NCT04997018Active, not recruitingPhase 2
A Study of MRI-guided High-dose Radiation Therapy in Prostate Cancer
A Phase II Study of Radiotherapy to the Prostate and Dose Intensification to the Dominant Intra- Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR-Guided Radiotherapy
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
One of the usual approaches to treating intermediate-risk prostate cancer is a type of radiation therapy called SBRT (stereotactic body radiation therapy). SBRT delivers higher than standard doses of radiation over a lower number of treatment sessions. However, there is a 20% chance that intermediate-risk prostate cancer will come back after this treatment. The purpose of this study is to find out whether giving an even higher dose (a "boost" dose) of radiation directly to the main tumor and the standard dose of radiation to the rest of the prostate may cure the cancer or prevent it from coming back for a longer period of time while causing few side effects.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 91 (actual)
- First submitted
- 4 Aug 2021
- Start date
- 4 Aug 2021
- Primary completion date
- 4 Aug 2027
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Prostate cancer
- NCT number
- NCT04997018
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 91
- From 4 Aug 2021 to the primary completion date, 4 Aug 2027
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or concurrent androgen deprivation therapy for prostate cancer MRI findings: suspicious for/probable ECE
- Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of mp-MRI
- Contra-indications to receiving gadolinium contrast
- Prior history of transurethral resection of the prostate
- Prior history of urethral stricture
- Prior history of pelvic irradiation
Other illness
- MRI findings: \>2 disease foci identifiable
- Evidence of metastatic disease on bone scan or MRI/CT
- 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.
- Pelvic or prostate MRI or CT (MRI preferred) evidence of radiographic T3, T4, or N1 disease
- History of inflammatory bowel disease
Lab values
- Abnormal complete blood count, including any of the following:
- Platelet count less than 75,000/ml
- Hb level less than 10 gm/dl
- WBC less than 3.5/ml
- Abnormal renal function tests (creatinine \> 1.5)
Other
- Patient will be excluded if they meet any one of the following criteria:
- Gleason score \>7
- PSA \>20
- Lateral pelvic separation greater than 50 cm and/or anterior-posterior separation greater than 35 cm which are incompatible with MRCAT reconstruction
- KPS \< 80
- Unable to give informed consent
- Unable to complete quality of life questionnaires
Who the study is looking for
- Intermediate-risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines. Intermediate-risk patients will be defined as:
- PSA 10-20 ng/ml or
- Gleason score = 7 or
- Clinical stage T2b/T2c or
- Additionally, patients will be required to meet all of the following criteria:
- Age ≥ 18
- Karnofsky Performance Status (KPS) ≥ 80 (Appendix 1)
- Prostate size ≤ 80 cc
- Presence of a T2-visible prostatic lesion with maximum dimension of ≥ 0.5 cm and no more than one additional disease focus
- MRI findings: Lesion may contact the capsular edge, possible extracapsular extension (ECE) permitted
- International Prostate Symptom Score ≤ 15
- Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities) Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| Memorial Sloan Kettering at Westchester (Limited Protocol Activities) Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| Memorial Sloan Kettering at Monmouth (Limited Protocol Activities) Coordinator of this site? Confirm its status | Middletown | United States | Unknown status |
| Memorial Sloan Kettering at Bergen (Limited Protocol Activities) Coordinator of this site? Confirm its status | Montvale | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan Kettering at Nassau (Limited Protocol Activities) Coordinator of this site? Confirm its status | Uniondale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.