Prostate CancerNCT00681694
Long-Term Outcomes of Alternative Brachytherapy Techniques for Early Prostate Cancer
An observational study of Prostate Cancer, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
The purpose of this research study is to assess outcomes of treatment for early prostate cancer. Current treatments for early (non-metastatic) cancer may cause long-term impairments in the patients quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- brachytherapy
- Type of treatment
- Surgery or procedure
- How many people
- 414 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2002to Mar 2011
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have indicated their intention to receive brachytherapy at one of the four accrual sites.
Who may be able to join
- Pathological diagnosis of an adenocarcinoma of the prostate
- 18 years of age or older
- Prior choice of either standard brachytherapy or MRIGPB as primary treatment
Who cannot join
- Prior primary therapy (surgery or external beam radiation) for prostate cancer
- Current hormone ablation therapy
Trial locations and contacts
3 sites in 1 country.
Anita Rodrigues contact
United States3 sites, 3 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
James Talcott, MD, SM
- Recruiting
Dana-Farber Cancer Institute/Brigham and Women's Hospital
Boston, Massachusetts, 02115
Anthony D'Amico, MD
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Irving Kaplan, MD
About this study
The purpose of this research study is to assess outcomes of treatment for early prostate cancer. Current treatments for early (non-metastatic) cancer may cause long-term impairments in the patients quality of life. In this study we will compare the outcomes of patients treated with two alternative brachytherapy (seed implants) techniques using a series of questionnaires.
Read the detailed description
Participants will be asked to complete a questionnaire about their health prior to treatment, at 1, 3 and 12 months after treatment and then once a year 4 more times.
- Conditions
- Prostate Cancer
- Being tested
- brachytherapy
- Keywords
- brachytherapy, radioactive seed implants
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brachytherapyRadiation
An experimental arm using MRI imaging and excluding the transition zone from the target volume
brachytherapyRadiation
Standard ultrasound-guided brachytherapy with standard target volumes
brachytherapyRadiation
Standard ultrasound-guided brachytherapy with standard target volumes
| Study group | Role | What they receive |
|---|---|---|
| MRBT | MRI-assisted brachytherapy, the experimental arm Receives: Radiation: brachytherapy | |
| USBT1 | Standard ultrasound-guided brachytherapy performed by group 1 (control arm 1) Receives: Radiation: brachytherapy | |
| USBT2 | Standard ultrasound-guided brachytherapy performed by group 2 (control group 2) Receives: Radiation: brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess changes in generic and disease specific quality of life over time after treatment with brachytherapy for early prostate cancer
Measured: 10 years
Secondary outcomes (2)
To compare these outcomes after two alternative brachytherapy techniques, standard ultrasound guided brachytherapy and MRI guided prostate brachytherapy (MRIGPB)
Measured: 10 years
To identify factors associated with specific adverse outcomes.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startMar 2002
- Primary completionMar 2011 (estimated)
- Study completionMar 2011 (estimated)
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.
- More trials run by Massachusetts General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 414 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Metro West Medical Center, United States Department of Defense
- Investigators
- James Talcott, MD, SM, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681694
- Sponsor's protocol ID
- 01-264
- Status last verified
- Apr 2010
- First submitted
- 19 May 2008
- Last updated
- 28 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Outcomes of Alternative Brachytherapy Techniques for Early Prostate Cancer
- ClinicalTrials.gov ID
- NCT00681694
- Acronym / sponsor ID
- 01-264
- Conditions
- Prostate Cancer
- Keywords
- brachytherapy, radioactive seed implants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 414 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Metro West Medical Center, United States Department of Defense
- Study start
- Mar 2002
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 21 May 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 research study is to assess outcomes of treatment for early prostate cancer. Current treatments for early (non-metastatic) cancer may cause long-term impairments in the patients quality of life. In this study we will compare the outcomes of patients treated with two alternative brachytherapy (seed implants) techniques using a series of questionnaires.
Detailed description
Participants will be asked to complete a questionnaire about their health prior to treatment, at 1, 3 and 12 months after treatment and then once a year 4 more times.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MRBT | – | Radiation: brachytherapyMRI-assisted brachytherapy, the experimental arm |
| USBT1 | – | Radiation: brachytherapyStandard ultrasound-guided brachytherapy performed by group 1 (control arm 1) |
| USBT2 | – | Radiation: brachytherapyStandard ultrasound-guided brachytherapy performed by group 2 (control group 2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have indicated their intention to receive brachytherapy at one of the four accrual sites.
Key inclusion criteria (3 listed)
- Pathological diagnosis of an adenocarcinoma of the prostate
- 18 years of age or older
- Prior choice of either standard brachytherapy or MRIGPB as primary treatment
Key exclusion criteria (2 listed)
- Prior primary therapy (surgery or external beam radiation) for prostate cancer
- Current hormone ablation therapy
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 |
|---|---|---|
| brachytherapyAn experimental arm using MRI imaging and excluding the transition zone from the target volume | Radiation | MRBT |
| brachytherapyStandard ultrasound-guided brachytherapy with standard target volumes | Radiation | USBT1 |
| brachytherapyStandard ultrasound-guided brachytherapy with standard target volumes | Radiation | USBT2 |
Primary outcome
To assess changes in generic and disease specific quality of life over time after treatment with brachytherapy for early prostate cancer
Time frame: 10 years
2 secondary outcomes
To compare these outcomes after two alternative brachytherapy techniques, standard ultrasound guided brachytherapy and MRI guided prostate brachytherapy (MRIGPB)
Time frame: 10 years
To identify factors associated with specific adverse outcomes.
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2010.
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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.
Anita Rodrigues contact
James Talcott, MD, SM principal investigator
Massachusetts General Hospital
3 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 Massachusetts General Hospital at 3 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Talcott, MD, SM (617-724-5451, jtalcott@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess changes in generic and disease specific quality of life over time after treatment with brachytherapy for early prostate cancer (time frame: 10 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 28 Apr 2010.