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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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0004555
Enrollment
288
Registered
2019-12-16
Start date
2019-08-02
Completion date
Unknown
Last updated
2020-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Radiation : Equivalent dose in 2 Gy irradiation using linear-quadratic model [surviving fraction = exp-1(aD + ßD2)] is mainly used to compare the relative doses between radiation treatments of various

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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/mL

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
PSA and Toxicity assessment are conducted every week during radiation treatment period for five years after examination and end of treatment

Secondary

MeasureTime frame
Expanded prostate cancer index composite(EPIC),EORTC QLQ-C30

Countries

Korea, Republic of

Contacts

Public ContactKim Seok

Asan Medical Center

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026