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 Number: NCT06542757
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prostate Cancer
Interventions: RADIATION: 1.5 T Elekta Unity MR-Linac system|DEVICE: Hydrogel rectal spacer (SpaceOAR)
Sponsor: NYU Langone Health
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 91
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-12
Completion Date: 2027-11
Locations: NYU Langone Health, New York, New York, 10016, United States

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.

Primary Outcome Measures: Negative biopsy rate 24 months post-treatment, Outcome measure will be assessed via repeat biopsy of the dominant lesion as seen on mp-MRI, 24 months post-treatment|Serious toxicity rate 24 months post-treatment, Outcome measure will be assessed using NCI CTCAE v5.0 for gastrointestinal and genitourinary toxicity., 24 months post-treatment
Secondary Outcome Measures: Prostate Specific Antigen (PSA) relapse rate at 24 months post-treatment, 24 months post-treatment|Proportion of patients with radiation-induced response in the dominant prostatic lesion 6 months post treatment, Outcome measure will be assessed using multi-parametric MR imaging., 6 months post-treatment|Proportion of patients with radiation-induced response in the dominant prostatic lesion 24 months post treatment, Outcome measure will be assessed using multi-parametric MR imaging., 24 months post-treatment|Change in International Prostate Symptom Score (I-PSS), The I-PSS is based on the answers to seven questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Score are classified as follows: 0 - 7 = mildly symptomatic; 8 - 19 = moderately symptomatic; 20 - 35 = severely symptomatic., Baseline, Month 3|Change in International Prostate Symptom Score (I-PSS), The I-PSS is based on the answers to seven questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Score are classified as follows: 0 - 7 = mildly symptomatic; 8 - 19 = moderately symptomatic; 20 - 35 = severely symptomatic., Baseline, Month 6|Change in International Prostate Symptom Score (I-PSS), The I-PSS is based on the answers to seven questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Score are classified as follows: 0 - 7 = mildly symptomatic; 8 - 19 = moderately symptomatic; 20 - 35 = severely symptomatic., Baseline, Month 12-18|Change in International Index of Erectile Function (IIEF) score, The IIEF consists of 11 items, grouped into five factors: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Items are scored in a 1-5 Likert-type scale, with higher scores indicating better erectile function. Erectile dysfunction (ED) severity is classified into five categories: no ED (score 22-25), mild (17-21), mild to moderate (12-16), moderate (8-11), and severe (5-7)., Baseline, Month 3|Change in International Index of Erectile Function (IIEF) score, The IIEF consists of 11 items, grouped into five factors: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Items are scored in a 1-5 Likert-type scale, with higher scores indicating better erectile function. ED severity is classified into five categories: no ED (score 22-25), mild (17-21), mild to moderate (12-16), moderate (8-11), and severe (5-7)., Baseline, Month 6|Change in International Index of Erectile Function (IIEF) score, The IIEF consists of 11 items, grouped into five factors: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Items are scored in a 1-5 Likert-type scale, with higher scores indicating better erectile function. ED severity is classified into five categories: no ED (score 22-25), mild (17-21), mild to moderate (12-16), moderate (8-11), and severe (5-7)., Baseline, Month 12-18|Change in genomic classifier (GC) Decipher score, Scores are derived from the expression of 22 genes. Decipher scores are a continuous variable reported on a scale of 0 to 1. These scores are then stratified to three risk-categories: low (\<0.45), intermediate (≥ 0.45 - \< 0.6) and high (≥ 0.6), Baseline, 6 months post-treatment|Change in GC Decipher score, Scores are derived from the expression of 22 genes. Decipher scores are a continuous variable reported on a scale of 0 to 1. These scores are then stratified to three risk-categories: low (\<0.45), intermediate (≥ 0.45 - \< 0.6) and high (≥ 0.6), Baseline, 24 months post-treatment