitive radiation. Prior salvage treatments (radiation or surgery) to the prostate bed or pelvis is allowed.
• Patients must have a negative multiparametric MRI and/or negative biopsy of the prostate (or prostate bed) even if other imaging modality (including PSMA) was negative for disease in the prostate (or prostate bed) within 2 months of enrollment on study
• °If patient is post-prostatectomy, the MRI Prostate can be excluded at clinician's discretion
• Patients must have had a PSMA scan within 2 months of enrollment on study
• Patient has not received any form of prostate-cancer directed therapy since undergoing screening PSMA scan
• Patient must have 1-5 oligometastatic tumors or lesions of the bone or soft tissue that are detectable on a PSMA PET scan.
• Outside PSMA scans not performed at MSKCC are acceptable but will require official read by MSKCC nuclear medicine for confirmation of metastasis
• Patients with sclerotic, non-PSMA avid osseous lesions which are not felt to reflect active metastatic disease by a radiologist are eligible for the protocol assuming they also have 1-5sites of PSMA avid disease as well as no non-PSMA avid sites which are felt to reflect active metastatic prostate cancer
• All oligometastatic lesions must be amenable to SBRT to a dose of 9 Gy x 3 without exceeding nationally recognized dose limits to adjacent organs at risk as deemed by the treating radiation oncologist
• Patient's insurance is willing to cover SBRT treatment or the patient agrees to cover the costs of this therapy
• Patient must have a prostate specific antigen (PSA) ≥ 0.2 ng/mL but ≤ 50 ng/mL
• Patient may have had prior systemic therapy and/or ADT associated with treatment of their primary prostate cancer. Patient may have had ADT associated with salvage radiation therapy.
• Patients who have been on hormone therapy within 12 months of consent must have testosterone within normal range (221-716 ng/dL at MSKCC) in order to be eligible for treatment on study.
• Baseline testosterone below the normal range for patients who have not had hormone therapy within 12 months of study entry is acceptable

You may not qualify if:

• Pathological findings consistent with small cell and/or neuroendocrine carcinoma of the prostate or any other histology not consistent with prostate adenocarcinoma
• Patients with documented castration resistant prostate cancer (CRPC)
• Patients with a PSMA scan within 2 months of enrollment that do not demonstrate metastatic lesions or demonstrate more than 5 discrete metastatic lesions
• Patients with PSMA negative metastatic lesions or with a mixture of PSMA avid and PSMA negative disease
• Patients with metastatic lesions not amenable to SBRT or treatment of which using a 9 Gy x 3 regimen would result in exceeding nationally accepted or institutional dose limits for nearby organs at risk
• Patients with previous radiation therapy for oligometastatic disease are still eligible
• Patients with prior radiotherapy to \> 25% of the skeleton or prior exposure to prior 223Radium, 89Strontium or 153Samarium containing compounds
• Patients with spinal cord compression, impending spinal cord compression, or parenchymal brain metastases (patients with epidural disease without cord compression are eligible)
• History of a prior or concurrent malignancy whose natural history or treatment has potential to interfere with the safety or efficacy assessments
• Patients with known or suspected history of grade II or higher chronic kidney disease (CKD)
• Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to registration.
• Seizure or known condition that may predispose to seizure (including but not limited to prior stroke, transient ischemic attack, loss of consciousness within 1 year prior to enrollment, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
• Gastrointestinal disorder affecting absorption
• History of viral hepatitis or chronic liver disease with active symptoms
• History of pituitary or adrenal dysfunction

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Pluvicto; Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Brandon Imber, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandon Imber, MD

CONTACT

631-212-6346; imberb@mskcc.org

Michael Morris, MD

CONTACT

646-422-4469

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a single-institutional pilot study of 6 total patients at MSKCC.

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 15, 2021
• Study Start: October 1, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (7)