PSMA PET Response Guided SabR in High Risk Pca

• ClinicalTrials.gov Identifier: NCT06044857
• Recruitment Status: Recruiting
• First Posted: September 21, 2023
• Last Update Posted: March 12, 2024
• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Once Upon a Time Foundation; Telix Pharmaceuticals (Innovations) Pty Limited
• Information provided by (Responsible Party): Neil Desai, University of Texas Southwestern Medical Center

Tracking Information

• First Submitted Date: July 27, 2023
• First Posted Date: September 21, 2023
• Last Update Posted Date: March 12, 2024
• Actual Study Start Date: March 7, 2024
• Estimated Primary Completion Date: November 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 12, 2023)

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

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: PSMA PET Response Guided SabR in High Risk Pca
• Official Title: Phase IB Study of Personalized Ultrahypofractionated Stereotactic Ablative Radiotherapy of High Risk PROstate Cancer Guided by PET PSMA (68Ga PMSA-11; Ilucix) Response (PULSAR ProPhet)
• 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
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Prostate Adenocarcinoma

Intervention

Drug: 68-Ga PSMA11

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

Other Name: Illucix, Telix

Study 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.
  Intervention: Drug: 68-Ga PSMA11
• 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.
  Intervention: Drug: 68-Ga PSMA11
• 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.
  Intervention: Drug: 68-Ga PSMA11
• 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.
  Intervention: Drug: 68-Ga PSMA11

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 12, 2023): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2026
• Estimated Primary Completion Date: November 2026 (Final data collection date for primary outcome measure)

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.

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):

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 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.

Sex/Gender

• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes

• Ages: 18 Years to 99 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Sarah Neufeld; 214-645-8525; Sarah.hardee@utsouthwestern.edu

Contact: Liliana Robles; 214-645-8525; liliana.robles@utsouthwestern.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06044857
• Other Study ID Numbers: STU-2023-0566
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Neil Desai, University of Texas Southwestern Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Texas Southwestern Medical Center
• Original Study Sponsor: Same as current

Collaborators

• Once Upon a Time Foundation
• Telix Pharmaceuticals (Innovations) Pty Limited

Investigators

• Principal Investigator: Neil Desai, MD MHS; Study Principal Investigator

• PRS Account: University of Texas Southwestern Medical Center
• Verification Date: March 2024