Phase
Condition
Prostate Cancer
Adenocarcinoma
Treatment
68-Ga PSMA11
Clinical Study ID
Ages 18-99 Male
Study Summary
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
Connect with a study center
UT Southwestern Medical Center
Dallas, Texas 75390
United StatesSite Not Available
University of Texas Southwestern Medical Center
Dallas, Texas 75239
United StatesActive - Recruiting

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