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Targeted radiation plus hormone therapy may slow Low-Volume prostate cancer spread

NCT ID NCT07650240

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 1 time

Summary

This phase II trial tests whether adding a targeted radiation drug (177Lu-PSMA-617) to standard hormone therapy, with or without additional hormone-blocking pills, can better control low-volume metastatic hormone-sensitive prostate cancer. The study enrolls men whose cancer has spread to a few sites or returned after initial treatment. Participants receive either hormone therapy alone or combined with the radiation drug and possibly abiraterone and prednisone, with the goal of delaying cancer progression.

What this could mean

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

Active substance
Leuprolide acetate, 177Lu-PSMA-617, abiraterone acetate, prednisone
What this could lead to
If successful, this combination could offer a more effective way to control low-volume metastatic prostate cancer, potentially delaying disease progression and extending time off other treatments.
What could go wrong
This is a phase II trial, so results are preliminary. The added drugs may cause side effects like fatigue, low blood cell counts, or hormonal changes, and the benefit over standard therapy is not yet proven.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 202 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Dec 2030

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: * 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

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

    Contact Email: •••••@•••••

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