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

Tata Memorial Centre

Status: Active, not recruiting

Conditions: Prostate Cancer

Treatments: Radiation: IGRT

Study type: Interventional

Funder types: Other

Identifiers

NCT02302105

POP-RT

Details and patient eligibility

About

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.

Enrollment: 224 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 2 patient groups

Prostate Only

Active Comparator group

Description:

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

Treatment:

Radiation: IGRT

Whole Pelvis

Experimental group

Description:

66-68 Gray (Gy) in 25 fractions will be prescribed for the prostate PTV and 50 Gy in 25 fractions to nodal region .

Treatment:

Radiation: IGRT