Prostate CancerPhase 4NCT01379742
Comparison of Between ThinSeed™ and OncoSeed™ for Permanent Prostate Brachytherapy
A Phase 4 study testing RapidStrand seeds for use with 18g needle and ThinStrand in people with Prostate Cancer, run by Prostate Cancer Foundation of Chicago at 1 site in United States.
Trial summary
This study will investigate health related quality of life factors in patients undergoing low dose rate prostate brachytherapy. Patients will be randomized to Iodine-125 Thinstrand (for use with 20 g needles) or Rapidstrand (for use with standard 18 g needles). Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- RapidStrand seeds for use with 18g needle and ThinStrand
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Feb 2013
- Phase
- Phase 4
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate, clinical stage T1c - T2b, N0, M0
- Greater than or equal to 40 years of age
- Low and Low- Intermediate Risk prostate cancer
- Prostate volumes by TRUS ≤ 60 cc
- I-PSS score < 25 (alpha blockers allowed)
- Signed study-specific informed consent form prior to study entry
Who cannot join
- Lymph node involvement (N1)
- Evidence of distant metastases (M1)
- Radical surgery for carcinoma of the prostate
- Prior pelvic radiation
- Major medical or psychiatric illness, which in the investigator's opinion would prevent completion of treatment and would interfere with follow- up or ability to complete questionnaires
- Hip prosthesis
Show all 10Show fewer
- Inability or refusal to provide informed consent
- Evidence of Previous TURP
- Prior hormone therapy
- Prior TURP
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Chicago Prostate Center
Westmont, Illinois, 60559
Brian J Moran, MD, 630-654-2515, seeds@prostateimplant.com
Michelle H Braccioforte, MPH, 630-366-7860, mbraccioforte@prostateimplant.com
About this study
Official title: Comparison of Health Related Quality of Life and Other Clinical Parameters Between ThinSeed™ and OncoSeed™ for Permanent Low Dose Rate Implantation in Localized Prostate Cancer
This study will investigate health related quality of life factors in patients undergoing low dose rate prostate brachytherapy. Patients will be randomized to Iodine-125 Thinstrand (for use with 20 g needles) or Rapidstrand (for use with standard 18 g needles). Urinary, bowel, sexual function and bother will be measured by the EPIC questionnaire at various time intervals.
- Conditions
- Prostate Cancer
- Being tested
- RapidStrand seeds for use with 18g needle, ThinStrand
- Keywords
- prostate cancer, prostate brachytherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RapidStrand seeds for use with 18g needleDevice
Also called Both Rapidstrand and Thinstrand are manufactured by Oncura
Rapidstrand seeds are standard size and are used with 20 g needles
ThinStrandDevice
Also called Both ThinStrand and RapidStrand are manufactured by Oncura.
ThinStrand seeds are smaller in diameter and used with 20g needles
| Study group | Role | What they receive |
|---|---|---|
| Iodine-125 standard 18 g needle | Active comparator | Rapidstrand Receives: Device: RapidStrand seeds for use with 18g needle; Device: ThinStrand |
| 20 g needle | Active comparator | Thin Strand Receives: Device: RapidStrand seeds for use with 18g needle; Device: ThinStrand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life including urinary, bowel and sexual function as measured by the EPIC questionnaire
Randomized
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 posted23 Jun 2011 (estimated)
- Study startApr 2010
- Primary completionFeb 2013
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prostate Cancer Foundation of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian J Moran, MD, Principal investigator, Chicago Prostate Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379742
- Sponsor's protocol ID
- Thin-1
- Status last verified
- Feb 2013
- First submitted
- 20 Jun 2011
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Health Related Quality of Life and Other Clinical Parameters Between ThinSeed™ and OncoSeed™ for Permanent Low Dose Rate Implantation in Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT01379742
- Acronym / sponsor ID
- Thin-1
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, prostate brachytherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Prostate Cancer Foundation of ChicagoUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Feb 2013 (actual)
- First posted
- 23 Jun 2011 (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.
This study will investigate health related quality of life factors in patients undergoing low dose rate prostate brachytherapy. Patients will be randomized to Iodine-125 Thinstrand (for use with 20 g needles) or Rapidstrand (for use with standard 18 g needles). Urinary, bowel, sexual function and bother will be measured by the EPIC questionnaire at various time intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iodine-125 standard 18 g needle | Active comparator | Device: RapidStrand seeds for use with 18g needle, Device: ThinStrandRapidstrand |
| 20 g needle | Active comparator | Device: RapidStrand seeds for use with 18g needle, Device: ThinStrandThin Strand |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed adenocarcinoma of the prostate, clinical stage T1c - T2b, N0, M0
- Greater than or equal to 40 years of age
- Low and Low- Intermediate Risk prostate cancer
- Prostate volumes by TRUS ≤ 60 cc
- I-PSS score < 25 (alpha blockers allowed)
Key exclusion criteria (10 listed)
- Lymph node involvement (N1)
- Evidence of distant metastases (M1)
- Radical surgery for carcinoma of the prostate
- Prior pelvic radiation
- Major medical or psychiatric illness, which in the investigator's opinion would prevent completion of treatment and would interfere with follow- up or ability to complete questionnaires
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 |
|---|---|---|
| RapidStrand seeds for use with 18g needleAlso: Both Rapidstrand and Thinstrand are manufactured by OncuraRapidstrand seeds are standard size and are used with 20 g needles | Device | 20 g needle, Iodine-125 standard 18 g needle |
| ThinStrandAlso: Both ThinStrand and RapidStrand are manufactured by Oncura.ThinStrand seeds are smaller in diameter and used with 20g needles | Device | 20 g needle, Iodine-125 standard 18 g needle |
Primary outcome
Health related quality of life including urinary, bowel and sexual function as measured by the EPIC questionnaire
Time frame: 1 year
Randomized
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2013.
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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.
Brian J Moran, MD principal investigator
Chicago Prostate Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing RapidStrand seeds for use with 18g needle and ThinStrand in people with Prostate Cancer, run by Prostate Cancer Foundation of Chicago at 1 site 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 6 inclusion and 10 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 13 Feb 2013. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life including urinary, bowel and sexual function as measured by the EPIC questionnaire (time frame: 1 year). 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 13 Feb 2013.