Prostate CancerPhase 3NCT00138008
Trial to Evaluate Radiotherapy Followed by Endocrine Therapy Vs Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy
A Phase 3 study testing endocrine therapy and radiotherapy in people with Prostate Cancer, run by Haruhiko Fukuda at 34 sites in Japan.
Trial summary
The purpose of this study is to evaluate radiotherapy followed by endocrine therapy in comparison with endocrine therapy alone for PSA failure after radical prostatectomy. Read more about this study
- Who is it for?
- Ages 20 to 79 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- endocrine therapy and radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 34 sitesJapan
- Study dates
- May 2004to May 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of localized prostate cancer (clinical stage T1-2N0M0) which is treated by radical prostatectomy
- Pathological stage: pT0/2/3 and pN0/x
- Serum level of PSA once reached < 0.1 ng/ml after radical prostatectomy and then increased 0.4 ng/ml
- Serum level of PSA 1.0 ng/ml at entry
- No clinical recurrence based on abdominal and pelvic computed tomography, and a bone scan
- No history of chemotherapy or radiation therapy or endocrine therapy for any cancer
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- Ages 20 to 79 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- No blood transfusion within 28 days of entry
- Sufficient organ function within 28 days of entry
- Provided written informed consent
Who cannot join
- Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
- Mental disease or mental symptoms which would affect participant's decision to participate
- Continuous medication with steroids (exclude external use of steroids for skin)
- Ischemic heart disease or arrhythmia which needs medical treatment
- Poorly controlled hypertension
- Poorly controlled diabetes mellitus
Show all 9Show fewer
- History of cerebral infarction or myocardial infarction within 6 months
- Liver cirrhosis
- Interstitial pneumonia which requires ventilation assistance, oxygen inhalation, steroids, or diuretic medicine
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
Japan34 sites
Akita University School of Medicine
Akita,Hondo,1-1-1, Akita, 010-8543
Chiba University, Graduate School of Medicine
Chiba,Chuo-ku,Inohana,1-8-1, Chiba, 260-8670
Chiba Cancer Center Hospital
Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, 260-8717
National Cancer Center Hospital
Chuo-ku,Tsukiji,5-1-1, Tokyo, 104-0045
Graduate School of Medical Science, Kyushu University
Fukuoka, Higashi-ku,Maidashi,3-1-1, Fukuoka, 812-8582
Hamamatsu University School of Medicine
Hamamatsu,Handayama,1-20-1, Shizuoka, 431-3192
Shimane University Faculty of Medicine
Izumo,Enya-cho,89-1, Shimane, 693-8501
Kagoshima University,Faculty of Medicine
Kagoshima,Sakuragaoka,8-35-1, Kagoshima-ken, 890-8520
Nara Medical University
Kashihara,Shijo-cho,840, Nara, 634-8522
Faculty of Medicine, Kagawa University
Kita,Miki-cho,Ikenobe,1750-1, Kagawa-ken, 761-0793
Kobe University Graduate School of Medicine
Kobe,Chuo-ku,Kusunoki-cho,7-5-2, Hyōgo, 650-0017
Kurashiki Central Hospital
Kurashiki,Miwa,1-1-1, Okayama-ken, 710-8602
Kurume University School of Medicine
Kurume,Asahi-machi,67, Fukuoka, 830-0011
Kyoto University Hospital
Kyoto,Sakyo-ku,Syogoinkawara,54, Kyoto, 606-8507
Gunma University
Maebashi,Showa,3-39-15, Gunma, 371-8511
Sinshu University
Matsumoto,Asahi,3-1-1, Nagano, 390-8621
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, 790-0007
Jikei University Hospital
Minato-ku,Nishishinbashi,3-25-8, Tokyo, 105-8461
Nagoya University School of Medicine
Nagoya,Showa-ku,Tsurumai-cho,65, Aichi-ken, 466-8550
University of Yamanashi Faculty of Medicine
Nakakoma,Tamaho,Shimokato,1110, Yamanashi, 409-3898
Miyagi Cancer Center
Natori,Medeshima-Shiode,Nodayama,47-1, Miyagi, 981-1293
Niigata University Medical and Dental Hospital
Niigata,Asahimachi-dori,1-754, Niigata, 951-8520
Niigata Cancer Center Hospital
Niigata,Kawagishi-cho,2-15-3, Niigata, 951-8566
Hokkaido University Hospital
North-14 West-5 Kita-ku,Sapporo, Hokkaido, 060-8648
Okayama University Hospital
Okayama,Shikata-cho,2-5-1, Okayama-ken, 700-8558
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, 537-8511
Sapporo Medical University
S-1,W-16,Chuo-ku,Sapporo, Hokkaido, 060-8543
Kitasato University School of Medicine
Sagamihara,Kitasato,1-15-1, Kanagawa, 228-8555
Tohoku University Hospital
Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, 980-8574
Keio University Hospital
Shinjuku-ku,Shinanomachi,35, Tokyo, 160-8582
Sizuoka Cancer Center
Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, 411-8777
Mie University School of Medicine
Tsu,Edobashi,2-174, Mie-ken, 514-8507
Institute of Clinical Medicine,Tsukuba University Hospital
Tsukuba,Tennodai,1-1-1, Ibaraki, 305-8575
Tochigi Cancer Center
Utsunomiya,Yohnan,4-9-13, Tochigi, 320-0834
About this study
Official title: Randomized Controlled Trial to Evaluate Radiotherapy Followed by Endocrine Therapy vs. Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy (JCOG0401)
The purpose of this study is to evaluate radiotherapy followed by endocrine therapy in comparison with endocrine therapy alone for PSA failure after radical prostatectomy.
