Randomized Trial of Prostate Only or Pelvic RT in High Risk Prostate Cancer (POP-RT)
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ClinicalTrials.gov Identifier: NCT02302105 |
Recruitment Status :
Active, not recruiting
First Posted : November 26, 2014
Last Update Posted : November 23, 2021
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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.
Condition or disease | Intervention/treatment | Phase |
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Prostate Cancer | Radiation: IGRT | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 224 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Prospective Phase III Randomized Trial of Prostate Only or Whole Pelvic RadioTherapy in High Risk Prostate Cancer (POP-RT) Trial |
Actual Study Start Date : | November 25, 2011 |
Estimated Primary Completion Date : | October 23, 2025 |
Estimated Study Completion Date : | October 23, 2025 |

Arm | Intervention/treatment |
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Active Comparator: Prostate Only
66-68 Gray (Gy) in 25 fractions will be prescribed for the prostate PTV
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Radiation: IGRT
Image Guided RT to the prostate |
Experimental: Whole Pelvis
66-68 Gray (Gy) in 25 fractions will be prescribed for the prostate PTV and 50 Gy in 25 fractions to nodal region .
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Radiation: IGRT
Image Guided RT to the prostate |
- Biochemical Disease Free Survival [ Time Frame: 5 years ]Biochemical failure is defined using the standard Phoenix consensus definition i.e. PSA>2ng/ml over the nadir PSA

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02302105
India | |
Dr Vedang Murthy | |
Navi-Mumbai, Maharashtra, India, 410210 |
Responsible Party: | Dr Vedang Murthy, Tata Memorial Centre |
ClinicalTrials.gov Identifier: | NCT02302105 |
Other Study ID Numbers: |
POP-RT |
First Posted: | November 26, 2014 Key Record Dates |
Last Update Posted: | November 23, 2021 |
Last Verified: | November 2021 |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |