NCT02302105Active, not recruiting
Randomized Trial of Prostate Only or Pelvic RT in High Risk Prostate Cancer
Prospective Phase III Randomized Trial of Prostate Only or Whole Pelvic RadioTherapy in High Risk Prostate Cancer (POP-RT) Trial
Source: ClinicalTrials.gov · Last updated 13 Feb 2025
Brief summary (registry, in English)
Evidence to justify the use of the pelvic field is lacking for men with high risk localized prostate cancer. An additional randomized study is needed in men with a potential risk of nodal involvement to test the hypothesis that the use of the pelvic field contributed to the benefit observed in those studies. This trial aims to compare the outcomes with whole pelvis RT and Prostate alone RT in patients with High risk, non metastatic Prostate cancer with a Lymph nodal \>20% with Primary 5 year Biochemical failure free survival and Secondary Disease free survival, overall survival, Acute toxicity, Late toxicity and QOL Patients will be randomized to one of two arms Arm 1 Whole pelvis radiotherapy and Arm 2 Prostate only radiotherapy. The Dose prescription will be 66 Gy in 25 fractions will be prescribed for the prostate PTV in Arm 2 an additional 50 Gy in 25 fractions for nodal PTV in patients in Arm 1. An overlap volume at rectal-prostate interface will receive 64 Gy/25#. All patients will receive hormone therapy starting at least 8 weeks prior to the beginning of radiotherapy. They will continue the hormone therapy and later for a total duration of 2-3 years.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 224 (actual)
- First submitted
- 24 Nov 2014
- Start date
- Nov 2011
- Primary completion date
- Aug 2017
- Lead sponsor
- Tata Memorial Centre
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT02302105
What you commit to
- Study type: Interventional
- Participants enrolled: 224
- From Nov 2011 to the primary completion date, Aug 2017
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Inclusion
- Any age according to the fitness estimated by the Physician
- Physician estimated life expectancy \> 5 years
- Biopsy proven Adenocarcinoma of prostate
- High risk prostate cancer based on Staging and Risk of Pelvic Nodal Metastases ≥ 20% as per the Roach formula (2/3 PSA) + \[(GS - 6) x 10\] If Gleason Score 8-10 - Any PSA, T1- T3a N0 M0 If Gleason Score 7 - PSA \> 15, T1-T3a N0 M0 If Gleason Score 6 - PSA \> 30, T1-T3a N0 M0 T3b-T4a N0 M0, Any Gleason Score, Any PSA
- Ability to receive long term hormone therapy/ Orchidectomy
- KPS ≥ 70 (see appendix)
- Estimated life expectancy \> 5 years
- No previous history of malignancy ≤5 years
- No prior history of therapeutic irradiation to pelvis
- Patient willing and reliable for follow-up and QOL
- No major co morbidities preventing radical treatment
- Signed study specific consent form
- Exclusion
- Any histopathology other than Adenocarcinoma
- Contraindication to Pelvic Radiotherapy like Inflammatory Bowel Disorders
- No prior history of pelvic surgery
- Uncontrolled diabetes
- Uncontrolled cardiac co morbidity
- Presence of nodal or distant metastatic disease
Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr Vedang Murthy Coordinator of this site? Confirm its status | Navi Mumbai | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.