Health Condition 1: null- Prostate Cancer
Conditions
Interventions
Intervention1: Extreme Hypofractionated Radiation Therapy: Radiotherapy with IMRT and daily CT based image guidance to a total dose of 3500cGy at 700 cGy per fraction, delivered one fraction per week
Sponsors
Tata Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: • 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 o a multiparametric MRI of the pelvis o a CT or MRI of the abdomen for T3/T4 tumors or PSA >10 o a whole body bone scan for T3/T4 tumors or PSA >10 • PSA • WHO performance status 0-1 • Age >= 18 • Patient must sign study specific informed consent prior to accrual.
Exclusion criteria
Exclusion criteria: • 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: o Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months o Transmural myocardial infarction within the last 6 months o Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration o Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration o Hepatic 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.) o Renal insufficiency with a creatinine clearance of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Freedom from biochemical recurrence (FFBR): Incidence of late GU and GI toxicity Quality of life Timepoint: 3 years | — |
Countries
India
Contacts
Public ContactDr Indranil Mallick
Tata Medical Center
Outcome results
None listed