Trial Evaluating the Safety and Efficacy Of MR-Linac-Guided Radiotherapy as Salvage Treatment After External Beam Radiotherapy Recurrence (TUMORNATOR II)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: MRI scans, Biopsies
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The purpose of this study is to assess the impact of prostate-specific membrane antigen/positron emission tomography (PSMA/PET)-informed magnetic resonance (MR)-guided radiation therapy on serious toxicity outcomes in patients with biopsy-proven locally radiorecurrent prostate cancer."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety and effects of highly focused radiation guided by MRI and a PSMA/PET scan, which helps find prostate cancer. It is for men whose prostate cancer has returned after earlier external beam radiation. The study will check serious side effects, especially urinary problems, over 2 years.
The purpose of this study is to assess the impact of prostate-specific membrane antigen/positron emission tomography (PSMA/PET)-informed magnetic resonance (MR)-guided radiation therapy on serious toxicity outcomes in patients with biopsy-proven locally radiorecurrent prostate cancer. The primary aim is to evaluate the safety of delivering MR-Linac-guided stereotactic body radiotherapy (SBRT) after prior prostate external beam radiotherapy for recurrent disease, and assess urinary toxicity outcomes at 2 years.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Men age 18 or older whose prostate cancer has returned after external beam radiation. A tissue sample must show living cancer that can be graded.
- Cancer must be visible on MRI inside the prostate. Cancer in the nearby glands that make semen is allowed; a positive PSMA/PET scan is not required.
- Testosterone must be at least 50 ng/dL, tested within 2 months before joining. Past hormone treatment is allowed if testosterone is above 50 ng/dL.
- At least 4 weeks must have passed since major surgery.
- Must be able to do most daily activities, with a KPS score of at least 80 or an ECOG score of 0–1.
- Prostate size must be under 90 cc on MRI, and the urinary symptom score (IPSS) must be 20 or less.
- Must meet MRI safety rules and be willing to complete the MRI screening form.
- Must be available for follow-up and a tissue sample test after treatment. After 2 years and that test, follow-up may use phone calls and medical records through year 5.
Who can't join
- Past radiation placed inside the prostate, focused ultrasound treatment (HIFU), or freezing treatment. Current treatment that lowers or blocks male hormones is also not allowed.
- Scans show cancer outside the prostate or lymph nodes that look like they contain cancer. A cancer-free period of less than 2 years also rules out joining.
- Another cancer within the past 2 years, except certain treated skin cancers, surface bladder cancer in complete remission, or another cancer in complete remission for at least 3 years.
- Crohn’s disease or ulcerative colitis, which cause bowel swelling; past narrowing of the urine tube; or prostate surgery through that tube (TURP) within the past year.
- Cannot safely have MRI, lie flat for the scan, or tolerate tight spaces. Unsafe implants or pelvic metal that harms scan quality also rule out joining.
- Pelvis wider than 50 cm side to side or 35 cm front to back, or unable to receive gadolinium MRI dye or the PSMA scan tracer.
- Severe side effects, grade 3 or higher, after the first radiation treatment, or activity scores below KPS 80 or ECOG 2 or higher.
- Unable to give informed consent or complete surveys about quality of life.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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
Study sites (1)
NY
- NYU Langone Health · New York, NY 10016More trials in New York