120 Participants Needed

Hypofractionated Radiation Therapy for Prostate Cancer

Recruiting at 7 trial locations
Age: 18+
Sex: Male
Trial Phase: Phase 1
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.

Research Team

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

Sean McBride, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

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

Eligibility is not restricted to MSKCC to confirm biopsy/diagnosis. Participating institution testing is sufficient
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.
See 5 more

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.
Unable to complete quality of life questionnaires
See 10 more

Treatment Details

Interventions

  • Hypofractionated, image-guided, intensity-modulated external beam radiation
Trial OverviewThe 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Montefiore Medical Center

Collaborator

Trials
468
Recruited
599,000+