Dose Escalation Study Using Ultra-Hypofractionated, Image-Guided, Intensity-Modulated Radiotherapy in Prostate Cancer

Completed · Phase 1

Conditions studied: Prostate Cancer, Adenocarcinoma

In brief

The purpose of this study is to test the safety of a new type of IG-IMRT called "ultra-hypofractionated IG-IMRT" where a higher dose of radiation is given to the tumor during each treatment day. Since higher doses of radiation are used each day, the total number of treatment days needed to complete this type of radiation is only five instead of the 45-48 treatments currently used. Treatment takes place every other day and is complete after 2 weeks. If the patient decides to get this treatment, they will come in for 5 treatments. This is different from the 48 treatments they would get normally.

Key facts

Study ID

NCT00911118

Run by

Memorial Sloan Kettering Cancer Center

People needed

120

Starts

2009-05-26

Expected to finish

2026-05-14

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Eligibility is not restricted to MSKCC to confirm biopsy/diagnosis. Participating institution testing is sufficient.
• Low and intermediate risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines.
• Low risk patients will be defined as:
• PSA < or = to 10 ng/ml and
• Gleason score = 6 and
• Clinical Stage < or = to T2a
• Intermediate risk patients will be defined as:
• PSA 10-20 ng/ml or
• Gleason score = 7 or
• Clinical stage T2b/T2c
• Additionally, patients will be required to meet the following criteria:
• Age > or = to 18
• KPS > or = to 70
• Pre-treatment endorectal coil MRI or CT (MRI preferred) at MSKCC showing no definite evidence of radiographic T3, T4, or N1 disease
• Prostate size < or = to 60 cc
• International Prostate Symptom Score < or = to 15

You may not qualify if…

• Prior androgen deprivation therapy for prostate cancer
• Elective pelvic lymph node irradiation
• KPS < 70
• Pelvic MRI or CT (MRI preferred) evidence of radiographic T3, T4 or N1 disease
• Presence of distant metastasis as determined by:
• o alkaline phosphatase > or = to ULN or
• whole body bone scan positive for osseous metastases
• Prior history of transurethral resection of the prostate
• Prior history of chronic prostatitis
• Prior history of urethral stricture
• Prior history of pelvic irradiation
• History of inflammatory bowel disease
• Unable to give informed consent
• Unable to complete quality of life questionnaires Abnormal complete blood count. 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)

Where it is running

• Memorial Sloan Kettering Cancer Center @ Suffolk — Commack, New York, United States
• Memorial Sloan Kettering West Harrison — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering at Mercy Medical Center — Rockville Centre, New York, United States
• Memorial Sloan Kettering Cancer Center@Phelps — Sleepy Hollow, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Memorial Sloan Kettering Nassau — Uniondale, New York, United States

Full record on ClinicalTrials.gov

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