SHORT Course Radiotherapy for Localized Prostate Cancer
- Conditions
- Health Condition 1: null- Prostate Cancer
- Registration Number
- CTRI/2016/02/006671
- Lead Sponsor
- Tata Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
•Histologically confirmed prostate adenocarcinoma.
•History/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration
•Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material.
•Clinical stage T1-T4N0M0 (AJCC 7th edition). Staging demands
oa multiparametric MRI of the pelvis
oa CT or MRI of the abdomen for T3/T4 tumors or PSA >10
oa whole body bone scan for T3/T4 tumors or PSA >10
•PSA < 60 ng/mL within 180 days prior to registration. PSA should not be obtained for at least 10 days after prostate biopsy.
•WHO performance status 0-1
•Age >= 18
•Patient must sign study specific informed consent prior to accrual.
•Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years.
•Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
•Previous pelvic irradiation in any form.
•Previous hormonal therapy of more than 180 days duration prior to registration.
•Previous or concurrent cytotoxic chemotherapy for prostate cancer
•Severe, active comorbidity, defined as follows:
oUnstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
oTransmural myocardial infarction within the last 6 months
oAcute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
oChronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
oHepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol. (Patients on Coumadin or other blood thinning agents are eligible for this study.)
oRenal insufficiency with a creatinine clearance of <30ml/min
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gr 2 or more acute gastrointestinal and genitourinary toxicity according to the NCI CTCAE v4Timepoint: Weekly during treatment and at 3 months following treatment completion.
- Secondary Outcome Measures
Name Time Method Freedom from biochemical recurrence (FFBR): <br/ ><br>Incidence of late GU and GI toxicity <br/ ><br>Quality of life <br/ ><br>Timepoint: 3 years