New MRI-Guided radiation aims to tame recurrent prostate cancer with fewer side effects
NCT ID NCT07142967
First seen Jul 10, 2026 · Last updated Jul 10, 2026
Summary
This trial tests a precise form of radiation therapy guided by MRI and PSMA/PET imaging for men whose prostate cancer has returned after prior radiation. The goal is to see whether this approach can effectively treat the recurrent tumor while reducing serious urinary and bowel side effects. Participants will receive five focused radiation sessions along with hormone therapy for 4–6 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Stereotactic Body Radiation Therapy (SBRT) and Androgen Deprivation Therapy (ADT)
- What this could lead to
- If successful, this approach could offer a safer way to treat prostate cancer that has come back after initial radiation, potentially reducing severe urinary and bowel side effects.
- What could go wrong
- This is a small, early-phase study with only 28 participants, so results may not apply to everyone. The treatment still carries risks of serious side effects, and it is not a cure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2025
- Expected to finish
-
Aug 2030
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 18 years of age or older male participants 2. Biopsy proven intraprostatic prostate cancer after prior definitive external beam radiotherapy (moderate hypofractionation or Stereotactic Body Radiation Therapy (SBRT) acceptable). a. NOTE: Seminal vesicle involvement allowed 3. Pathology confirming recurrent disease must have evidence of viable cancer as indicated with pathology interpretation where a Gleason score can be assigned 4. Serum testosterone ≥ 50 ng/dL determined within 2 months prior to enrollment a. Prior Androgen Deprivation Therapy (ADT) use acceptable if testosterone level \>50ng/dL 5. At least 4 weeks must have elapsed from major surgery 6. Karnofsky Performance Scale (KPS) ≥ 80% or Eastern Cooperative Oncology Group (ECOG) 0-1 7. Prostate size as determined on MRI to be \< 90 cc. 8. International Prostatism Symptom Score (IPSS) ≤ 20 9. Patient must be available for follow-up. After 2 years of follow-up, upon completion of post-treatment biopsy, telephone, and chart review-based follow-up will be acceptable for up to 5 years 10. Presence of a T2 and/or DWI-visible prostatic lesion on mpMRI a. NOTE: Lesion visible on MRI required for enrollment but PSMA/PET avid lesion not required 11. Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form Exclusion Criteria: 1. History of prostate brachytherapy (low dose rate or high dose rate) 2. Actively undergoing androgen deprivation therapy and/or anti-androgens at time of enrollment 3. CT or MRI or PET scan evidence of extraprostatic disease 4. Patients with one or more positive lymph nodes considered suspicious as determined by clinical assessment on MRI or CT or PET scan 5. History of another malignancy within the previous 2 years except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, currently in complete remission, or any other cancer that has been in complete remission for at least 3 years 6. Patients with Crohn's disease or ulcerative colitis 7. MRI ineligibility due to: the presence of a cardiac pacemaker, defibrillator, or other implanted metallic or electronic device which is considered MR unsafe; severe claustrophobia; inability to lie flat for the duration of the study; etc. 8. Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of mp-MRI 9. Lateral pelvic separation greater than 50 cm and/or anterior-posterior separation greater than 35 cm which are incompatible with MRCAT reconstruction 10. Contra-indications to receiving gadolinium contrast or PSMA radioligand 11. Karnofsky Performance Scale (KPS) \< 80 or ECOG 2+ 12. Grade 3 or higher toxicity experienced after the initial course of External Beam Radiation Therapy (EBRT) 13. Disease free interval \< 2 years 14. Hx of Transurethral Resection Of Prostate (TURP) within the year 15. Prior high-intensity focused ultrasound (HIFU) or Cryotherapy 16. Prior history of urethral stricture 17. Unable to give informed consent 18. Unable to complete quality of life questionnaires
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Intraprostatic prostate cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
NYU Langone Health
RECRUITINGNew York, New York, 10016, United States