RECRUITING

Trial Evaluating the Safety and Efficacy Of MR-Linac-Guided Radiotherapy as Salvage Treatment After External Beam Radiotherapy Recurrence (TUMORNATOR II)

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Conditions

Intraprostatic Prostate Cancerprostate adenocarcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Trial Evaluating the Safety and Efficacy Of MR-Linac-Guided Radiotherapy as Salvage Treatment After External Beam Radiotherapy Recurrence (TUMORNATOR II)

Quick Facts

Study Start:2025-08-15
Study Completion:2029-08-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07142967

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18 years of age or older male participants
  2. 2. Biopsy proven intraprostatic prostate cancer after prior definitive external beam radiotherapy (moderate hypofractionation or Stereotactic Body Radiation Therapy (SBRT) acceptable).
  3. 3. Pathology confirming recurrent disease must have evidence of viable cancer as indicated with pathology interpretation where a Gleason score can be assigned
  4. 4. Serum testosterone ≥ 50 ng/dL determined within 2 months prior to enrollment
  5. 5. At least 4 weeks must have elapsed from major surgery
  6. 6. Karnofsky Performance Scale (KPS) ≥ 80% or Eastern Cooperative Oncology Group (ECOG) 0-1
  7. 7. Prostate size as determined on MRI to be \< 90 cc.
  8. 8. International Prostatism Symptom Score (IPSS) ≤ 20
  9. 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. 10. Presence of a T2 and/or DWI-visible prostatic lesion on mpMRI
  11. 11. Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form
  1. 1. History of prostate brachytherapy (low dose rate or high dose rate)
  2. 2. Actively undergoing androgen deprivation therapy and/or anti-androgens at time of enrollment
  3. 3. CT or MRI or PET scan evidence of extraprostatic disease
  4. 4. Patients with one or more positive lymph nodes considered suspicious as determined by clinical assessment on MRI or CT or PET scan
  5. 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. 6. Patients with Crohn's disease or ulcerative colitis
  7. 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. 8. Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of mp-MRI
  9. 9. Lateral pelvic separation greater than 50 cm and/or anterior-posterior separation greater than 35 cm which are incompatible with MRCAT reconstruction
  10. 10. Contra-indications to receiving gadolinium contrast or PSMA radioligand
  11. 11. Karnofsky Performance Scale (KPS) \< 80 or ECOG 2+
  12. 12. Grade 3 or higher toxicity experienced after the initial course of External Beam Radiation Therapy (EBRT)
  13. 13. Disease free interval \< 2 years
  14. 14. Hx of Transurethral Resection Of Prostate (TURP) within the year
  15. 15. Prior high-intensity focused ultrasound (HIFU) or Cryotherapy
  16. 16. Prior history of urethral stricture
  17. 17. Unable to give informed consent
  18. 18. Unable to complete quality of life questionnaires

Contacts and Locations

Study Contact

Michael Zelefsky, MD
CONTACT
646-239-9083
Michael.zelefsky@nyulangone.org

Principal Investigator

Michael Zelefsky, MD
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

NYU Langone Health
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Michael Zelefsky, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-15
Study Completion Date2029-08-02

Study Record Updates

Study Start Date2025-08-15
Study Completion Date2029-08-02

Terms related to this study

Keywords Provided by Researchers

  • prostate adenocarcinoma

Additional Relevant MeSH Terms

  • Intraprostatic Prostate Cancer