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PSMA PET Response Guided SabR in High Risk Pca

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

Study Description
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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

Condition or disease Intervention/treatment Phase
Prostate Adenocarcinoma Drug: 68-Ga PSMA11 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 7, 2024
Estimated Primary Completion Date : November 2026
Estimated Study Completion Date : November 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: 68-Ga PSMA11
Will be injected/assessed in line with its FDA label.
Other Name: Illucix, Telix
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.
 Drug: 68-Ga PSMA11
Will be injected/assessed in line with its FDA label.
Other Name: Illucix, Telix
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.
 Drug: 68-Ga PSMA11
Will be injected/assessed in line with its FDA label.
Other Name: Illucix, Telix
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.
 Drug: 68-Ga PSMA11
Will be injected/assessed in line with its FDA label.
Other Name: Illucix, Telix


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06044857


Contacts
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Contact: Sarah Neufeld 214-645-8525 Sarah.hardee@utsouthwestern.edu
Contact: Liliana Robles 214-645-8525 liliana.robles@utsouthwestern.edu

Locations
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United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75239
UT Southwestern Medical Center Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Sarah Neufeld    214-648-1836    Sarah.Neufeld@utsouthwestern.edu   
Contact: Liliana Robles    214-648-1836    Liliana.Robles@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Once Upon a Time Foundation
Telix Pharmaceuticals (Innovations) Pty Limited
Investigators
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Principal Investigator: Neil Desai, MD MHS Study Principal Investigator
More Information
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Responsible Party: Neil Desai, Associate Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT06044857    
Other Study ID Numbers: STU-2023-0566
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: March 12, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Gallium 68 PSMA-11
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action