Prostate Adenocarcinoma study: 68-Ga PSMA11
Official title PSMA PET Response Guided SabR in High Risk Pca
ClinicalTrials.gov ID: NCT06044857
What this study is testing
What is 68-Ga PSMA11?
An investigational imaging agent being studied for prostate adenocarcinoma. It is designed to bind to prostate specific membrane antigen (PSMA) and emit a signal for PET imaging.
Also referred to as Illucix, Telix.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find the optimal schedule for imaging and treatment so that the PSMA PET scan best shows how the tumor responds, allowing doctors to adjust the radiation dose to the dominant tumor area.
- Who it's for
- Men with high‑risk prostate adenocarcinoma who are candidates for radiation therapy.
- What's involved
- Participants will receive PSMA PET scans (using PSMA‑11 68Ga) and then undergo radiation treatment with a possible dose boost to the dominant tumor area based on the scan results.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99, men only
You may be able to join if
- -Pathologically confirmed adenocarcinoma of the prostate (within 180 days of registration) of high risk by national comprehensive cancer network...
- Planned for definitive intent stereotactic ablative radiotherapy (SabR) with integrated dose boost to intra-prostatic tumor and androgen deprivation...
- Staging 68Ga PMSA-11 PET -CT or -MRI performed within 90 days of registration and before initiation of anti-androgen or androgen deprivation therapy...
- 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
You likely can't join if
- Prior curative intent local therapy (e.g. prostatectomy, radiotherapy, focal ablative therapy) for prostate cancer is not allowed, with following...
- people 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...
- Prior pelvic radiotherapy other than cutaneous/superficial treatments.
See the full eligibility 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...
- 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...
- 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...
- Ability to understand and the willingness to sign a written informed consent.
- 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...
- people 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...
- Prior pelvic radiotherapy other than cutaneous/superficial treatments.
The study team makes the final eligibility decision.
Where it is enrolling
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.