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

Phase IB Study of Personalized Ultrahypofractionated Stereotactic Ablative Radiotherapy of High Risk PROstate Cancer Guided by PET PSMA (68Ga PMSA-11; Ilucix) Response (PULSAR ProPhet)

This study tests if using PSMA PET imaging to time radiation therapy better can help improve treatment for people with high-risk prostate cancer.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 99 Years
• Sex: Male
• Sponsor: University of Texas Southwestern Medical Center (other)
• Locations: 2 sites (Dallas, Texas and 1 other locations)
• Trial ID: NCT06044857 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adult males aged 18 and older with pathologically confirmed high-risk prostate adenocarcinoma.

Not a fit: Patients with distant metastases or those not meeting the high-risk criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and personalized treatment for patients with high-risk prostate cancer.

How similar studies have performed: Other studies utilizing PSMA PET imaging for treatment guidance have shown promising results, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Dallas, Texas and 1 other locations

• 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

Conditions: Prostate Adenocarcinoma