CTRI/2018/05/014054
Recruiting
Phase 3
Randomised controlled trial of Prostate Radiotherapy In high risk & node positive disease comparing Moderate & Extreme hypofractionation. - PRIME
Tata Memorial Centre Department of Atomic Energy Clinical Trial Centre0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- 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
- Sponsor
- Tata Memorial Centre Department of Atomic Energy Clinical Trial Centre
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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