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Schedule De-Escalation of 177Lu-PSMA-617 for Metastatic Castrate Resistant Prostate Cancer

This study is looking at a new way to use a treatment called 177Lu-PSMA-617 (lutetium vipivotide tetraxetan) for men with prostate cancer that has spread and is no longer responding to hormone therapy (metastatic castration-resistant prostate cancer). This treatment uses a small molecule that carries a radioactive component to destroy cancer cells. The study wants to see if taking a break from treatment after 5 cycles works as well as the standard 6 continuous cycles. To join, you must have prostate cancer that has spread, is castration-resistant, and shows a certain level of PSMA (prostate-specific membrane antigen) on a special scan. The main goal is to see how long patients live without their cancer getting worse. The study is currently recruiting about 236 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It will compare a treatment pause after 5 cycles of 177Lu-PSMA-617 to the standard 6 continuous cycles.
What's involved
You would undergo blood sample collection, bone scans, and SPECT/CT or PET/CT scans. You would also receive Gallium Ga 68 Gozetotide intravenously and have active monitoring.
Compensation
Not stated in the trial record.
Follow-up
Your progression-free survival will be measured for up to 5 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06200103

Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer

Suspended
PHASE2Ages 18+InterventionalTreatment
Mayo Clinic
~236 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBone ScanClinical ObservationComputed TomographyGallium Ga 68 GozetotideLutetium Lu 177 Vipivotide Tetraxetan

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival
Measured over Up to 5 years

Conditions

Castration-Resistant Prostate Carcinoma
Stage IVB Prostate Cancer AJCC v8

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Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Matthew P. Thorpe, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Scheduled at Mayo Clinic Rochester for therapy with 177Lu PSMA-617
PSMA positive metastatic castration resistant prostate cancer (68Ga and 18F PSMA PET will be considered equivalent for eligibility) , defined by molecular imaging prostate specific membrane antigen (miPSMA) score \>= 2 on Mayo PET report, including interpretation of outside PET or consensus review of PET by nuclear therapy tumor board note in the patient chart
Willingness to provide mandatory blood draws for correlative research. (This requirement is waived for patients enrolling after receiving cycle 1 of 177Lu PSMA-617,and achieving a near complete response on post therapy SPECT, as these patients will not be able to provide a pre-treatment baseline blood sample.)
Provide written informed consent
Ability to complete questionnaire(s) by themselves or with assistance
Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
Lesions with uptake equal to or above liver on cycle 1 post therapy SPECT, demonstrating that a near complete response on follow up post-therapy scan represents response, rather than sensitivity differences between SPECT and pre-treatment PET
Near-complete response on post-therapy SPECT following any of cycles 2-5 of 177Lu PSMA-617. Near-complete response will be defined as no lesions with SUV max above the mean standard uptake value (SUV) of a representative 2cm spherical region of interest in the central right hepatic lobe, as determined by a nuclear medicine trained radiologist
No toxicity that would indicate withholding or reducing dose of the next scheduled cycle of 177Lu PSMA-617 per prescribing information
Hemoglobin (Hgb) ≥ 8 g/dL
Platelets ≥ 75,000/mm\^3
Neutrophils ≥ 100/mm\^3
Estimated glomerular filtration rate (eGFR) \< 50 mL/min \*body surface area (BSA) using Cockcroft-Gault formula OR
Creatinine ≤ 1.5 x upper limit of normal
Aspartate transferase (AST) or alanine transaminase (ALT) ≤ 3 x upper limit of normal
No other unacceptable toxicity in the clinical judgement of the investigators
First progression in patients randomized to pause treatment
PSMA avid lesions on PSMA PET (miPSMA score ≥ 2 following first progression)

Exclusion

Another active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy
Receiving any other investigational agent which would be considered as a treatment for the prostate cancer
Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment
EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment
Uncontrolled intercurrent non-cardiac illness including, but not limited to:
Ongoing or active infection
Psychiatric illness/social situations
Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy
Any other conditions that would limit compliance with study requirements
Any of the following because this study involves: An investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown
Persons able to father a child who are unwilling to employ adequate contraception
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
History of myocardial infarction ≤6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
Serious adverse effect

What this trial measures

  • Progression-free survivalUp to 5 years

    Progression free survival is defined as the time interval between randomization date and the date of disease progression or death, whichever occurs first. Progression will be defined in keeping with Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines. The median progression free survival of each arm, corresponding 95% confidence intervals, and hazard ratio comparing the treatment arm to the control arm will be reported.