Clinical trial Recruiting at 1 site Observational Ages 18 and up Men only

SPECT/CT imaging to measure radiation dose during Pluvicto (177Lu‑PSMA‑617) treatment

Official title: SPECT/CT Imaging for Dosimetry in 177Lu-PSMA-617 (Pluvicto) Therapy

Run by University of Michigan Rogel Cancer Center · NCT07096999 · Data updated 2026-11-12

This project will use SPECT/CT scans to see if measured radiation doses to tumors and normal organs predict response and side effects in men with metastatic castration‑resistant prostate cancer receiving 177Lu‑PSMA‑617 (Pluvicto).

More Castration-resistant Prostate Cancer trials

Quick facts

Study typeObservational
Ages18 Years and up
SexMen only
Enrollment60 (estimated)
SponsorUniversity of Michigan Rogel Cancer Center
Academic / other
Locations1 site (Ann Arbor, Michigan)
StatusRecruiting
StartedJanuary 23, 2025
Main results expectedJanuary 23, 2031
Study endsJanuary 23, 2031
Registry record updatedJuly 27, 2026
Trial IDNCT07096999 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Men aged 18 or older with metastatic castration‑resistant prostate cancer who are clinically stable and scheduled to receive 177Lu‑PSMA‑617 and can give informed consent are ideal candidates.

Probably not a fit

Patients who are not receiving 177Lu‑PSMA‑617, have tumors that are not PSMA‑targetable, or cannot tolerate the imaging protocol (for example cannot lie flat) are unlikely to benefit from participation.

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 non‑interventional imaging study enrolling men who are scheduled to receive 177Lu‑PSMA‑617 therapy. Participants will undergo SPECT/CT imaging according to a dosimetry imaging protocol so absorbed radiation dose to tumors and normal organs can be calculated. Those dose estimates will be compared with clinical response measures and with observed organ toxicities to look for dose‑response and dose‑toxicity relationships. The study aims to inform personalized dosing and safety monitoring for future patients receiving this radioligand therapy.

Why it matters

Potential benefit: If successful, the study could help personalize Pluvicto dosing to improve tumor control while reducing side effects for future patients.

How similar studies have gone: Prior dosimetry work with radioligand therapies has suggested dose‑response and dose‑toxicity relationships, but definitive, widely adopted dose thresholds for 177Lu‑PSMA‑617 have not yet been established.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* \* 177Lu-617 PSMA treatment scheduled for mCRPC

  * Clinically stable as determined by the nuclear medicine clinicians
  * Male
  * ≥ 18 years of age
  * Willing and able to provide informed consent

Exclusion Criteria:

* Patients who are unable to lie flat on the imaging systems long enough to permit imaging protocols to be performed

Where it's running

  • University of Michigan Comprehensive Cancer Center
    Ann Arbor, Michigan, United States
    Recruiting

Study contacts

  • Principal investigator: Yuni K Dewaraja — University of Michigan Rogel Cancer Center

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Testing Different Dosing Schedules of Lutetium-177Lu PSMA RLT in Advanced Prostate Cancer

    This trial tests if spacing out Lutetium-177Lu PSMA RLT doses adapts to the patient and improves quality of life without shortening life in men with advanced, hormone-resistant prostate cancer.

    Recruiting at 105 sites Phase 3 Alliance for Clinical Trials in Oncology · Anchorage, Alaska and 141 other locations · NCT07200830

  • New ACK1-blocking pill (R)-9bMS for advanced prostate cancer

    This phase 1 trial will test whether the oral ACK1 inhibitor (R)-9bMS is safe and tolerable in men with metastatic castration-resistant prostate cancer who no longer respond to enzalutamide or abiraterone.

    Recruiting Phase 1 TechnoGenesys, Inc. · Madison, Wisconsin · NCT06705686

  • Intensified treatment for advanced prostate cancer using 177Lu-PSMA-617

    This study is testing a new treatment called 177Lu-PSMA-617 for men with advanced prostate cancer that doesn't respond to hormone therapy to see if it works better than the usual treatments.

    Recruiting at 2 sites Phase 2 University of Washington · San Francisco, California and 2 other locations · NCT06526299

  • Cell therapy combined with enzalutamide for advanced prostate cancer

    This study is testing a new combination of cell therapy and a medication called enzalutamide to see if it helps people with advanced prostate cancer live better and longer.

    Recruiting Phase 1/2 Fred Hutchinson Cancer Center · Seattle, Washington · NCT06236139

  • Using a new imaging test for prostate cancer before treatment

    This study is testing a new imaging scan to see how well it can show the spread of advanced prostate cancer before starting treatment.

    Recruiting at 2 sites Phase 4 Brigham and Women's Hospital · Boston, Massachusetts and 1 other locations · NCT06099093

  • Using abemaciclib before a radioactive treatment for advanced prostate cancer

    This study is testing if taking abemaciclib before a radioactive treatment can help men with advanced prostate cancer feel better and improve their treatment results.

    Recruiting Phase 1/2 University of California, San Francisco · San Francisco, California · NCT05113537

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.