Prostate CancerPhase 2NCT01354951
Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy in Early Stage, Low Volume Prostate Cancer
A Phase 2 study testing Prostate Biopsy, Focal Brachytherapy , Assessment of QOL in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
Trial summary
The purpose of this study is to see what side effects a type of radiation treatment called focal brachytherapy has in treating early stage prostate cancer. The study is also looking at how useful focal brachytherapy will be in treating prostate cancer. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prostate Biopsy, Focal Brachytherapy , Assessment of QOL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2011to 6 Oct 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men ≥ 21 years of age with a life expectancy estimated to be > 10-years.
- Diagnosis of adenocarcinoma of the prostate confirmed by MSKCC or participating site pathology review.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Prostate cancer clinical stage T1c-T2a
- PSA < 10ng/mL (this will be the PSA level prompting the prostate biopsy)
- MRI evidence of one-sided disease performed within 3 months of registration
Show all 24Show fewer
- Prostate size <60 cc at time of treatment- if the prostate is larger, hormonal therapy is allowed to achieve the required size Screening biopsy parameters:
- Minimum of 10 biopsy cores
- Gleason grade 7 in two cores or less, with no primary Gleason grade 4 or 5 in any cores
- Unilateral cancer (only right-sided or left-sided, not bilateral)
- No more than 50 % cancer in any one biopsy core
- No more than 25 % of cores containing cancer
- Repeat transrectal or transperineal prostate biopsy that must meet the following parameters:
- Minimum of 12 biopsy cores
- Unilateral cancer (only right-sided or left-sided, not bilateral)
- Gleason grade 7 in two cores or less, with no primary Gleason grade 4 or 5 in any cores
- No more than 50 % cancer in any one biopsy core
- No more than 25 % of cores containing cancer
- Subject Exclusion Criteria:
- Medically unfit for anesthesia
- Evidence or suspicion of extracapsular extension on MRI
- IPSS score > 18
- Unable to receive MRI
- Prior radiotherapy for the current disease
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Md Anderson Cancer Center
Houston, Texas, 77030
North Shore LIJ
New Hyde Park, New York, 11040
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Phase II Study Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy Early Stage, Low Volume in Prostate Cancer
The purpose of this study is to see what side effects a type of radiation treatment called focal brachytherapy has in treating early stage prostate cancer. The study is also looking at how useful focal brachytherapy will be in treating prostate cancer. Additionally, the investigators would like to see how this type of treatment impacts quality of life.
- Conditions
- Prostate Cancer
- Being tested
- Prostate Biopsy, Focal Brachytherapy , Assessment of QOL
- Keywords
- Focal Brachytherapy, Endorectal coil MRI, Quality of Life, 11-056
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate Biopsy, Focal Brachytherapy , Assessment of QOLOther
A re-staging transrectal or transperineal ultrasound-guided prostate biopsy as currently performed at participating institutions. Focal brachytherapy will be performed at 8 weeks following the transrectal or transperineal biopsy or sooner if the patient has recovered from the repeat biopsy and the treating physician determines it is safe to proceed with treatment. The regions will be targeted with the prescription dose and receive 144 Gy of Iodine-125 (I-125). The quality-of-life assessment will focus on erectile function, urinary function, bowel function, and general health related quality of life. The patients will complete this assessment at baseline and then approximately 3 ± 1 months, 6 ± 1 months, 12 ± 2 months, 18 ± 2 months, and 24 ± 2 months after treatment.
