Not Yet RecruitingEarly Phase 1

Response With Interim PSMA PET in Metastatic Castration-sensitive Prostate Cancer for Optimization of Adaptive Metastasis-directed Radiotherapy Delivery

United States30 participantsStarted 2026-07-15

Plain-language summary

The purpose of this study is to characterize the reduction in PSMA-avid tumor volume and metastasis-directed radiotherapy treatment intensity facilitated by PET PSMA-response adapted SABR for poly-metastatic castration sensitive prostate cancer.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. History of pathologically confirmed prostate cancer.
. Age \>=18 years.
. Performance status ECOG 0-2.
. Staging 68Ga PMSA-11 PET/CT showing 4-20 sites of metastasis from prostate cancer within \<=90 days prior to registration. This scan ideally should be performed before initiation of androgen deprivation therapy (ADT).
. At the discretion of the treating investigator, it is believed that it is safe to treat all sites of disease using SABR.
. 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 patient's partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reduction in PSMA-positive TTV

Timeframe: 1 YEAR

Reduction in SABR treatment intensity

Timeframe: 1 YEAR

Trial details

NCT IDNCT07674771

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-06-15

Contact for this trial

SARAH NEUFELD, MS, MBA

214 645 8525 sarah.hardee@UTSouthwestern.edu

View on ClinicalTrials.gov More Prostate Cancer trials

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. History of pathologically confirmed prostate cancer.
. Age \>=18 years.
. Performance status ECOG 0-2.
. Staging 68Ga PMSA-11 PET/CT showing 4-20 sites of metastasis from prostate cancer within \<=90 days prior to registration. This scan ideally should be performed before initiation of androgen deprivation therapy (ADT).
. At the discretion of the treating investigator, it is believed that it is safe to treat all sites of disease using SABR.
. 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 patient's partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Response With Interim PSMA PET in Metastatic Castration-sensitive Prostate Cancer for Optimization of Adaptive Metastasis-directed Radiotherapy Delivery

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Response With Interim PSMA PET in Metastatic Castration-sensitive Prostate Cancer for Optimization of Adaptive Metastasis-directed Radiotherapy Delivery

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria