Prostate CancerSHIP36BNCT00898326
PSA Levels and Biopsy Samples After Implant Radiation and Hormone Therapy in Patients With Stage I or Stage II Prostate Cancer
An observational study of Prostate Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
Trial summary
RATIONALE: Studying samples of blood and tissue from patients with prostate cancer after receiving implant radiation therapy and luteinizing hormone-releasing hormone agonist may help doctors identify biomarkers related to cancer and help doctors predict how patients will respond to treatment. Read more about this study
- Who is it for?
- Ages 20 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- biopsy
- How many people
- 198 participants
- Where
- 1 siteJapan
- Study dates
- 1 Apr 2011to 31 Dec 2016
- Phase
- Observational
- 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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Previously enrolled on protocol JUSMH-BRI-GU05-01 and 36 month after treatement of brachytherapy.
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed prostate cancer
- Previously untreated disease prior to participation on protocol JUSMH-BRI-GU05-01
- Intermediate-risk disease as defined by the following:
- Clinical stage < T2c
- Prostate-specific antigen (PSA) ≤ 20 ng/mL
- Gleason score < 8
- Previously enrolled on protocol JUSMH-BRI-GU05-01
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 3 months
- WBC ≥ 2,000/μL
- Hemoglobin ≥ 10.0 g/dL
- Platelet count ≥ 100,000/μL
- Serum creatine level ≤ 2.0 mg/dL
- ALT and AST ≤ 100 IU/L
- No other cancer requiring treatment
- No poorly controlled hypertension (i.e., diastolic blood pressure ≥ 120 mm Hg)
- No severe psychiatric disorders, including schizophrenia or dementia
- No poorly controlled diabetes
- Considered appropriate for study participation, as determined by the Principal Investigator or Clinical Investigator
PRIOR CONCURRENT THERAPY:
- No prior drugs for benign prostatic hyperplasia (other than antiandrogen therapy)
- No prior surgery for prostate cancer
- No concurrent steroid drugs (except for ointment)
- No other concurrent antiandrogen therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Biopsy Results at 36 Months After Permanent I-125 Implantation Therapy Plus LHRH-agonist Therapy for Patients With Untreated Intermediate Prostate Cancer.
RATIONALE: Studying samples of blood and tissue from patients with prostate cancer after receiving implant radiation therapy and luteinizing hormone-releasing hormone agonist may help doctors identify biomarkers related to cancer and help doctors predict how patients will respond to treatment.
PURPOSE: This laboratory study is looking at PSA levels and biopsy samples after undergoing implant radiation therapy and luteinizing hormone-releasing hormone agonist therapy in patients with stage I or stage II prostate cancer.
Read the detailed description
OBJECTIVES:
- To analyze biopsy results at 36 months after permanent iodine I 125 implantation therapy and luteinizing hormone-releasing hormone (LHRH) agonist therapy for patients with untreated intermediate-risk prostate cancer.
OUTLINE: Patients received luteinizing hormone releasing-hormone (LHRH) agonist therapy and permanent iodine I 125 implantation on protocol JUSMH-BRI-GU05-01.
Patients undergo blood sample collection and tissue biopsy for biomarker/laboratory analysis at 36 months after receiving brachytherapy and releasing-hormone agonist therapy. PSA levels and biopsy results are compared.
- Conditions
- Prostate Cancer
- Being tested
- biopsy
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsyOther
Conduct prostatic needle biopsy at 36-39 months-after brachy therapy. Basic method is by transectal ultra-sound-guided systematic biopsy,; systematic sextant biopsy which involves samples from both seminal vesicles is adopted as much as possible.
| Study group | Role | What they receive |
|---|---|---|
| Biopsy 36 month after breacchytherapy | Biopsy 36 month after breacchytherapy on protocol JUSMH-BRI-GU05-01. Receives: Other: biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of PSA levels and biopsy results at 36 months months
Compare biobsy results and PSA revels at baseline vs. 36 months after brachytherapy.
