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PSMA PET Response Guided SabR in High Risk Pca

Primary Purpose

Prostate Adenocarcinoma

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
68-Ga PSMA11
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Adenocarcinoma

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

SAbR Every other day

PULSAR every week

PULSAR every 2 weeks

PULSAR every 3 weeks

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 27, 2023
Last Updated
September 12, 2023
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Once Upon a Time Foundation, Telix International Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT06044857
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Once Upon a Time Foundation, Telix International Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SAbR Every other day
Arm Type
Experimental
Arm Description
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.
Arm Title
PULSAR every week
Arm Type
Experimental
Arm Description
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.
Arm Title
PULSAR every 2 weeks
Arm Type
Experimental
Arm Description
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.
Arm Title
PULSAR every 3 weeks
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
68-Ga PSMA11
Other Intervention Name(s)
Illucix, Telix
Intervention Description
Will be injected/assessed in line with its FDA label.
Primary Outcome Measure Information:
Title
Evaluation of Target Intra-Prostatic Lesion(s)
Description
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.
Time Frame
Through end of neoadjuvant ADT at 3 months

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Neufeld
Phone
214-645-8525
Email
Sarah.hardee@utsouthwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Liliana Robles
Phone
214-645-8525
Email
liliana.robles@utsouthwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Desai, MD MHS
Organizational Affiliation
Study Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Neufeld
Phone
214-648-1836
Email
Sarah.Neufeld@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Liliana Robles
Phone
214-648-1836
Email
Liliana.Robles@utsouthwestern.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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PSMA PET Response Guided SabR in High Risk Pca

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