| Study group | Role | What they receive |
|---|---|---|
| Prostate Biopsy, Focal Brachytherapy , Assessment of QOL | Experimental | This is a non-randomized, Phase II study examining the tolerance profile (primary endpoint) as well as the secondary endpoints of QOL changes, efficacy and the correlation of post-treatment MRI findings with post-treatment biopsy outcomes in men with early stage low volume prostate cancer treated with focal brachytherapy. Receives: Other: Prostate Biopsy, Focal Brachytherapy , Assessment of QOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Assess the Late Toxicity Outcomes
focal brachytherapy in patients with low risk prostate cancer This study will utilize the toxicity grading scale Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Measured: 6 months to 2 years
Secondary outcomes (3)
To Evaluate the Local Tumor Control After Focal Brachytherapy
as measured by the ability to obtain all negative biopsy cores 12 and 24 months after completion of therapy in the hemi-gland of where the focal therapy was administered. "All negative" means no prostate cancer;
Measured: 12 and 24 months
To Evaluate the Change From Baseline in QOL Indicators
Following focal brachytherapy in patients with early stage low volume localized prostate cancer. The scales to measure these domains were derived from the previously validated MSKCC Prostate-Health Related Quality of Life Questionnaire (PHRQOLQ
Measured: baseline and then approximately 3 ± 1 months, 6 ± 1 months, 12 ± 2 months, 18 ± 2 months, and 24 ± 2 months after treatment
To Correlate Post-treatment MRI Findings With Post-treatment Biopsy Outcomes
Post-treatment MRI outcome is defined as a 3-level categorical variable: positive, negative and undetermined. Post-treatment biopsy outcome is defined as a binary variable: positive and negative. We will examine the correlation between the 12-month MRI and 12-month biopsy, and between the 24-month MRI and 24-month biopsy. The correlation will be assessed by a Fisher exact test.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2011 (estimated)
- Study startMay 2011
- Primary completion6 Oct 2017
- Study completion6 Oct 2017
Why it stopped: Lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, M.D. Anderson Cancer Center, Northwell Health
- Responsible party
- Sponsor
- Investigators
- Michael Zelefsky, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354951
- Sponsor's protocol ID
- 11-056
- Status last verified
- Nov 2017
- First submitted
- 16 May 2011
- Last updated
- 19 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy Early Stage, Low Volume in Prostate Cancer
- ClinicalTrials.gov ID
- NCT01354951
- Acronym / sponsor ID
- 11-056
- Conditions
- Prostate Cancer
- Keywords
- Focal Brachytherapy, Endorectal coil MRI, Quality of Life, 11-056
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, M.D. Anderson Cancer Center, Northwell Health
- Study start
- May 2011
- Primary completion
- 6 Oct 2017 (actual)
- Study completion
- 6 Oct 2017 (actual)
- First posted
- 17 May 2011 (estimated)
- Results
- Posted 19 Oct 2018
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 see what side effects a type of radiation treatment called focal brachytherapy has in treating early stage prostate cancer. The study is also looking at how useful focal brachytherapy will be in treating prostate cancer. Additionally, the investigators would like to see how this type of treatment impacts quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate Biopsy, Focal Brachytherapy , Assessment of QOL | Experimental | Other: Prostate Biopsy, Focal Brachytherapy , Assessment of QOLThis is a non-randomized, Phase II study examining the tolerance profile (primary endpoint) as well as the secondary endpoints of QOL changes, efficacy and the correlation of post-treatment MRI findings with post-treatment biopsy outcomes in men with early stage low volume prostate cancer treated with focal brachytherapy. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Men ≥ 21 years of age with a life expectancy estimated to be > 10-years.
- Diagnosis of adenocarcinoma of the prostate confirmed by MSKCC or participating site pathology review.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Prostate cancer clinical stage T1c-T2a
- PSA < 10ng/mL (this will be the PSA level prompting the prostate biopsy)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Prostate Biopsy, Focal Brachytherapy , Assessment of QOLA re-staging transrectal or transperineal ultrasound-guided prostate biopsy as currently performed at participating institutions. Focal brachytherapy will be performed at 8 weeks following the transrectal or transperineal biopsy or sooner if the patient has recovered from the repeat biopsy and the treating physician determines it is safe to proceed with treatment. The regions will be targeted with the prescription dose and receive 144 Gy of Iodine-125 (I-125). The quality-of-life assessment will focus on erectile function, urinary function, bowel function, and general health related quality of life. The patients will complete this assessment at baseline and then approximately 3 ± 1 months, 6 ± 1 months, 12 ± 2 months, 18 ± 2 months, and 24 ± 2 months after treatment. | Other | Prostate Biopsy, Focal Brachytherapy , Assessment of QOL |
Primary outcome
To Assess the Late Toxicity Outcomes
Time frame: 6 months to 2 years
focal brachytherapy in patients with low risk prostate cancer This study will utilize the toxicity grading scale Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
3 secondary outcomes
To Evaluate the Local Tumor Control After Focal Brachytherapy
Time frame: 12 and 24 months
To Evaluate the Change From Baseline in QOL Indicators
Time frame: baseline and then approximately 3 ± 1 months, 6 ± 1 months, 12 ± 2 months, 18 ± 2 months, and 24 ± 2 months after treatment
To Correlate Post-treatment MRI Findings With Post-treatment Biopsy Outcomes
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Michael Zelefsky, MD principal investigator
Memorial Sloan Kettering Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prostate Biopsy, Focal Brachytherapy , Assessment of QOL in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center 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 24 inclusion and 0 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: stopped early, as of the sponsor's last update on 19 Oct 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Assess the Late Toxicity Outcomes (time frame: 6 months to 2 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 Oct 2018.