Measured: 36-39 month after PI-125
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study start1 Apr 2011
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Jikei University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Shin Egawa, MD, PhD, Principal investigator, Jikei University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898326
- Sponsor's protocol ID
- JUSMH-TRIGU0709
- Other IDs
- CDR0000593698
- Acronym
- SHIP36B
- Status last verified
- Jun 2017
- First submitted
- 9 May 2009
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Miki K, Kiba T, Sasaki H, Kido M, Aoki M, Takahashi H, Miyakoda K, Dokiya T, Yamanaka H, Fukushima M, Egawa S. Transperineal prostate brachytherapy, using I-125 seed with or without adjuvant androgen deprivation, in patients with intermediate-risk prostate cancer: study protocol for a phase III, multicenter, randomized, controlled trial. BMC Cancer. 2010 Oct 21;10:572. doi: 10.1186/1471-2407-10-572.
PubMed 20964826
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Biopsy Results at 36 Months After Permanent I-125 Implantation Therapy Plus LHRH-agonist Therapy for Patients With Untreated Intermediate Prostate Cancer.
- ClinicalTrials.gov ID
- NCT00898326
- Acronym / sponsor ID
- SHIP36B / JUSMH-TRIGU0709
- Conditions
- Prostate Cancer
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Jikei University School of Medicine
- Study start
- 1 Apr 2011 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 12 May 2009 (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.
RATIONALE: Studying samples of blood and tissue from patients with prostate cancer after receiving implant radiation therapy and luteinizing hormone-releasing hormone agonist may help doctors identify biomarkers related to cancer and help doctors predict how patients will respond to treatment.
PURPOSE: This laboratory study is looking at PSA levels and biopsy samples after undergoing implant radiation therapy and luteinizing hormone-releasing hormone agonist therapy in patients with stage I or stage II prostate cancer.
Detailed description
OBJECTIVES:
- To analyze biopsy results at 36 months after permanent iodine I 125 implantation therapy and luteinizing hormone-releasing hormone (LHRH) agonist therapy for patients with untreated intermediate-risk prostate cancer.
OUTLINE: Patients received luteinizing hormone releasing-hormone (LHRH) agonist therapy and permanent iodine I 125 implantation on protocol JUSMH-BRI-GU05-01.
Patients undergo blood sample collection and tissue biopsy for biomarker/laboratory analysis at 36 months after receiving brachytherapy and releasing-hormone agonist therapy. PSA levels and biopsy results are compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biopsy 36 month after breacchytherapy | – | Other: biopsyBiopsy 36 month after breacchytherapy on protocol JUSMH-BRI-GU05-01. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Previously enrolled on protocol JUSMH-BRI-GU05-01 and 36 month after treatement of brachytherapy.
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 |
|---|---|---|
| biopsyConduct prostatic needle biopsy at 36-39 months-after brachy therapy. Basic method is by transectal ultra-sound-guided systematic biopsy,; systematic sextant biopsy which involves samples from both seminal vesicles is adopted as much as possible. | Other | Biopsy 36 month after breacchytherapy |
Primary outcome
Comparison of PSA levels and biopsy results at 36 months months
Time frame: 36-39 month after PI-125
Compare biobsy results and PSA revels at baseline vs. 36 months after brachytherapy.
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 2 Jun 2017.
- Results publication: PubMed 20964826Miki K, Kiba T, Sasaki H, Kido M, Aoki M, Takahashi H, Miyakoda K, Dokiya T, Yamanaka H, Fukushima M, Egawa S. Transperineal prostate brachytherapy, using I-125 seed with or without adjuvant androgen deprivation, in patients with intermediate-risk prostate cancer: study protocol for a phase III, multicenter, randomized, controlled trial. BMC Cancer. 2010 Oct 21;10:572. doi: 10.1186/1471-2407-10-572.
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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.
Shin Egawa, MD, PhD principal investigator
Jikei University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 2 Jun 2017. 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 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.
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?
Comparison of PSA levels and biopsy results at 36 months months (time frame: 36-39 month after PI-125). 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 NCT00898326, 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 2 Jun 2017; AzTrials last refreshed its copy on 7 Nov 2026.