Read the detailed description
A randomized controlled trial is conducted in Japan to evaluate radiotherapy followed by endocrine therapy for PSA failure after radical prostatectomy. Patients who have PSA failure after radical prostatectomy under a diagnosis of localized prostate cancer (T1-2 N0M0) are randomized into treatment group of either radiotherapy followed by endocrine therapy or endocrine therapy alone. Urologic Oncology Study Group (UOSG) in the JCOG composed of 36 specialized institutions will recruit 200 patients. The primary endpoint is time to treatment failure (TTF) of bicalutamide and secondary endpoints are TTF of protocol treatment, progression free survival, overall survival, adverse events and quality of life (QOL). The Clinical Trial Review Committee of the Japan Clinical Oncology Group (JCOG) approved the protocol on April 13, 2004, and the study was activated on May 17, 2004.
- Conditions
- Prostate Cancer
- Being tested
- endocrine therapy, radiotherapy
- Keywords
- prostate cancer, radical prostatectomy, PSA failure, RCT, radiation, endocrinotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endocrine therapyDrug
Drug: endocrine therapy
radiotherapyProcedure or surgery
Procedure/Surgery: radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Drug: endocrine therapy Receives: Drug: endocrine therapy |
| 2 | Experimental | Procedure/Surgery: radiotherapy Receives: Procedure: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to treatment failure (TTF) of bicalutamide
Measured: time to treatment failure (TTF) of bicalutamide
Secondary outcomes (5)
TTF of protocol treatment
Measured: TTF of protocol treatment
clinical progression free survival
Measured: time to clinical progression
overall survival
Measured: overall
adverse events
Measured: overall
patient-reported quality of life
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startMay 2004
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haruhiko Fukuda
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Responsible party
- Sponsor-investigator, Haruhiko Fukuda, Japan Clinical Oncology Group
- Investigators
- Seiji Naito, MD, Ph.D., Study chair, Graduate School of Medical Science, Kyushu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138008
- Sponsor's protocol ID
- JCOG0401
- Other IDs
- C000000026
- Status last verified
- Sep 2016
- First submitted
- 29 Aug 2005
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate Radiotherapy Followed by Endocrine Therapy vs. Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy (JCOG0401)
- ClinicalTrials.gov ID
- NCT00138008
- Acronym / sponsor ID
- JCOG0401
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, radical prostatectomy, PSA failure, RCT, radiation, endocrinotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Haruhiko FukudaUniversity, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Study start
- May 2004
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 30 Aug 2005 (estimated)
- 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.
The purpose of this study is to evaluate radiotherapy followed by endocrine therapy in comparison with endocrine therapy alone for PSA failure after radical prostatectomy.
Detailed description
A randomized controlled trial is conducted in Japan to evaluate radiotherapy followed by endocrine therapy for PSA failure after radical prostatectomy. Patients who have PSA failure after radical prostatectomy under a diagnosis of localized prostate cancer (T1-2 N0M0) are randomized into treatment group of either radiotherapy followed by endocrine therapy or endocrine therapy alone. Urologic Oncology Study Group (UOSG) in the JCOG composed of 36 specialized institutions will recruit 200 patients. The primary endpoint is time to treatment failure (TTF) of bicalutamide and secondary endpoints are TTF of protocol treatment, progression free survival, overall survival, adverse events and quality of life (QOL). The Clinical Trial Review Committee of the Japan Clinical Oncology Group (JCOG) approved the protocol on April 13, 2004, and the study was activated on May 17, 2004.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: endocrine therapyDrug: endocrine therapy |
| 2 | Experimental | Procedure: radiotherapyProcedure/Surgery: radiotherapy |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- A diagnosis of localized prostate cancer (clinical stage T1-2N0M0) which is treated by radical prostatectomy
- Pathological stage: pT0/2/3 and pN0/x
- Serum level of PSA once reached < 0.1 ng/ml after radical prostatectomy and then increased 0.4 ng/ml
- Serum level of PSA 1.0 ng/ml at entry
- No clinical recurrence based on abdominal and pelvic computed tomography, and a bone scan
Key exclusion criteria (9 listed)
- Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
- Mental disease or mental symptoms which would affect participant's decision to participate
- Continuous medication with steroids (exclude external use of steroids for skin)
- Ischemic heart disease or arrhythmia which needs medical treatment
- Poorly controlled hypertension
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 |
|---|---|---|
| endocrine therapyDrug: endocrine therapy | Drug | 1 |
| radiotherapyProcedure/Surgery: radiotherapy | Procedure or surgery | 2 |
Primary outcome
time to treatment failure (TTF) of bicalutamide
Time frame: time to treatment failure (TTF) of bicalutamide
5 secondary outcomes
TTF of protocol treatment
Time frame: TTF of protocol treatment
clinical progression free survival
Time frame: time to clinical progression
overall survival
Time frame: overall
adverse events
Time frame: overall
patient-reported quality of life
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
- Related InfoLink provided by the sponsor.
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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.
Seiji Naito, MD, Ph.D. study chair
Graduate School of Medical Science, Kyushu University
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing endocrine therapy and radiotherapy in people with Prostate Cancer, run by Haruhiko Fukuda at 34 sites in Japan.
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 11 inclusion and 9 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: finished, as of the sponsor's last update on 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
time to treatment failure (TTF) of bicalutamide (time frame: time to treatment failure (TTF) of bicalutamide). 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 22 Sep 2016.