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Prostate CancerPhase 1NCT05079698

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

A Phase 1 study testing 177Lu-PSMA-617 and Stereotactic Body Radiotherapy (SBRT) in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
177Lu-PSMA-617 and Stereotactic Body Radiotherapy (SBRT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
7 sitesUnited States
Study dates
1 Oct 2021to Oct 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Commack (Limited Protocol Activities)

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553

Other trials in United States

About this study

Official title: A Safety Study of Stereotactic Body Radiotherapy (SBRT) and 177Lu-PSMA617 for the Treatment of Hormone Sensitive, Oligometastatic Prostate Cancer

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
Being tested
177Lu-PSMA-617, Stereotactic Body Radiotherapy (SBRT)
Keywords
Stereotactic Body Radiotherapy, 177Lu-PSMA-617, 21-158
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 177Lu-PSMA-617Drug

    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 (SBRT)Procedure or surgery

    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).

Study groups in NCT05079698
Study groupRoleWhat they receive
Stereotactic Body Radiotherapy and 177Lu-PSMA-617ExperimentalNot described
Receives: Drug: 177Lu-PSMA-617; Procedure: Stereotactic Body Radiotherapy (SBRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 year

Secondary outcomes (1)

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

    National Cancer Institute CTCAE, Version 5 will be used for determining the severity of adverse events.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2021
  2. Study start1 Oct 2021
  3. Primary completionOct 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The study is a single-institutional pilot study of 6 total patients at MSKCC.
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05079698
Sponsor's protocol ID
21-158
Status last verified
Jun 2026
First submitted
4 Oct 2021
Last updated
25 Jun 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 177Lu-PSMA-617 and Stereotactic Body Radiotherapy (SBRT) in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects with dose limiting toxicity (DLT) of fractionated dose of 177Lu-PSMA-617 (Pilot) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05079698.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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