Actively Recruiting
PSMA PET Response Guided SabR in High Risk Pca
Led by University of Texas Southwestern Medical Center · Updated on 2026-04-14
20
Participants Needed
2
Research Sites
138 weeks
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
O
Once Upon a Time Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
PSMA PET Response Guided SabR in High Risk Pca
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed adenocarcinoma of the prostate within 180 days of registration, classified as high risk by NCCN criteria (≥cT3a stage, PSA >20 ng/mL, or ISUP Grade Group 4-5 [Gleason Grade 8-10])
- Age 18 years or older
- Planned for definitive stereotactic ablative radiotherapy with integrated dose boost to intra-prostatic tumor and androgen deprivation therapy
- Baseline American Urological Association (AUA) International Prostate Symptom Score (IPSS) of 18 or less
- Prostate size of 100 cc or less
- Staging 68Ga PSMA-11 PET-CT or MRI performed within 90 days before registration and before starting anti-androgen or androgen deprivation therapy, showing no distant metastases (nodes ≤1.5 cm short axis allowed)
- PSMA-avid primary intra-prostatic target lesion suitable for dose boost as determined by investigator
- Agreement to use adequate contraception (hormonal or barrier methods or abstinence) during SabR treatment and for 6 months afterward
- Ability to understand and willing to sign written informed consent
You will not qualify if you...
- Prior curative intent local therapy for prostate cancer (e.g., prostatectomy, radiotherapy, focal ablative therapy), except for specific androgen deprivation therapy conditions
- Prior androgen deprivation therapy allowed if less than 3 months total duration and stopped at least 3 months before registration with non-castrate testosterone recovery (>50 ng/dL) and meeting all other inclusion criteria
- Ongoing androgen deprivation therapy allowed if 60 days or less total duration with specified conditions for GnRH agonist and bicalutamide use
- Receiving any other investigational cancer treatment agents
- History of allergic reactions to PSMA-11 68Ga imaging agent
- Uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting study compliance
- Prior pelvic radiotherapy except for superficial or skin treatments
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75239
Actively Recruiting
2
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Not Yet Recruiting
Research Team
S
Sarah Neufeld
CONTACT
L
Liliana Robles
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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