Prostate Radiotherapy In high risk and node positive disease comparing Moderate & Extreme hypofractionation.

Phase 3

Conditions: 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

Registration Number: CTRI/2018/05/014054

Lead Sponsor: Tata Memorial Centre Department of Atomic Energy Clinical Trial Centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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

1.Evidence of distant metastasis at anytime since presentation.

2. Life expectancy <2 year.

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To assess the 4 year Biochemical Failure free Survival (BFFS) between the two arms..Timepoint: Four years

Secondary Outcome Measures

Name	Time	Method
1.To evaluate acute and late toxicity with both treatments. <br/ ><br>2.To find the Prostate cancer specific survival and overall survival of patients receiving moderately hypofractionated RT and SBRT. <br/ ><br>3.To estimate the out of pocket expenditure involved in patients receiving the two treatment schedules. <br/ ><br>4.To assess quality of life <br/ ><br>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. <br/ ><br>â?¢QOL will be assessed at baseline and 6 monthly using the QLQC30 and PR25 EORTC Questionnaire. <br/ ><br>