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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02302105
Recruitment Status : Active, not recruiting
First Posted : November 26, 2014
Last Update Posted : November 23, 2021
Sponsor:
Information provided by (Responsible Party):
Dr Vedang Murthy, Tata Memorial Centre

Study Description
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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
Prostate Cancer Radiation: IGRT Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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


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

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
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Information from the National Library of Medicine

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


Locations
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India
Dr Vedang Murthy
Navi-Mumbai, Maharashtra, India, 410210
Sponsors and Collaborators
Tata Memorial Centre
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases