PSMA PET Response Guided SabR in High Risk Pca
Conditions
Prostate AdenocarcinomaDrugs
68-Ga PSMA11Summary
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
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Central Contacts
- Sarah Neufeld
- 214-645-8525
- [email protected]
Principal Investigator
- Neil Desai, MD MHS
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.
Study Plan
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 PSMA11Description:
Will be injected/assessed in line with its FDA label.
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 PSMA11Description:
Will be injected/assessed in line with its FDA label.
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 PSMA11Description:
Will be injected/assessed in line with its FDA label.
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 PSMA11Description:
Will be injected/assessed in line with its FDA label.
Outcome Measures
Primary Outcome Measures
Evaluation of Target Intra-Prostatic Lesion(s)
Timeline
Last Updated
March 12, 2024Start Date
September 21, 2023Today
February 5, 2025Completion Date ( Estimated )
November 1, 2026
Sponsors of this trial
Lead Sponsor
University of Texas Southwestern Medical CenterCollaborating Sponsors
Once Upon a Time Foundation, Telix Pharmaceuticals (Innovations) Pty Limited