RECRUITING

Evaluation of Tumor Control Based on Serial Multiparametric MRI and Post-Treatment Biopsies For Patients Treated With Dose Intensification to the Dominant Intra-Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR-Guided Radiotherapy

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Conditions

Prostate Cancerintensity-modulated radiotherapyMR-guided

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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 this MR-guided radiotherapy on tumor control of the dominant intraprostatic lesion among patients with intermediate risk prostate cancer. This study of Radiotherapy to the Prostate and Dominant Lesion Using Ultra-Hypofractionated, MR-adaptive Radiation Therapy aims to evaluate tumor control after definitive ultra-hypofractionated external beam radiation therapy (including a simultaneously delivered high-dose boost to a dominant lesion as detected on prostate magnetic resonance imaging (MRI)) in patients with intermediate-risk prostate cancer. This will incorporate the use of multiparametric MRI for target segmentation and the use of the MR-linac with adaptive radiation planning to treat the prostate gland, incorporating a dose boost to the dominant intraprostatic lesion (DIL) that is visible on T2-weighted and diffusion-weighted imaging and de-escalation of dose to the remainder of the prostate.

Official Title

Evaluation of Tumor Control Based on Serial Multiparametric MRI and Post-Treatment Biopsies For Patients Treated With Dose Intensification to the Dominant Intra-Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR-Guided Radiotherapy (TUMORNATOR I)

Quick Facts

Study Start:2024-12-09
Study Completion:2027-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06542757

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. Intermediate-risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per National Comprehensive Cancer Network (NCCN) guidelines. Intermediate-risk patients will be defined as:
  2. * PSA 10-20 ng/ml or
  3. * Gleason score = 7 or
  4. * Clinical stage T2b/T2c (T2b: the tumor has spread to more than one-half of one side of the prostate, but not to both sides. T2c: the cancer has invaded both sides of the prostate)
  5. 2. Age \> 18
  6. 3. Karnofsky Performance Status (KPS) \> 80
  7. 4. Prostate size \< 90 cc
  8. 5. Presence of a T2-visible prostatic lesion with maximum dimension of ≥ 0.5 cm and no more than two additional disease foci with a documented Prostate Imaging Reporting and Data System (PIRADS) 4-5 lesion
  9. 6. MRI findings: Lesion may contact the capsular edge, possible extracapsular extension (ECE) permitted
  10. 7. International Prostate Symptom Score \< 18
  11. 8. Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form
  1. 1. Gleason score \>7
  2. 2. PSA \>20 ng/mL
  3. 3. Prior or concurrent androgen deprivation therapy for prostate cancer
  4. 4. MRI findings: suspicious for/probable ECE
  5. 5. MRI findings: \>2 disease foci identifiable
  6. 6. Evidence of metastatic disease on bone scan or MRI/CT
  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 MR for Calculating ATtenuation (MRCAT) reconstruction
  10. 10. Contra-indications to receiving gadolinium contrast
  11. 11. KPS \< 80
  12. 12. Pelvic or Prostate MRI or CT (MRI preferred) evidence of radiographic T3, T4, or N1 disease
  13. 13. Prior history of transurethral resection of the prostate
  14. 14. Prior history of urethral stricture
  15. 15. Prior history of pelvic irradiation
  16. 16. History of inflammatory bowel disease
  17. 17. Unable to give informed consent
  18. 18. Unable to complete quality of life questionnaires
  19. 19. Abnormal complete blood count, including any of the following:
  20. * Platelet count less than 75,000/ml
  21. * Hb level less than 10 gm/dl
  22. * White blood cell (WBC) less than 3.5/ml
  23. * Abnormal renal function tests (creatinine \> 1.5)

Contacts and Locations

Study Contact

Michael Zelefsky, M.D
CONTACT
212-731 5517
Michael.Zelefsky@nyulangone.org

Principal Investigator

Michael Zelefsky, M.D
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, M.D, 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 Date2024-12-09
Study Completion Date2027-11

Study Record Updates

Study Start Date2024-12-09
Study Completion Date2027-11

Terms related to this study

Keywords Provided by Researchers

  • intensity-modulated radiotherapy
  • MR-guided

Additional Relevant MeSH Terms

  • Prostate Cancer