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PSMA PET Response Guided SabR in High Risk Pca

Recruiting
18 - 99 years of age
Male
Phase 1

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Overview

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

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.

Study details

Prostate Adenocarcinoma

NCT06044857

University of Texas Southwestern Medical Center

20 March 2024

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