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PSMA PET-Guided Radiotherapy for Prostate Cancer

Phase 1

Recruiting

Led By Neil Desai, MD MHS

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through end of neoadjuvant adt at 3 months

Awards & highlights

Study Summary

This trial tested the best timing and spacing of imaging and treatment to get the best results from a PET scan to identify prostate cancer and adapt treatment.

Who is the study for?

Men over 18 with high-risk prostate cancer confirmed within the last 180 days, no distant metastases, and a PSMA-avid lesion in the prostate. They must plan to undergo stereotactic ablative radiotherapy (SabR) with hormone therapy, have an AUA IPSS score ≤18, a prostate size ≤100cc, and agree to use contraception during treatment and for six months after.Check my eligibility

What is being tested?

The trial is testing how well PET scans using a tracer called PSMA-11 can guide dose adjustments in SabR treatments for high-risk prostate cancer. It aims to find the best timing for imaging and treatment intervals to maximize response.See study design

What are the potential side effects?

Potential side effects include allergic reactions specific to the PSMA-11 imaging agent used in PET scans. The study does not detail other side effects; however, typical risks of PET scans are minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is high risk, confirmed by a recent test.

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I am 18 years old or older.

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I am scheduled for targeted radiation and hormone therapy for prostate cancer, with a small prostate and mild to moderate urinary symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through end of neoadjuvant adt at 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through end of neoadjuvant adt at 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through end of neoadjuvant adt at 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluation of Target Intra-Prostatic Lesion(s)

Trial Design

4Treatment groups

Experimental Treatment

Group I: SAbR Every other dayExperimental Treatment1 Intervention

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.

Group II: PULSAR every weekExperimental Treatment1 Intervention

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.

Group III: PULSAR every 3 weeksExperimental Treatment1 Intervention

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.

Group IV: PULSAR every 2 weeksExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

68-Ga PSMA11

2019

Completed Phase 2

~20

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Telix Pharmaceuticals (Innovations) Pty LimitedIndustry Sponsor

17 Previous Clinical Trials

1,326 Total Patients Enrolled

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,715 Total Patients Enrolled

Once Upon a Time FoundationOTHER

3 Previous Clinical Trials

307 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals being enrolled in this research trial?

"This experimental treatment is available to individuals aged 18-99. There are 9 trials for underage patients and 833 studies open to those over 65 years of age."

Answered by AI

Has the United States Food and Drug Administration given its seal of approval to SAbR Every other day?

"Since this is a Phase 1 trial, with limited information available on the safety and efficacy of SAbR Every Other Day, we gave it a score of 1."

Answered by AI

Are new participants being accepted into this clinical research initiative?

"Clinicaltrials.gov indicates that this clinical trial, which was first posted on September 1st 2023 and last edited a few weeks later, is not actively recruiting patients at the moment. However, 834 other medical studies are currently searching for participants."

Answered by AI

Could I qualify for this research project?

"To qualify for this trial, applicants must have been diagnosed with prostate adenocarcinoma and be between 18 and 99 years old. A total of 20 participants are being sourced."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PSMA PET Response Guided SabR in High Risk Pca

Neil Desai 2024. "PSMA PET Response Guided SabR in High Risk Pca". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06044857.