Prostate NeoplasmPhase 3NCT03241537
COHORT Trial in Clinical Pelivc Lymph Node Metastatic Prostate Cancer
A Phase 3 study testing Intensity modulated radiotherapy in people with Prostate Neoplasm, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
In local advanced prostate cancer patients with clinically positive metastatic regional lymph node, the optimal treatment is still unanswered. For these patients, radiotherapy combined with hormonal therapy or hormonal therapy alone are recommended. Read more about this study
- Who is it for?
- Ages 20 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Neoplasm
- What is being tested?
- Intensity modulated radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jan 2016to 14 Dec 2026
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- pathologically confirmed prostate cancer within 6 months for study enrollment
- Clincally enlarged pelvic lymph node ((short axis 0.5 cm ≤) in imaging studies (CT, MRI, PET-CT) at diagnosis and partial response or complete remission of enlarged lymph nodes according to RECIST v1.1 after hormonal therapy for 2-3 months 3. age 20 ≤ 4. ECOG performance status 0-1 5. Optimal hematologic profiles within 6 months for study enrollment
- Absolute neutrophil count (ANC) ≥ 1500 cells/mm3
- Platelets ≥ 50,000 cells/mm3
- Hemoglobin ≥ 8.0 g/dl 6. Optimal kidney function within 6 months for study enrollment
- Creatinine < 2.0 ng/dL 7. Optimal liver functions within 6 months for study enrollment
- total bilirubin < 1.5 X maximum normal value
- alanine aminotransferase or aspartate aminotransferase < 2.5 X maximum normal value
Who cannot join
- combined with distant metastasis (retroperitoneal lymph node, bone,...)
- previous history of antiandrogen therapy within 6 months of study enrollment
- previous history of definitive prostate cancer treatment such as prostatectomy
- previous history of pelvic radiotherapy
- previous history of other cancer treatment except for skin cancer and theroid cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Randomized Phase III Trial of Hormone Therapy Alone Versus COmbined HOrmone With Radiation Therapy in Clinical Pelvic Lymph Node Metastatic Prostate Cancer (COHORT Trial)
In local advanced prostate cancer patients with clinically positive metastatic regional lymph node, the optimal treatment is still unanswered. For these patients, radiotherapy combined with hormonal therapy or hormonal therapy alone are recommended. Recently, the reports from NCCB and SEER data showed that radiotherapy combined with hormonal therapy have better survivals than hormonal therapy alone.
This randomized phase III trial compare hormonal therapy alone with combined hormone with radiotherapy in clinically pelvic lymph node metastatic prostate cancer.
- Conditions
- Prostate Neoplasm
- Being tested
- Intensity modulated radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity modulated radiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Hormonal therapy alone | No intervention | total androgen ablation or antiandrogen therapy alone for 2-3 years |
| Hormonal therapy with radiotherapy | Active comparator | total androgen ablation or antiandrogen therapy for 2-3 years combined with radiotherapy on whole pelvis Receives: Radiation: Intensity modulated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of recurrence-free survival between two treatment groups
expected 5-year recurrence-free survival were 40% in hormonal therapy alone group and more than 80% in hormonal therapy combined with radiotherapy
Measured: 5-year
Secondary outcomes (5)
Comparison of toxicities between two treatment groups
Compare adverse events accroding to CTCAE V4.0 between hormonal therapy alone group and hormonal therapy combined with radiotherapy group
Measured: 5-year
Comparison of quality of lifl between two treatment groups
Compare quality of life accroding to Expanded prostate cancer index composite_Korean between hormonal therapy alone group and hormonal therapy combined with radiotherapy group
Measured: 5-year
Comparison of overall survival between two treatment groups
Compare overall survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group
Measured: 5-year
Comparison of clinical failure free survival between two treatment groups
Compare clinical failure free survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group
Measured: 5-year
Comparison of cause-specific survival between two treatment groups
Compare cause-specific survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group
Measured: 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start15 Jan 2016
- Primary completion14 Dec 2026 (estimated)
- Study completion14 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate NeoplasmStudies of the same condition, open and under way.
- More trials run by Samsung 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Won Park, M.D.,Ph.D, Principal investigator, Korean Radiation Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241537
- Sponsor's protocol ID
- SMC2015-11-139-002
- Status last verified
- Nov 2023
- First submitted
- 27 Jul 2017
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Randomized Phase III Trial of Hormone Therapy Alone Versus COmbined HOrmone With Radiation Therapy in Clinical Pelvic Lymph Node Metastatic Prostate Cancer (COHORT Trial)
- ClinicalTrials.gov ID
- NCT03241537
- Acronym / sponsor ID
- SMC2015-11-139-002
- Conditions
- Prostate Neoplasm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- 14 Dec 2026 (estimated)
- Study completion
- 14 Dec 2026 (estimated)
- First posted
- 7 Aug 2017 (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.
In local advanced prostate cancer patients with clinically positive metastatic regional lymph node, the optimal treatment is still unanswered. For these patients, radiotherapy combined with hormonal therapy or hormonal therapy alone are recommended. Recently, the reports from NCCB and SEER data showed that radiotherapy combined with hormonal therapy have better survivals than hormonal therapy alone.
This randomized phase III trial compare hormonal therapy alone with combined hormone with radiotherapy in clinically pelvic lymph node metastatic prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hormonal therapy alone | No intervention | –total androgen ablation or antiandrogen therapy alone for 2-3 years |
| Hormonal therapy with radiotherapy | Active comparator | Radiation: Intensity modulated radiotherapytotal androgen ablation or antiandrogen therapy for 2-3 years combined with radiotherapy on whole pelvis |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- pathologically confirmed prostate cancer within 6 months for study enrollment
- Clincally enlarged pelvic lymph node ((short axis 0.5 cm ≤) in imaging studies (CT, MRI, PET-CT) at diagnosis and partial response or complete remission of enlarged lymph nodes according to RECIST v1.1 after hormonal therapy for 2-3 months 3. age 20 ≤ 4. ECOG performance status 0-1 5. Optimal hematologic profiles within 6 months for study enrollment
- Absolute neutrophil count (ANC) ≥ 1500 cells/mm3
- Platelets ≥ 50,000 cells/mm3
- Hemoglobin ≥ 8.0 g/dl 6. Optimal kidney function within 6 months for study enrollment
Key exclusion criteria (5 listed)
- combined with distant metastasis (retroperitoneal lymph node, bone,...)
- previous history of antiandrogen therapy within 6 months of study enrollment
- previous history of definitive prostate cancer treatment such as prostatectomy
- previous history of pelvic radiotherapy
- previous history of other cancer treatment except for skin cancer and theroid 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 |
|---|---|---|
| Intensity modulated radiotherapy | Radiation | Hormonal therapy with radiotherapy |
Primary outcome
Comparison of recurrence-free survival between two treatment groups
Time frame: 5-year
expected 5-year recurrence-free survival were 40% in hormonal therapy alone group and more than 80% in hormonal therapy combined with radiotherapy
5 secondary outcomes
Comparison of toxicities between two treatment groups
Time frame: 5-year
Comparison of quality of lifl between two treatment groups
Time frame: 5-year
Comparison of overall survival between two treatment groups
Time frame: 5-year
Comparison of clinical failure free survival between two treatment groups
Time frame: 5-year
Comparison of cause-specific survival between two treatment groups
Time frame: 5-year
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 27 Nov 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Won Park, M.D.,Ph.D principal investigator
Korean Radiation Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intensity modulated radiotherapy in people with Prostate Neoplasm, run by Samsung Medical Center at 1 site 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 8 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of recurrence-free survival between two treatment groups (time frame: 5-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2023.