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Double radiation attack: could a Drug-Radiation combo stop prostate cancer spread?

NCT ID NCT05079698

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests whether combining a radioactive drug (177Lu-PSMA-617) with precise radiation therapy (SBRT) is safe for men with hormone-sensitive prostate cancer that has spread to a few other spots in the body. The drug seeks out and attacks cancer cells, while the radiation targets remaining tumors. The main goal is to check for side effects, not yet to measure how well it works. About 29 men will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
177Lu-PSMA-617 (a radioactive drug that targets prostate cancer cells) and stereotactic body radiotherapy (SBRT, a precise type of radiation)
What this could lead to
If this combination proves safe, it could offer a new way to delay cancer spread in men with early metastatic prostate cancer.
What could go wrong
This is a very early (Phase 1) safety study with only 29 participants, so it is not designed to prove effectiveness. The treatment involves radiation and may cause side effects like fatigue or bone marrow suppression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

29 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 or the equivalent KPS conversion value of ≥ 60 . * Patient must have a serum creatinine level \< 1.5 x ULN or EGFR \> 60 mL/min * Patient must have adequate liver laboratory values: * ALT and AST ≤ 2.5 x ULN * Albumin \> 2 g/ dL * Bilirubin \< 3 X ULN * Patient must have normal organ and marrow function as defined as: * Total white blood count \> 3.0 K/mcL * Absolute Neutrophil Count ≥ 1.5 K/mcL * Platelets ≥ 100 K/mcL * Hemoglobin ≥ 9 g/dL * The effects of 177Lu-PSMA-617 and SBRT on the developing human fetus at the recommended therapeutic dose are unknown. Men (including men with vasectomies) must agree to use adequate contraception (a condom and another effective method of birth control) prior to registration, for the duration of study participation, and for at least 3 months thereafter. Men must also agree not to donate sperm for the duration of study participation, and for at least 3 months thereafter. * Patient must be ≥ 18 years of age * Ability to understand, and willingness to sign the informed consent Exclusion Criteria: * 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 * Previously diagnosed active infection (e.g., human immunodeficiency virus \[HIV\] or viral hepatitis) * Any condition that in the opinion of the investigator, would preclude participation in this study * Concurrent corticosteroids and/or adrenal hormone inhibitors, PC-SPES, finasteride, or dutasteride is not allowed. * Receipt of any other investigational agents or participation in a concurrent treatment protocol * Inability to life flat during or tolerate PET CT/MR or SBRT * Patients must not have claustrophobia that would preclude PET/CT imaging or other contraindications to CT imaging * Known allergies, hypersensitivities, or intolerance to Lu-PSMA-617 or its inactive compounding components

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack (Limited Protocol Activities)

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604, United States

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Other studies related to the condition(s) this trial covers.