PSMA PET Response Guided SabR in High Risk Pca

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT06044857
Phase
PHASE1
Status
Recruiting
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Conditions

  • Prostate Adenocarcinoma

Eligibility Criteria

Sex
MALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • 68-Ga PSMA11 — DRUG
    Will be injected/assessed in line with its FDA label.

Study Details

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

Key Dates

Start date
Mar 7, 2024
Status verified
Apr 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SAbR Every other day
    SAbR given 2-3/week, at least every other day in spacing with long-term ADT (neoadjuvant ADT x 3months required) with experimental Illucix (PSMA-11 68Ga) PET before and during SAbR (between fraction 3 and 4) to assess and adapt to dominant intra-prostatic lesion boost dose.
  • Experimental: PULSAR every week
    SAbR given 1/week, with long-term ADT (neoadjuvant ADT x 3months required) with experimental Illucix (PSMA-11 68Ga) PET before and during SAbR (between fraction 3 and 4) to assess and adapt to dominant intra-prostatic lesion boost dose.
  • Experimental: PULSAR every 2 weeks
    SAbR given every 2 weeks, with long-term ADT (neoadjuvant ADT x 3months required) with experimental Illucix (PSMA-11 68Ga) PET before and during SAbR (between fraction 3 and 4) to assess and adapt to dominant intra-prostatic lesion boost dose.
  • Experimental: PULSAR every 3 weeks
    SAbR given every 3 weeks, with long-term ADT (neoadjuvant ADT x 3months required) with experimental Illucix (PSMA-11 68Ga) PET before and during SAbR (between fraction 3 and 4) to assess and adapt to dominant intra-prostatic lesion boost dose.

Primary Outcome Measure

Evaluation of Target Intra-Prostatic Lesion(s) [ Time Frame: Through end of neoadjuvant ADT at 3 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75239-
UT Southwestern Medical CenterDallasTexas75390
Sarah Neufeld
[email protected]
214-648-1836
Liliana Robles
[email protected]
214-648-1836

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By research site
University of Texas Southwestern Medical Center· Dallas, TXUT Southwestern Medical Center· Dallas, TX

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