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

Prostate Cancer Clinical Trial

— POP-RT  

Official title:

Prospective Phase III Randomized Trial of Prostate Only or Whole Pelvic RadioTherapy in High Risk Prostate Cancer (POP-RT) Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02302105
• Other study ID #: POP-RT
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 25, 2011
• Est. completion date: October 23, 2025

Study information

• Verified date: November 2021
• Source: Tata Memorial Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 224
• Est. completion date: October 23, 2025
• Est. primary completion date: October 23, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• IGRT
Image Guided RT to the prostate

Locations

Country	Name	City	State
India	Dr Vedang Murthy	Navi-Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Tata Memorial Centre

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical Disease Free Survival	Biochemical failure is defined using the standard Phoenix consensus definition i.e. PSA>2ng/ml over the nadir PSA	5 years