MR-Guided Radiotherapy for Intermediate-Risk 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
Recruiting
N/AInterventional Study
Prostate Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Male
Study type
Interventional
Purpose
Treatment
Participants needed
91 (estimated)
Sponsor
NYU Langone Health · Other
Who this trial is looking for
This trial is looking for men with intermediate-risk prostate cancer to see how effective a specific type of radiotherapy is in controlling their tumors. Participants will receive a higher dose of treatment to the most affected area of the prostate, guided by MRI scans.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with intermediate-risk prostate cancer.
I am over 18 years old.
I have a Karnofsky Performance Status higher than 80.
I have a prostate size smaller than 90 cc.
I have a visible prostatic lesion of at least 0.5 cm.
I have an International Prostate Symptom Score under 18.
I am willing to complete an MRI screening.
You may not be able to join if
I have a Gleason score higher than 7.
My PSA level is over 20 ng/mL.
I have received androgen deprivation therapy for prostate cancer.
I have signs of metastatic disease.
I have a cardiac implant that is not safe for MRI.
I cannot lie flat for the MRI duration.
I have had a history of pelvic irradiation.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 r…
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.
Trial Locations
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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
* Clin…
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)
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