Prostate Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

120

Study ID:

NCT00911118

Recruitment Status:

Active, not recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 5 Locations for this study

See Locations Near You

Montefiore Medical Center
Bronx New York, 10467, United States
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack New York, 11725, United States
Memorial Sloan Kettering West Harrison
Harrison New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre New York, , United States
Memoral Sloan Kettering Cancer [email protected]
Sleepy Hollow New York, , United States
Memorial Sloan Kettering Nassau
Uniondale New York, 11553, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

120

Study ID:

NCT00911118

Recruitment Status:

Active, not recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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