Health Condition 1: null- 1.Participants must be histologically proven, adenocarcinoma prostate. 2. Localised to prostate or pelvic lymph nodes. Health Condition 2: N428- Other specified disorders of prostate
Conditions
Interventions
Intervention1: Extreme hypofractionated RT(Test arm): Patients in this arm will receive a course of 5 fractions of radiation
each fraction size will be 7.25 Gy. The total dose will be 36.25 Gy. All patients irrespective of nodal status will receive a dose of 25Gy in 5 # to the pelvic nodes. The 5 treatments will be schedule
Sponsors
Tata Memorial Centre Department of Atomic Energy Clinical Trial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants must be histologically proven, adenocarcinoma prostate 2. Localised to the prostate or pelvic lymph nodes 3. High risk prostate cancer as per NCCN definition clinical stage T3a or Gleason score 8/Gleason grade group4 or Gleason score 9-10/gleason grade group 5, PSA > 20 ng/mL.orVery high risk prostate cancer i.e T3b-T4 or Primary Gleason pattern 5/Gleason grade group 5 or > 4cores Gleason score8-10/Gleason grade group 4 or5 4. Ability to receive long term hormone therapy/ orchidectomy 5. KPS >70 6. No prior history of therapeutic irradiation to pelvis 7. Patient willing and reliable for follow-up and QOL 8. Signed study specific consent form
Exclusion criteria
Exclusion criteria: 1.Evidence of distant metastasis at anytime since presentation. 2. Life expectancy 3. Previous RT to prostate or prostatectomy. 4. A previous trans-urethral resection of the Prostate(TURP). 5. Severe urinary symptoms or with severe IPSS score ( >15) inspite of being on hormonal therapy for 6months which in the opinion of the physician precludes RT. 6. Patients with known obstructive symptoms with stricture. 7. Any containdication to radiotherapy like inflammatory bowel disease. 8. Uncontrolled co-morbidities including, but not limited to diabetes or hypertension. 9. Unable to follow up or poor logistic or social support.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the 4 year Biochemical Failure free Survival (BFFS) between the two arms..Timepoint: Four years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate acute and late toxicity with both treatments. 2. To find the Prostate cancer specific survival and overall survival of patients receiving moderately hypofractionated RT and SBRT. 3. To estimate the out of pocket expenditure involved in patients receiving the two treatment schedules. 4. To assess quality of life Timepoint: â?¢ All patients will follow up 3-6 weeks from end of radiotherapy, followed by 3-6 monthly for the first two years depending on the clinical need and 6 monthly thereafter. â?¢ QOL will be assessed at baseline and 6 monthly using the QLQC30 and PR25 EORTC Questionnaire. | — |
Countries
India
Contacts
Public ContactDr Vedang Murthy
TMH/ ACTREC
Outcome results
None listed