Hypofractionated Radiation Therapy for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+7 other locations

Sean McBride, MD, MPH - MSK Radiation ...

Overseen ByMichael Zelefsky, MD

Age: 18+

Sex: Male

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Men aged 18 or older with low to intermediate risk prostate cancer, defined by specific PSA levels, Gleason scores, and clinical stages. They must have a good performance status (able to carry out daily activities), no severe urinary symptoms, a prostate size ≤60 cc, and no evidence of advanced disease on MRI/CT scans.

Inclusion Criteria

My prostate cancer is low risk with a PSA of 10 or less, Gleason score of 6, and stage T2a or lower.

My prostate cancer is at an intermediate stage with specific PSA levels and Gleason score.

I am 18 years old or older.

I am mostly able to care for myself.

My prostate symptoms are mild.

My prostate is 60 cc or smaller.

Exclusion Criteria

I have a history of inflammatory bowel disease.

I am unable to understand and agree to the study's details on my own.

I am choosing to have radiation therapy on my pelvic lymph nodes.

I have had a urethral stricture in the past.

I have had radiation therapy to my pelvic area before.

My physical condition limits my ability to care for myself.

My scans show my cancer has spread to nearby tissues or lymph nodes.

My cancer has spread to distant parts of my body, confirmed by specific tests.

I have had surgery to remove part of my prostate.

I have undergone hormone therapy for prostate cancer.

I have a history of long-term prostate inflammation.

Participant Groups

The trial is testing an advanced form of radiation therapy for prostate cancer called ultra-hypofractionated IG-IMRT. It involves fewer treatment sessions (5 over two weeks) with higher doses each time compared to the standard 45-48 treatments.

1Treatment groups

Experimental Treatment

Group I: RadiationExperimental Treatment1 Intervention

Patients enrolled in the study will undergo image-guided, intensity-modulated radiotherapy using the same equipment, techniques, and treatment-planning procedures as currently practiced as MSKCC. MSKCC patients will have the option of continued follow-up through MSKCC's established Prostate Survivorship Clinic for an indefinite period of time, meaning patients enrolled in the protocol will be encouraged to remain at MSKCC for life-long follow-up after their treatment. The standard assessments obtained in the Survivorship Clinic will not be altered. All protocol relevant data collected at these visits through month 60 will be used for protocol analysis.