Prostate CancerNCT00348465
Prostate Volume Changes Following Prostate Brachytherapy With Iodine-125 Seeds
An observational study of Prostate Cancer, run by New York Presbyterian Brooklyn Methodist Hospital.
Trial summary
The size of the prostate changes due to insertion of the radioactive seeds. We will measure the prostate size, before and after the procedure. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Brachytherapy with Iodine-125 seeds
- Type of treatment
- Surgery or procedure
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Mar 2008
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Prostate Cancer patients
Who may be able to join
- Pathologically confirmed diagnosis of prostate cancer
- T1-3 disease
- PSA <20 ng/ml
- Patient must sign a study-specific informed consent prior to enrollment.
Who cannot join
- Patients ineligible to brachytherapy
About this study
Official title: An Observational Study to Evaluate the Changes in Prostate Volume Over Time With The Use of Transrectal Ultrasound and Computed Tomography Following Permanent Prostate Brachytherapy With Iodine-125 Seeds.
The size of the prostate changes due to insertion of the radioactive seeds. We will measure the prostate size, before and after the procedure.
Read the detailed description
The prostate size will be measured using the TRUS and CT scan on days -1, 0, 1, 9, 30, and 60 days after the brachytherapy procedure.
- Conditions
- Prostate Cancer
- Being tested
- Brachytherapy with Iodine-125 seeds
- Keywords
- Brachytherapy, Prostate volume
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brachytherapy with Iodine-125 seedsProcedure or surgery
Also called Prostate Volume over time
Brachytherapy of the prostate, and measurements of the prostate volume using CT scan and TURS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startMay 2006
- Primary completionDec 2007
- Study completionMar 2008
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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Presbyterian Brooklyn Methodist Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hani Ashamalla, MD, New York Presbyterian Brooklyn Methodist Hospital
- Investigators
- Hani Ashamalla, MD, FCCP, Study chair, New York Presbyterian Brooklyn Methodist HospitalEwa Bieniek, MD, Principal investigator, NY Methodist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348465
- Sponsor's protocol ID
- NYM-353
- Status last verified
- Sep 2020
- First submitted
- 3 Jul 2006
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Evaluate the Changes in Prostate Volume Over Time With The Use of Transrectal Ultrasound and Computed Tomography Following Permanent Prostate Brachytherapy With Iodine-125 Seeds.
- ClinicalTrials.gov ID
- NCT00348465
- Acronym / sponsor ID
- NYM-353
- Conditions
- Prostate Cancer
- Keywords
- Brachytherapy, Prostate volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- New York Presbyterian Brooklyn Methodist HospitalUniversity, hospital or other
- Study start
- May 2006 (actual)
- Primary completion
- Dec 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 4 Jul 2006 (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 size of the prostate changes due to insertion of the radioactive seeds. We will measure the prostate size, before and after the procedure.
Detailed description
The prostate size will be measured using the TRUS and CT scan on days -1, 0, 1, 9, 30, and 60 days after the brachytherapy procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prostate Cancer patients
Key inclusion criteria (4 listed)
- Pathologically confirmed diagnosis of prostate cancer
- T1-3 disease
- PSA <20 ng/ml
- Patient must sign a study-specific informed consent prior to enrollment.
Key exclusion criteria (1 listed)
- Patients ineligible to 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 |
|---|---|---|
| Brachytherapy with Iodine-125 seedsAlso: Prostate Volume over timeBrachytherapy of the prostate, and measurements of the prostate volume using CT scan and TURS | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 18 Sep 2020.
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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.
Hani Ashamalla, MD, FCCP study chair
New York Presbyterian Brooklyn Methodist Hospital
Ewa Bieniek, MD principal investigator
NY Methodist Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by New York Presbyterian Brooklyn Methodist Hospital.
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 4 inclusion and 1 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 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
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 18 Sep 2020.