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POP-RT: Randomized Trial of Prostate Only or Pelvic RT in High Risk Prostate Cancer

Sponsor
Tata Memorial Centre (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02302105
Collaborator
(none)
224
Enrollment
1
Location
2
Arms
166.9
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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
  • Radiation: IGRT
 N/A

Study Design

Study Type:
Interventional
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 :
Nov 25, 2011
Anticipated Primary Completion Date :
Oct 23, 2025
Anticipated Study Completion Date :
Oct 23, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Prostate Only

66-68 Gray (Gy) in 25 fractions will be prescribed for the prostate PTV

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 .

Radiation: IGRT
Image Guided RT to the prostate

Outcome Measures

Primary Outcome Measures

  1. Biochemical Disease Free Survival [5 years]

    Biochemical failure is defined using the standard Phoenix consensus definition i.e. PSA>2ng/ml over the nadir PSA

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No

Inclusion

  1. Any age according to the fitness estimated by the Physician

  2. Physician estimated life expectancy > 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 - 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

  5. Ability to receive long term hormone therapy/ Orchidectomy

  6. KPS ≥ 70 (see appendix)

  7. Estimated life expectancy > 5 years

  8. No previous history of malignancy ≤5 years

  9. No prior history of therapeutic irradiation to pelvis

  10. Patient willing and reliable for follow-up and QOL

  11. No major co morbidities preventing radical treatment

  12. Signed study specific consent form

Exclusion

  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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dr Vedang Murthy Navi-Mumbai Maharashtra India 410210

Sponsors and Collaborators

  • Tata Memorial Centre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr Vedang Murthy, Dr Vedang Murthy, Tata Memorial Centre
ClinicalTrials.gov Identifier:
NCT02302105
Other Study ID Numbers:
  • POP-RT
First Posted:
Nov 26, 2014
Last Update Posted:
Nov 23, 2021
Last Verified:
Nov 1, 2021
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Nov 23, 2021