A clinical trial to study the effects of radiotherapy on Prostate Only or whole Pelvic region in high risk prostate cancer patients. (POP-RT) trial

Prospective Phase III Randomized trial of Prostate Only or whole Pelvic RadioTherapy in high risk prostate cancer (POP-RT) trial - POP-RT trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/12/003181

Enrollment

224

Registered

2012-12-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- prostate cancer

Interventions

Intervention1: Radiotherapy to whole pelvis: 66-68 Gray (Gy) in 25 fractions will be prescribed for the prostate PTV for all patients in both arms and 50 Gy in 25 fractions for nodal PTV in patients i

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion 1. Age 18 to 75 years 2 Physician estimated life expectancy more than 5 years 3. Biopsy proven Adenocarcinoma of prostate 4. High risk prostate cancer based on Staging and Risk of Pelvic Nodal Metastases 20% as per the Roach formula (2/3 PSA) + [(GS â?? 6) x 10] 4. If Gleason Score 8-10 with Any PSA, T1- T3a N0 M0 5. If Gleason Score 7 with PSA more than 15 T1-T3a N0 M0 6. If Gleason Score 6 with PSA more than 30 T1-T3a N0 M0 7. T3b-T4a N0 M0 Any Gleason Score Any PSA 8. Ability to receive long term hormone therapy/ orchidectomy 9. KPS moretha 70 (see appendix) 10. Estimated life expectancy more than 5 years 11. No previous history of malignancy 12. No prior history of therapeutic irradiation to pelvis 13. Patient willing and reliable for follow-up and QOL 14. No major co morbidities preventing radical treatment 15. Signed study specific consent form

Exclusion criteria

Exclusion criteria: 1. Any histopathology other than Adenocarcinoma 2. Contraindication to Pelvic Radiotherapy like Inflammatory Bowel Disorders 3. No prior history of pelvic surgery 4. Uncontrolled diabetes 5. Uncontrolled cardiac co morbidity 6. Presence of nodal or distant metastatic disease

Design outcomes

Primary

Measure	Time frame
o 4 year Biochemical Failure Free (BFF) survivalTimepoint: o 4 year Biochemical Failure Free (BFF) survival	—

Secondary

Measure	Time frame
o Disease Free Survival (DFS) o Overall Survival o Acute Toxicity o Late toxicity o QOLTimepoint: 4 years	—

Countries

India

Contacts

Public ContactVedang Murthy

Tata memorial Centre- ACTREC

vmurthy@actrec.gov.in27405510

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026