PSMA PET Response Guided SabR in High Risk Pca

NCT06044857 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: STU-2023-0566
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Evaluation of Target Intra-Prostatic Lesion(s)

  This study primarily evaluates volume reduction of initial target PSMA-avid dominant intra-prostatic disease after neoadjuvant ADT and during SAbR in differing spacing regimens of SAbR. Metrics include percent reduction in volume at 3 months of therapy vs initial disease extent of intra-prostatic dominant lesion as identified by PSMA PET.

  Through end of neoadjuvant ADT at 3 months

Study Arms (4)

SAbR Every other day

EXPERIMENTAL

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.

Drug: 68-Ga PSMA11

PULSAR every week

EXPERIMENTAL

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.

Drug: 68-Ga PSMA11

PULSAR every 2 weeks

EXPERIMENTAL

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.

Drug: 68-Ga PSMA11

PULSAR every 3 weeks

EXPERIMENTAL

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.

Drug: 68-Ga PSMA11

Interventions

68-Ga PSMA11 DRUG

Will be injected/assessed in line with its FDA label.

Also known as: Illucix, Telix

PULSAR every 2 weeks; PULSAR every 3 weeks; PULSAR every week; SAbR Every other day

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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):
• 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.
• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Once Upon a Time Foundation: collaborator
• Telix Pharmaceuticals (Innovations) Pty Limited: collaborator

Study Sites (2)

University of Texas Southwestern Medical Center

Dallas, Texas, 75239, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

NOT YET RECRUITING

MeSH Terms

Interventions

gallium 68 PSMA-11

Study Officials

• Neil Desai, MD MHS

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Neufeld

CONTACT

214-645-8525; Sarah.hardee@utsouthwestern.edu

Liliana Robles

CONTACT

214-645-8525; liliana.robles@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: September 21, 2023
• Study Start: March 7, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (2)