NCT01272050

Radiation Therapy in Treating Patients With Relapsed Prostate Cancer After Surgery

Dose Intensified Salvage Radiotherapy in Biochemically Relapsed Prostate Cancer Without Macroscopic Disease. A Randomized Phase III Trial.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Swiss Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	radiation therapy	RT in the standard arm A will be administered to a total dose of 64 Gy in 32 fractions of 2 Gy over 6.4 weeks. RT in the experimental arm B will be administered to a total dose of 70 Gy in 35 fractions of 2 Gy over 7 weeks. Megavoltage equipments with nominal photon energies ≥ 6 MV are required. Rotational techniques such as Tomotherapy®, Rapidarc®, intensity-modulated arc technique (IMAT) and volumetric-modulated arc therapy (VMAT) will also be eligible. The patient will be treated in an isocentric setting and all fields will be applied for 5 days per week for the total RT duration.

Timeline

• Start date: 2011-01-06
• Primary completion: 2020-07-03
• Completion: 2024-05-31
• First posted: 2011-01-07
• Last updated: 2024-08-28

Locations

28 sites across 3 countries: Belgium, Germany, Switzerland