Comparison of salvage hypofractionated accelerated versus salvage radiotherapy for biochemical recurrence after radical prostatectomy (SHARE trial): a prospective, randomized controlled, open-label, multi-center, superiority study

Not Applicable

Recruiting

• Conditions: Diseases of The genitoruinary system

• Registration Number: KCT0004555
• Lead Sponsor: Asan Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 14 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 288

Inclusion Criteria

Patients with histologically diagnosed prostate cancer
- Prostate cancer of medium risk groups or higher according to the National Comprehensive Cancer Network (NCCN) guidelines
- Adults over 20.
- Biochemical recurrence after surgery (Definitions: PSA >0.2 ng/mL, =1.0 ng/mL)
- Full body performance ECOG 0-1
- Finding suitable haematological examination within 6 months prior to research registration
Absolute neutrophil count (ANC) = 1500 cells/mm3
Platelets = 50,000 cells/mm3
Hemoglobin = 8.0 g/dl
- Adequate kidney function within 6 months of study registration
Creatine < 2.0 ng/dL
- Appropriate liver function within 6 months of research registration
total bilirubin < 1.5 X normal maximum
alignin aminotransferase or aspartate aminotransferase < 2.5 X normal maximum
- preSRT PSA = 1 ng/m

Exclusion Criteria

- Imaging examination of surgical site or clinically identified recurrent findings
- If pelvic lymph node transfer is confirmed
- If teleconversion is confirmed
- In case anti-cancer treatment is performed prior to surgery
- Past history of exposure to pelvic radiation
- Crucial force that has been treated for prostate cancer in cold treatment and near-field radiation
- If treated with cancer other than skin cancer and thyroid cancer, NED f/u can be registered after treatment of existing cancer for more than 5 years
- In case of severe shared disease

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PSA and Toxicity assessment are conducted every week during radiation treatment period for five years after examination and end of treatment

Secondary Outcome Measures

Name	Time	Method
Expanded prostate cancer index composite(EPIC),EORTC QLQ-C30