Prostate CancerSHARENCT03920033
Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy
A study testing Salvage radiation therapy in people with Prostate Cancer and Biochemical Recurrence, run by Asan Medical Center at 2 sites in South Korea.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Prostate Cancer, Biochemical Recurrence, Radiation
- What is being tested?
- Salvage radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 May 2019to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed intermediate- or high-risk prostate cancer
- Biochemical recurrence after radical prostatectomy (Definition: Serial elevation of PSA over 0.2 ng/mL and <=1.0 ng/mL)
- ECOG performance status 0-1
- Appropriate values of blood tests within 6 months after enrollment Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 Platelets ≥ 50,000 cells/mm3 Hemoglobin ≥ 8.0 g/dl
- Appropriate values of kidney function within 6 months after enrollment Creatinine < 2.0 ng/dL
- Appropriate values of liver function within 6 months after enrollment total bilirubin < 1.5 X maximum normal value alanine aminotransferase or aspartate aminotransferase < 2.5 X maximum normal value
Who cannot join
- Clinically gross recurrent tumor
- Presence of distant metastasis
- Presence of pelvic LN metastasis
- History of pelvic irradiation
- History of cryotherapy or brachytherapy for prostate cancer
- Double primary cancer other than skin/thyroid cancer
- Combined serious morbidity
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites, 2 recruiting
- Recruiting
Asan Medical Center
Seoul
Young Seok Kim, M.D., Ph.D., 82 2 3010 5614 ext. 5614, ysk@amc.seoul.kr
- Recruiting
Samsung Medical Center
Seoul
Won Park, M.D., Ph.D., 82-2-3410-2616, wonp68@skku.edu
About this study
Official title: Comparison of Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Recurrence After Radical Prostatectomy (SHARE Trial): a Prospective, Randomized Controlled, Open-label, Multi Center, Superiority Study
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.
- Conditions
- Prostate Cancer, Biochemical Recurrence, Radiation, Hypofractionation, Dose Escalation, Survival
- Being tested
- Salvage radiation therapy
- Medical subject headings
- Prostatic Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salvage radiation therapyRadiation
Salvage radiation therapy for biochemical recurrence
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated | Experimental | 65 Gy/ 26 fractions (fraction size 2.5 Gy) Receives: Radiation: Salvage radiation therapy |
| Standard | Active comparator | 66 Gy/ 33 fractions (fraction size 2 Gy) Receives: Radiation: Salvage radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical recurrence-free survival
PSA >0.2 ng/mLfollowed by a repeat measurement >0.2 ng/mL
Measured: 5 years
Secondary outcomes (4)
Acute toxicities
Evaulation using CTCAE 4.0 Evaluation using CTCAE 4.0 CTCAE 4.0
Measured: Adverse effects occured during radiation therapy, and within 3 months after radiation therapy
Chronic toxicities
Evaulation using CTCAE 4.0
Measured: 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.
Measured: 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.
Measured: the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start1 May 2019
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Seok Kim, Asan Medical Center
- Investigators
- Young Seok Kim, M.D., Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920033
- Sponsor's protocol ID
- S2019-0154-0001
- Acronym
- SHARE
- Status last verified
- Jan 2021
- First submitted
- 25 Mar 2019
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34674739
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Recurrence After Radical Prostatectomy (SHARE Trial): a Prospective, Randomized Controlled, Open-label, Multi Center, Superiority Study
- ClinicalTrials.gov ID
- NCT03920033
- Acronym / sponsor ID
- SHARE / S2019-0154-0001
- Conditions
- Prostate Cancer, Biochemical Recurrence, Radiation, Hypofractionation, Dose Escalation, Survival
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 18 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated | Experimental | Radiation: Salvage radiation therapy65 Gy/ 26 fractions (fraction size 2.5 Gy) |
| Standard | Active comparator | Radiation: Salvage radiation therapy66 Gy/ 33 fractions (fraction size 2 Gy) |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pathologically confirmed intermediate- or high-risk prostate cancer
- Biochemical recurrence after radical prostatectomy (Definition: Serial elevation of PSA over 0.2 ng/mL and <=1.0 ng/mL)
- ECOG performance status 0-1
- Appropriate values of blood tests within 6 months after enrollment Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 Platelets ≥ 50,000 cells/mm3 Hemoglobin ≥ 8.0 g/dl
- Appropriate values of kidney function within 6 months after enrollment Creatinine < 2.0 ng/dL
Key exclusion criteria (7 listed)
- Clinically gross recurrent tumor
- Presence of distant metastasis
- Presence of pelvic LN metastasis
- History of pelvic irradiation
- History of cryotherapy or brachytherapy for prostate cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salvage radiation therapySalvage radiation therapy for biochemical recurrence | Radiation | Hypofractionated, Standard |
Primary outcome
Biochemical recurrence-free survival
Time frame: 5 years
PSA >0.2 ng/mLfollowed by a repeat measurement >0.2 ng/mL
4 secondary outcomes
Acute toxicities
Time frame: Adverse effects occured during radiation therapy, and within 3 months after radiation therapy
Chronic toxicities
Time frame: Adverse effects occured after 3 months since end of radiation therapy
Quality of life 1
Time frame: the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years
Quality of life 2
Time frame: the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Derived from this study: PubMed 34674739Park 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Young Seok Kim, M.D., Ph.D. principal investigator
Asan Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salvage radiation therapy in people with Prostate Cancer and Biochemical Recurrence, run by Asan Medical Center at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Young Seok Kim, M.D., Ph.D. (82 2 3010 5614 ext. 5614, ysk@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical recurrence-free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03920033, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.