Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up Men only

PSMA-targeted therapy with hormone suppression for low-volume metastatic prostate cancer

Official title: A Phase II Randomized Trial of Intermittent Androgen Deprivation Therapy Alone or Combined With [177Lu]Lu-PSMA-617, With or Without Abiraterone and Prednisone, in Patients With Low-Volume Metastatic Hormone-Sensitive Prostate Cancer

Run by Mayo Clinic · NCT07650240 · Data updated 2026-11-12

This phase II trial tests leuprolide acetate alone versus with 177Lu-PSMA-617 (with or without abiraterone acetate and prednisone) in men with hormone-sensitive, low-volume metastatic prostate cancer.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment202 (estimated)
SponsorMayo Clinic
Academic / other
Drugs / interventionschemotherapy, radiation, prednisone
Locations1 site (Rochester, Minnesota)
StatusRecruiting
StartedAugust 4, 2026
Main results expectedDecember 30, 2030
Study endsDecember 30, 2030
Registry record updatedSeptember 18, 2026
Trial IDNCT07650240 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men 18 years or older with histologically confirmed prostate adenocarcinoma and de novo or recurrent low-volume metastasis who have received prior local therapy and are eligible for androgen deprivation therapy.

Probably not a fit

Patients with higher-volume disease, rapid progression on prior therapies, or significant comorbidity may derive little or no benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase II interventional study evaluating two strategies: androgen deprivation therapy alone and androgen deprivation therapy combined with a PSMA-targeted radioligand, with optional abiraterone and prednisone. Participants must have hormone-sensitive, low-volume metastatic prostate cancer and prior local treatment. The trial uses PSMA PET imaging to identify eligible patients and compares outcomes across treatment arms. Primary aims include safety and preliminary efficacy signals, with standard-of-care therapies as background. Lead sponsor is Mayo Clinic and the study is conducted at Mayo Clinic in Rochester, MN.

Why it matters

Potential benefit: If successful, the approach could improve control of hormone-sensitive, low-volume metastatic prostate cancer and potentially delay progression.

How similar studies have gone: Prior studies with PSMA-targeted radioligand therapy have shown activity in metastatic prostate cancer, but this specific combination in low-volume, hormone-sensitive disease is exploratory.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Male patients aged 18 years or older
* Signed informed consent must be obtained prior to participation in the study
* Histologically confirmed adenocarcinoma of the prostate
* Prior treatment with radical prostatectomy or radiation therapy for localized disease is required
* Prior treatment with ADT or androgen receptor pathway inhibitor (ARPI) or cytotoxic chemotherapy is permitted if:

  * The last treatment \> 12 months from enrollment on the trial
  * The duration of treatment is less than 3 months and no evidence of disease progression on treatment
* Disease detected on PSMA PET/CT scan \[PSMA-avid low volume metastasis (LVM)\]. Patients with standardized uptake value maximum (SUVMax) lesion/liver \>1 \[molecular imaging PSMA (miPSMA) score of 2\] or lesion/parotid \> 1 (miPSMA score of 3) would be included. PET scanners used in the study will comply with current guidelines established by the European Association of Nuclear Medicine (EANM) Research Limited (Ltd) (EARL) for harmonizing PET/CT image acquisition and reconstruction
* Patients with hormone sensitive low volume metastatic disease (LVM); either de novo metastatic or recurrent disease. LVM, as assessed on PSMA PET/CT is defined as:

  * =\< 10 total metastatic spots

    * Lymph nodes with short axis of =\< 2.5 cm
    * Total tumor volume (TTV) \< 200 mL
  * =\< 4 bone metastases
  * No brain or liver metastases
* Eastern Cooperative Oncology Group (ECOG) performance 0 - 2
* Hemoglobin \>= 9 g/dL
* Platelet count \>= 100,000/mm\^3
* Absolute neutrophil count \>= 1,500/mm\^3
* Serum bilirubin =\< 1.5 x upper limit of normal (ULN)
* Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =\< 2.5 x ULN
* Serum creatinine =\< 1.5 x ULN or an estimated glomerular filtration rate (eGFR) \>= 50 mL/min/1.73m\^2
* Able to start therapy within 28 days of screening
* Expected life expectancy \> 6 months

Exclusion Criteria:

* PSMA-undetectable disease defined as rising prostate specific antigen (PSA) with absence of PSMA-positive lesions in PSMA PET/CT imaging
* PSMA-negative disease defined as lesions detected on imaging that are deemed concerning for active cancer metastasis with PSMA SUVmax less than liver and meeting specific size criteria: lymph nodes with short axis of \>= 2.5 cm, visceral lesions with a solid appearance (soft tissue density) \>= 1 cm, and bone metastases with a measurable soft tissue component \>= 1 cm
* Patient with in-field failure (disease recurrence in prostate bed after primary definitive prostatectomy or radiotherapy)
* Patient with spinal metastatic disease-causing cord compression
* Patient with prior disease progression on ADT \[castration resistance prostate cancer (CRPC)\]
* Prior treatment with ADT or cytotoxic chemotherapy or ARPI within less than 12 months from enrollment on the trial
* Prior treatment with ADT or ARPI or cytotoxic chemotherapy is permitted only if more than 3 months treatment duration and no evidence of disease progression on treatment
* Patients with severe \[Common Terminology Criteria for Adverse Events (CTCAE) grade \> 2\] xerostomia
* Patients with well documented history of myelosuppression or renal disease that might impair their participation in the trial per medical advice
* Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated non-melanoma skin cancer, superficial bladder cancer are eligible
* Estimated life expectancy \< 6 months
* Concurrent serious medical co-morbidities as determined by study investigator and expected to impair participation in the study

  * Subjects with female partners of reproductive potential are required to use effective, medically acceptable methods of birth control (e.g., spermicide in conjunction with a barrier such as a condom or sexual abstinence) while on this study, and for 14 weeks after the last dose of 177Lu-PSMA-617

Where it's running

  • Mayo Clinic in Rochester
    Rochester, Minnesota, United States
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.