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

Trial 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

NCT ID: NCT06542757

Condition: Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
intensity-modulated radiotherapy
MR-guided

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: 1.5 T Elekta Unity MR-Linac system
Description: Patients will receive 9 Gy/fraction (45 Gy total) for five fractions to the DIL, while the remainder of the prostate will be treated to 30 Gy in 5 fractions.
Arm group label: MRI-guided Intensity Modulated Radiotherapy

Intervention type: Device
Intervention name: Hydrogel rectal spacer (SpaceOAR)
Description: A rectal spacer will be placed one week prior to simulation to achieve a separation of approximately 1 cm between the prostate and anterior rectal wall to further minimize rectal toxicity in these patients. The hydrogel will remain in the body for about 12 weeks.
Arm group label: MRI-guided Intensity Modulated Radiotherapy

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.

Criteria for eligibility:
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)

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: NYU Langone Health

Address:
City: New York
Zip: 10016
Country: United States

Start date: August 12, 2024

Completion date: November 2027

Lead sponsor:
Agency: NYU Langone Health
Agency class: Other

Source: NYU Langone Health

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06542757