Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients with a biochemical recurrence after radical prostatectomy for moderate- or high- risk prostate cancer are randomly assigned to hypofractionated, accelerated high dose radiation therapy group (65 Gy, 26 fractions) and a control group of standard treatment group (66 Gy, 33 fractions). The criteria for stratification at randomization include 1) risk groups, 2) androgen deprivation therapy, and 3) PSA before salvage radiation therapy, which affect biochemical recurrence.
It is expected that hypofractionated, accelerated high dose radiation therapy will have a superiority in terms of biochemical control to conventional radiation therapy, and the present study would like to confirm this. In addition, we aimed to evaluate and compare the toxicity and quality of life index of two radiation therapy regimens.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated | Experimental | 65 Gy/ 26 fractions (fraction size 2.5 Gy) |
|
| Standard | Active Comparator | 66 Gy/ 33 fractions (fraction size 2 Gy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salvage radiation therapy | Radiation | Salvage radiation therapy for biochemical recurrence |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical recurrence-free survival | PSA >0.2 ng/mLfollowed by a repeat measurement >0.2 ng/mL | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicities | Evaulation using CTCAE 4.0 Evaluation using CTCAE 4.0 CTCAE 4.0 | Adverse effects occured during radiation therapy, and within 3 months after radiation therapy |
| Chronic toxicities |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Young Seok Kim, M.D., Ph.D. | Contact | 82 2 3010 5614 | 5614 | ysk@amc.seoul.kr |
| Yeon Joo Kim, M.D. | Contact | 82 2 258 9243 | 9243 | kamea1004@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Young Seok Kim, M.D., Ph.D. | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34674739 | Derived | Park G, Kim YJ, Ahn H, Park W, Lee JS, Kim YS. Salvage hypofractionated accelerated versus standard radiotherapy for the treatment of biochemical recurrence after radical prostatectomy (SHARE): the protocol of a prospective, randomized, open-label, superiority, multi-institutional trial. Trials. 2021 Oct 21;22(1):728. doi: 10.1186/s13063-021-05708-5. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaulation using CTCAE 4.0
| Adverse effects occured after 3 months since end of radiation therapy |
| Quality of life 1 | Expanded prostate cancer index composite (EPIC) Questionnaire Korean version EPIC consists of 50 questions in total divided into four domains: bowel (14 questions), urinary (12 questions), sexual (13 questions), and hormonal aspects (13 questions). Scores of each domain will be separately reported. Response options for each EPIC item form a Likert scale, and multi-item scale scores will be summed and transformed linearly to a 0-to-100 scale. The higher the score, the higher the quality of life. | the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years |
| Quality of life 2 | European Organization for Research and Treatment Core Quality of Life Questionnaire (EORTC QLQ-C30) Korean version EORTC QLQ-C30 consists of 30 questions, and total score will be reported. Response options for each EPIC question form a Likert scale, and multi-item scale scores will be summed and transformed linearly to a 0-to-100 scale. The higher the score, the higher the quality of life. | the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years |
| Samsung Medical Center | Recruiting | Seoul | South Korea |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014947 | Wounds and Injuries |
Not provided
Not provided