PSMA PET Response Guided SabR in High Risk Pca

NCT ID: NCT06044857

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-07
• Study Completion Date: 2026-11-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

68-Ga PSMA11

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

68-Ga PSMA11

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

68-Ga PSMA11

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

68-Ga PSMA11

Intervention Type: DRUG

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

Interventions

68-Ga PSMA11

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

Intervention Type: DRUG

Other Intervention Names

Illucix, Telix

Eligibility Criteria

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.

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.

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):

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Once Upon a Time Foundation

OTHER

Sponsor Role: collaborator

Telix Pharmaceuticals (Innovations) Pty Limited

INDUSTRY

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Neil Desai

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neil Desai, MD MHS

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status: RECRUITING

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Sarah Neufeld

Role: CONTACT

Sarah.hardee@utsouthwestern.edu

214-645-8525

Liliana Robles

Role: CONTACT

liliana.robles@utsouthwestern.edu

214-645-8525

Facility Contacts

Sarah Neufeld

Role: primary

Sarah.Neufeld@utsouthwestern.edu

214-648-1836

Liliana Robles

Role: backup

Liliana.Robles@utsouthwestern.edu

214-648-1836

Other Identifiers

STU-2023-0566

Identifier Type: -

Identifier Source: org_study_id