Using PSMA PET imaging to guide targeted radiation therapy for high-risk prostate cancer

Is this trial a fit for you?

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

What this trial studies

This clinical trial evaluates the optimal timing of imaging and treatment intervals to maximize the response of prostate-specific membrane antigen (PSMA) PET imaging in patients with high-risk prostate adenocarcinoma. Participants will receive stereotactic ablative radiotherapy (SabR) with an integrated dose boost to the dominant intra-prostatic lesion, alongside androgen deprivation therapy. The study aims to determine the best approach to enhance treatment effectiveness based on PSMA PET imaging results. It involves a sequential cohort evaluation to adapt treatment based on imaging responses.

Why it matters

Who can join: the full rules

Inclusion Criteria:

-Pathologically confirmed adenocarcinoma of the prostate (within 180 days of registration) of high risk by national comprehensive cancer network (NCCN) criteria as determined by \>=cT3a stage (AJCC 8th edition) OR PSA\>20ng/mL OR ISUP Grade Group 4-5 (Gleason Grade 8-10).

Age ≥ 18 years.

* Planned for definitive intent stereotactic ablative radiotherapy (SabR) with integrated dose boost to intra-prostatic tumor and androgen deprivation therapy (ADT) with baseline AUA IPSS \<=18 and prostate size \<=100cc
* Staging 68Ga PMSA-11 PET -CT or -MRI performed within 90 days of registration and before initiation of anti-androgen or androgen deprivation therapy and demonstrating no evidence of distant metastases by (PMSA avid or non-avid nodes \<=1.5cm short axis allowed). Conventional imaging (CT, bone scan, MRI) may also be used in addition to PMSA-PET, and definitive findings of distant extra-pelvic metastases on these scans are not allowed for enrollment.
* Staging 68Ga PSMA-11 PET -CT or -MRI demonstrating a PSMA-avid primary intra-prostatic target lesion amenable at investigator discretion to dose boost
* All men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of standard of care SabR and for a period of time of 6 months thereafter as per standard guidelines. Should a man's partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Prior curative intent local therapy (e.g. prostatectomy, radiotherapy, focal ablative therapy) for prostate cancer is not allowed, with following exceptions regarding androgen deprivation therapy (ADT)/anti-androgen therapy (AAT):

Prior androgen deprivation therapy (ADT) allowed if \<3 month total duration and stopped \>=3 months prior to registration with demonstration of non-castrate testosterone recovery (\>50ng/dL) and meeting all other inclusion criteria.

Ongoing androgen deprivation therapy (ADT) is allowed if \<=60 days total duration AND meeting following criteria:

If GnRH agonist used (e.g. leuprolide), bicalutamide must have been used for at least 30 days +/-14 days from start of GnRH agonist.

All other inclusion criteria.

* Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.
* History of allergic reactions to PMSA-11 68Ga imaging agent.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
* Prior pelvic radiotherapy other than cutaneous/superficial treatments.

Where it's running

• University of Texas Southwestern Medical Center
  Dallas, Texas, United States Recruiting
• UT Southwestern Medical Center
  Dallas, Texas, United States Not yet recruiting

Study contacts

• Principal investigator: Neil Desai, MD MHS — Study Principal Investigator
• Study coordinator: Sarah Neufeld
• Email: Sarah.hardee@utsouthwestern.edu
• Phone: 214-645-8525

Similar studies

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

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

  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.

  Recruiting Phase 2 Mayo Clinic · Rochester, Minnesota · NCT07650240

• Lower-dose radiation to parts of the prostate for some men with prostate cancer

  This study tests whether a smaller amount of radiation aimed at specific parts of the prostate can reduce side effects compared with giving the full prostate the same dose.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07635238

• Next-generation SABR for prostate cancer across Ireland

  This test uses focused high-dose stereotactic radiotherapy (SABR) with urethra-sparing, a rectal spacer, and nerve preservation for men with low-, intermediate-, or selected high-risk prostate cancer to try to control the tumor while reducing side effects.

  Recruiting at 2 sites Phase 2 Cancer Trials Ireland · Dublin, Leinster and 3 other locations · NCT07552168

• Focal HDR-Brachytherapy for Prostate Cancer

  This trial tests using targeted high-dose-rate brachytherapy to treat prostate cancer patients and see if it provides local control with fewer side effects.

  Recruiting Jonsson Comprehensive Cancer Center · Los Angeles, California · NCT07468903

• Shorter androgen deprivation in combination with radiation for high-risk prostate cancer

  Doctors are testing whether 6 months of hormone therapy with radiation works as well as 18 months, for men with high-risk prostate cancer.

  Recruiting Phase 2 University of California, San Diego · La Jolla, California · NCT07364071

• PSMA PET/CT plus MRI to find higher‑grade prostate cancer in men on active surveillance

  This study tries adding rhPSMA-7.3 (flotufolastat F18) PET/CT to standard mpMRI to see if it finds higher-grade prostate cancer in men on active surveillance.

  Recruiting Phase 2 Icahn School of Medicine at Mount Sinai · New York, New York · NCT07285057

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.