Radiation Therapy in Treating Patients With Relapsed Prostate Cancer After Surgery
- Conditions
- Prostate Cancer
- Interventions
- Radiation: radiation therapy
- Registration Number
- NCT01272050
- Lead Sponsor
- Swiss Group for Clinical Cancer Research
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating patients with relapsed prostate cancer.
PURPOSE: This randomized phase III trial is studying the side effects of radiation therapy and comparing two radiation therapy regimens in treating patients with relapsed prostate cancer after surgery.
- Detailed Description
OBJECTIVES:
* To determine the tumor control in patients with biochemically relapsed prostate cancer without macroscopic disease treated with dose-intensive salvage radiotherapy.
* To determine the toxicity in these patients.
* To determine the quality of life of these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (≥ 8 vs 7 vs ≤ 6), pathological tumor classification (pT3b vs others), lymphadenectomy performed (yes \[pN0\] vs no \[cN0\]), persistent PSA after prostatectomy (detectable \[≥ 0.1 ng/mL\] vs undetectable \[\< 0.1 ng/mL\]), PSA at randomization (\> 0.5 ng/mL vs ≤ 0.5 ng/mL), participating center, and radiotherapy technique (3-dimensional conformal radiation therapy \[3D-CRT\] vs intensity-modulated radiation therapy \[IMRT\]/rotational techniques). Patient are randomized to 1 of 2 treatment arms.
* Arm A: Beginning at least 12 weeks after surgery, patients undergo radiotherapy\* once a day, 5 days a week, for 6.4 weeks for a total dose of 64 Gy (in 32 fractions of 2 Gy over 6.4 weeks).
* Arm B: Patients undergo radiotherapy\* once a day, 5 days a week, for 7 weeks for a total dose of 70 Gy (in 35 fractions of 2 Gy over 7 weeks).
NOTE: \*3-dimensional conformal radiation therapy, rotational techniques such as Tomotherapy®, Rapidarc®, or intensity-modulated arc technique and volumetric-modulated arc therapy are all eligible.
Patients complete quality-of-life questionnaires at baseline and at 3, 12, 24, 36, 48, and 60 months after completing study therapy.
After completion of study treatment, patients are followed every 6 months for 3 years and then every 12 months for up to 10 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 350
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Arm B: 70 Gy - Radiation Therapy radiation therapy Arm B: 70 Gy (35 x 2 Gy) without hormonal treatment Arm A: 64 Gy - Radiation Therapy radiation therapy Arm A: 64 Gy (32 x 2 Gy) without hormonal treatment
- Primary Outcome Measures
Name Time Method Freedom from biochemical progression from the day of trial randomization to the day of either first recorded biochemical progression, clinical progression or death due to clinical progression up to 10 years.
- Secondary Outcome Measures
Name Time Method Prostate cancer-specific survival time from trial randomization to the date of death due to prostate cancer up to 10 years. Overall survival time from trial randomization to the date of death from any cause up to 10 years. Clinical progression-free survival from the day of randomization to the day of the first record of either local or regional recurrence, distant recurrence, start of hormonal treatment, or death due to any cause up to 10 years. Time to hormonal treatment time from trial randomization to start of hormonal treatment up to 10 years. Acute and late gastrointestinal and genitourinary toxicity according to CTCAE v 4.0 occurring during treatment and up to 3 months after completion of treatment. Late toxicity is defined as occurring later than 3 months after end of treatment.
Trial Locations
- Locations (28)
Ziekenhuis Netwerk Antwerpen Middelheim
🇧🇪Antwerpen, Belgium
Ghent University Hospital
🇧🇪Ghent, Belgium
University Hospital and Medical Faculty Technical University of Dresden
🇩🇪Dresden, Germany
Charite University Hospital - Campus Virchow Klinikum
🇩🇪Berlin, Germany
Universitaetsklinikum Aachen, Klinik für Strahlentherapie
🇩🇪Aachen, Germany
Universitaetsklinikum Essen, Klinik für Strahlentherapie
🇩🇪Essen, Germany
Klinikum der LMU Muenchen
🇩🇪Munich, Germany
Universitätsklinikum Saarland
🇩🇪Homburg, Germany
Technische Universitaet Muenchen
🇩🇪Munich, Germany
Klinikum der Universitaet Regensburg
🇩🇪Regensburg, Germany
Klinik fuer Strahlentherapie Universitaet Wuerzburg
🇩🇪Wuerzburg, Germany
Universitaet Tuebingen
🇩🇪Tuebingen, Germany
Klinik und Poliklinik fuer Strahlentherapie - Universitaetsklinikum Rostock
🇩🇪Rostock, Germany
Kantonsspital Aarau
🇨🇭Aarau, Switzerland
Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli
🇨🇭Bellinzona, Switzerland
Inselspital Bern
🇨🇭Bern, Switzerland
Radio-Onkologiezentrum Biel-Seeland-Berner Jura AG
🇨🇭Biel, Switzerland
Kantonsspital Luzern
🇨🇭Luzern, Switzerland
Kantonsspital - St. Gallen
🇨🇭St. Gallen, Switzerland
Hopital de Sion
🇨🇭Sion, Switzerland
City Hospital Triemli
🇨🇭Zurich, Switzerland
UniversitaetsSpital Zuerich
🇨🇭Zurich, Switzerland
Universitaetsspital-Basel
🇨🇭Basel, Switzerland
Kantonsspital Graubuenden
🇨🇭Chur, Switzerland
Kantonsspital Muensterlingen
🇨🇭Münsterlingen, Switzerland
St. Lukas Hospital Ghent
🇧🇪Ghent, Belgium
Klinik Hirslanden
🇨🇭Zurich, Switzerland
Radio-Onkologie Berner Oberland AG
🇨🇭Thun, Switzerland