PSMA PET Response Guided SabR in High Risk Pca

Last updated: March 11, 2025
Sponsor: University of Texas Southwestern Medical Center
Overall Status: Active - Recruiting

Phase

1

Condition

Prostate Cancer

Adenocarcinoma

Treatment

68-Ga PSMA11

Clinical Study ID

NCT06044857
STU-2023-0566
  • Ages 18-99
  • Male

Study Summary

Sequential cohort evaluation of ideal timing of imaging and treatment spacing to discern maximal PSMA (Prostate specific membrane antigen) PET (Positron Emission Tomography) response (PSMA-11 68Ga, Illucix) for adaptation of dominant intra-prostatic lesion tumor boost dose

Eligibility Criteria

Inclusion

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) withintegrated 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 andbefore initiation of anti-androgen or androgen deprivation therapy and demonstratingno evidence of distant metastases by (PMSA avid or non-avid nodes <=1.5cm short axisallowed). Conventional imaging (CT, bone scan, MRI) may also be used in addition toPMSA-PET, and definitive findings of distant extra-pelvic metastases on these scansare not allowed for enrollment.

  • Staging 68Ga PSMA-11 PET -CT or -MRI demonstrating a PSMA-avid primaryintra-prostatic target lesion amenable at investigator discretion to dose boost

  • All men must agree to use adequate contraception (hormonal or barrier method ofbirth control; abstinence) prior to study entry, for the duration of standard ofcare SabR and for a period of time of 6 months thereafter as per standardguidelines. Should a man's partner become pregnant or suspect she is pregnant whileparticipating in this study, she should inform her treating physician immediately.

  • Ability to understand and the willingness to sign a written informed consent.

Exclusion

Exclusion Criteria:

  • Prior curative intent local therapy (e.g. prostatectomy, radiotherapy, focalablative therapy) for prostate cancer is not allowed, with following exceptionsregarding 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 ofthe cancer under study.

  • History of allergic reactions to PMSA-11 68Ga imaging agent.

  • Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that, in the opinion of theinvestigator, would limit compliance with study requirements.

  • Prior pelvic radiotherapy other than cutaneous/superficial treatments.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: 68-Ga PSMA11
Phase: 1
Study Start date:
March 07, 2024
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75239
    United States

    Active - Recruiting

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