Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT01272050
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.
Study:
NCT01272050
Study Brief:
Protocol Section:
NCT01272050