Prostate CancerNCT00621413
Observation of Outcomes and Side Effects of Cesium-131 in Combination With External Beam Radiation for the Treatment of Intermediate to High Risk Prostate Cancer
An observational study of Prostate Cancer, run by IsoRay Medical, Inc. at 9 sites in United States.
Trial summary
The purpose of this study is to observe PSA response and incidence of side effects in patients diagnosed with intermediate to high risk prostate cancer and treated with Cesium-131 in combination of external beam therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- How many people
- 0 participants
- Where
- 9 sitesUnited States
- Study dates
- Feb 2007to Feb 2007
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: diagnosed patients with intermediate to high risk cancer of the prostate. Patient will be in a Radiation Oncology setting.
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate
- Clinical stage T1c - T2c (AJCC 6th Edition), NX/N0, M0
- Karnofsky Performance Score of 90 to 100
- Greater than or equal to 18 years of age
- Prostate volumes by TRUS ≤ 60 cc
- I-PSS score < 15 (alpha blockers allowed)
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- Signed study-specific informed consent form prior to study entry
- Intermediate Risk prostate cancer as determined by the following:
- Gleason sum of 7; PSA less than 10.1 ng/ml; Stage T2a or less
- Gleason sum 6 or less; PSA >10.0 and < 20.1ng/ml; Stage T2a or less
- Gleason sum 6 or less; PSA < 10.1; Stage T2b
- High risk prostate cancer as determined by the following:
- Any Gleason Sum; PSA greater than 20 ng/ml; Stage T2c or less
- Gleason Sum > 7; Any PSA; Stage T2c or less
- Any Gleason Sum; Any PSA; Stage T2c
- Any two or three intermediate risk factor
Who cannot join
- Lymph node involvement (N1)
- Evidence of distant metastases (M1)
- Any hormonal blockade or therapy that:
- Has persisted for more than 6 months by time of protocol screening; OR
- Is ongoing within 3 months of study enrollment
- Radical surgery for carcinoma of the prostate
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- Prior pelvic radiation
- Previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless disease-free for ≥ 5 years
- Major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up
- Hip prosthesis
- Inability or refusal to provide informed consent
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Sentara Cancer Institute
Hampton, Virginia, 23666
Arizona Oncology Services Foundation
Phoenix, Arizona, 85013
Eisenhower Medical Center
Rancho Mirage, California, 92270
St. Mary's Regional Medical Center
Reno, Nevada, 89503
Dorthory Schneider Cancer Center
San Mateo, California, 94401
Virginia Mason Medical Center
Seattle, Washington, 98101
Seattle Prostate Institute / Swedish Hospital
Seattle, Washington, 98104
Northshore Medical Accelerator
Smithtown, New York, 11787
Levine Cancer Center
Worcester, Massachusetts, 01605
About this study
Official title: Dosimetric and Morbidity Outcomes of Cs-131 Brachytherapy in Combination With External Beam Radiation Therapy in Subjects With Intermediate to High Risk Adenocarcinoma of the Prostate: An Observational Study
The purpose of this study is to observe PSA response and incidence of side effects in patients diagnosed with intermediate to high risk prostate cancer and treated with Cesium-131 in combination of external beam therapy.
- Conditions
- Prostate Cancer
- Keywords
- prostate, cancer, intermediate risk, high risk, brachytherapy, Cesium-131, seed brachytherapy, intermediate and high risk cancer of the prostate
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The analysis of dosimetric data resultant from Cs-131 permanent prostate brachytherapy in combination with external beam radiation therapy in the setting of intermediate to high risk cancer of the prostate.
Data collected for analysis will be total therapeutic dose delivered to the prostate by the Cs-131 brachytherapy implant treatment in units of Gy.
Measured: 5 years
Secondary outcomes (2)
The analysis of treatment related morbidities following Cs-131 prostate brachytherapy in combination with external beam therapy for intermediate to high risk cancer of the prostate.
Data collected for analysis will be the EPIC prostate cancer quality of life questionnaire.
Measured: 5 years
The analysis of PSA control rates following Cs-131 prostate brachytherapy in combination with external beam therapy for intermediate to high risk cancer of the prostate.
Data collected for analysis will be PSA measurements.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startFeb 2007 (estimated)
- Primary completionFeb 2007
- Study completionFeb 2007
Why it stopped: Study never moved forward due to no accrual
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- IsoRay Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Swedish Medical Center
- Responsible party
- Sponsor
- Investigators
- John Sylvester, MD, Principal investigator, Seattle Prostate Institute / Swedish HospitalSteve Kurtzman, MD, Principal investigator, Mills Peninsula Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621413
- Sponsor's protocol ID
- isoray_cs131_pc01
- Status last verified
- Apr 2021
- First submitted
- 12 Feb 2008
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosimetric and Morbidity Outcomes of Cs-131 Brachytherapy in Combination With External Beam Radiation Therapy in Subjects With Intermediate to High Risk Adenocarcinoma of the Prostate: An Observational Study
- ClinicalTrials.gov ID
- NCT00621413
- Acronym / sponsor ID
- isoray_cs131_pc01
- Conditions
- Prostate Cancer
- Keywords
- prostate, cancer, intermediate risk, high risk, brachytherapy, Cesium-131, seed brachytherapy, intermediate and high risk cancer of the prostate
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study never moved forward due to no accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- IsoRay Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Swedish Medical Center
- Study start
- Feb 2007 (estimated)
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 22 Feb 2008 (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 observe PSA response and incidence of side effects in patients diagnosed with intermediate to high risk prostate cancer and treated with Cesium-131 in combination of external beam therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- diagnosed patients with intermediate to high risk cancer of the prostate. Patient will be in a Radiation Oncology setting.
Key inclusion criteria (16 listed)
- Histologically confirmed adenocarcinoma of the prostate
- Clinical stage T1c - T2c (AJCC 6th Edition), NX/N0, M0
- Karnofsky Performance Score of 90 to 100
- Greater than or equal to 18 years of age
- Prostate volumes by TRUS ≤ 60 cc
Key exclusion criteria (11 listed)
- Lymph node involvement (N1)
- Evidence of distant metastases (M1)
- Any hormonal blockade or therapy that:
- Radical surgery for carcinoma of the prostate
- Prior pelvic radiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The analysis of dosimetric data resultant from Cs-131 permanent prostate brachytherapy in combination with external beam radiation therapy in the setting of intermediate to high risk cancer of the prostate.
Time frame: 5 years
Data collected for analysis will be total therapeutic dose delivered to the prostate by the Cs-131 brachytherapy implant treatment in units of Gy.
2 secondary outcomes
The analysis of treatment related morbidities following Cs-131 prostate brachytherapy in combination with external beam therapy for intermediate to high risk cancer of the prostate.
Time frame: 5 years
The analysis of PSA control rates following Cs-131 prostate brachytherapy in combination with external beam therapy for intermediate to high risk cancer of the prostate.
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
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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.
John Sylvester, MD principal investigator
Seattle Prostate Institute / Swedish Hospital
Steve Kurtzman, MD principal investigator
Mills Peninsula Hospital
9 sites 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 IsoRay Medical, Inc. at 9 sites in United States.
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 16 inclusion and 11 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: withdrawn, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
The analysis of dosimetric data resultant from Cs-131 permanent prostate brachytherapy in combination with external beam radiation therapy in the setting of intermediate to high risk cancer of the prostate. (time frame: 5 years). 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 19 Apr 2021.