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NCT06542757 | RECRUITING | Prostate Cancer

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
Sponsor:

NYU Langone Health

Brief Summary:

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.

Condition or disease

Prostate Cancer

Intervention/treatment

1.5 T Elekta Unity MR-Linac system

Hydrogel rectal spacer (SpaceOAR)

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 91 participants
Masking : NONE
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2024-12-09
Estimated Primary Completion Date : 2025-11
Estimated Study Completion Date : 2027-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 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
    • * PSA 10-20 ng/ml or
    • * Gleason score = 7 or
    • * 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)
    • 2. Age \> 18
    • 3. Karnofsky Performance Status (KPS) \> 80
    • 4. Prostate size \< 90 cc
    • 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
    • 6. MRI findings: Lesion may contact the capsular edge, possible extracapsular extension (ECE) permitted
    • 7. International Prostate Symptom Score \< 18
    • 8. Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form
    Exclusion Criteria
    • 1. Gleason score \>7
    • 2. PSA \>20 ng/mL
    • 3. Prior or concurrent androgen deprivation therapy for prostate cancer
    • 4. MRI findings: suspicious for/probable ECE
    • 5. MRI findings: \>2 disease foci identifiable
    • 6. Evidence of metastatic disease on bone scan or MRI/CT
    • 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 MR for Calculating ATtenuation (MRCAT) reconstruction
    • 10. Contra-indications to receiving gadolinium contrast
    • 11. KPS \< 80
    • 12. Pelvic or Prostate MRI or CT (MRI preferred) evidence of radiographic T3, T4, or N1 disease
    • 13. Prior history of transurethral resection of the prostate
    • 14. Prior history of urethral stricture
    • 15. Prior history of pelvic irradiation
    • 16. History of inflammatory bowel disease
    • 17. Unable to give informed consent
    • 18. Unable to complete quality of life questionnaires
    • 19. Abnormal complete blood count, including any of the following
      • * Platelet count less than 75,000/ml
      • * Hb level less than 10 gm/dl
      • * White blood cell (WBC) less than 3.5/ml
      • * Abnormal renal function tests (creatinine \> 1.5)
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

Location Details

NCT06542757

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Locations

RECRUITING

United States, New York

NYU Langone Health

New York, New York, United States, 10016