A Phase I Feasibility Study of Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR Image-Guided, Intensity-Modulated Radiotherapy

Memorial Sloan Kettering Cancer Center7 sites in 1 country35 target enrollmentAugust 28, 2017

ConditionsProstate Cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 35
Locations: 7
Primary Endpoint: Treatment related toxicity of ultra-hypofractionated radiotherapy will be assessed according to NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity
Status: Active, not recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to find out the feasibility and effects of ultra-hypofractionated radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate risk prostrate cancer.

Registry

clinicaltrials.gov

Start Date

August 28, 2017

End Date

August 28, 2026

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•Additionally, patients will be required to meet the following criteria:
•KPS \> 80
•Prostate size \< 60cc
•Presence of a prostatic lesion with maximum dimension of \>/= 0.5cm and no more than two additional disease foci, each with a maximum dimension less than that of the dominant lesion.
•International Prostrate Symptom Score \< 15
•Subjects must fill out the standard MRI screening form and satisfy all MRI screening criteria

Exclusion Criteria

•Prior androgen deprivation therapy for prostate cancer
•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 or inability to lie flat for the duration of the study, etc.
•Metallic hip implant, metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of MP-MRI.
•Lateral pelvic separation greater than 50 cm and/or anterior-posterior separation greater than 35 cm which are incompatible with MRCAT reconstruction
•Contra-indications to receiving gadolinium contrast
•KPS \< 80
•Pelvic MRI or CT (MRI preferred) evidence of radiographic T3, T4 or N1 disease.
•Prior history of transurethral resection of the prostate
•Prior history of chronic prostatitis

Outcomes

Primary Outcomes

Treatment related toxicity of ultra-hypofractionated radiotherapy will be assessed according to NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity

Time Frame: 36 months

Assess toxicity of ultra-hypofractionated radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate risk prostate cancer. Severe Toxicity will be assessed and defined as Grade 3 or higher NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity