Prostate CancerNCT01098331
Implant Radiation Therapy or Surgery in Treating Patients With Prostate Cancer
A study testing Radical Prostatectomy and Brachytherapy in people with Prostate Cancer, run by University of Southampton at 1 site in United Kingdom.
Trial summary
RATIONALE: Receiving standard information and watching a video or DVD at home that describes treatment options and treatment outcomes may help patients decide to receive treatment in a clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radical Prostatectomy and Brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2008to 1 Jun 2013
- Phase
- Interventional
- 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 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS
Meeting 1 of the following criteria:
- Prostate cancer or suspected prostate cancer confined to the prostate (Decision-Aid Randomization) Clinical stage T1/T2, Due for prostate biopsy or prostate biopsy performed in the last 6 weeks, PSA < 15 ng/mL
- Histologically confirmed prostate cancer (Treatment Randomization): Clinical stage T1/T2, Re-biopsy after a period of active surveillance is at the discretion of the treating investigator, Must meet 1 of the following risk criteria (PSA test < 3 months prior to treatment intervention), Low risk: Gleason score ≤ 6 (no tertiary grade 4 or 5) with a PSA of < 10 ng/mL, intermediate-risk: Gleason score 3 + 4 (no tertiary grade 5) with a PSA > 10 ng/mL but ≤ 15 ng/mL, Transrectal ultrasound prostate volume ≤ 50 cc
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Life expectancy > 10 years (Decision-Aid Randomization)
- Satisfactory results from biochemical and hematological profiles that, in the opinion of the investigator, does not preclude patient from the trial
- No unacceptable risk for radical prostatectomy or prostate brachytherapy
- INR < 1.5
- No severe lower urinary tract symptoms
- No significant obstructive urinary symptoms (i.e., peak urine flow rate < 10 mL per second, and/or post micturition bladder volume > 100 mL)
- No other clinical or medical condition that, in the opinion of the investigator, precludes patient from taking part in the trial
- No other active malignancy likely to interfere with subsequent protocol treatment and follow-up
PRIOR CONCURRENT THERAPY:
- No prior pelvic radiotherapy
- No prior abdominoperineal (AP) rectal excision
- No prior standard transurethral resection of prostate
- No prior or concurrent neoadjuvant or adjuvant hormonal treatment, (e.g., LHRH agonists, or anti-androgens or estrogens)
- At least 5 days since prior aspirin or clopidogrel
- No concurrent warfarin
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
About this study
Official title: Surgery and Brachytherapy: A Randomized Evaluation. Randomized Controlled Trial of Brachytherapy Versus Radical Prostatectomy in Good Risk Prostate Cancer: A Feasibility Study
RATIONALE: Receiving standard information and watching a video or DVD at home that describes treatment options and treatment outcomes may help patients decide to receive treatment in a clinical trial.
PURPOSE: This randomized clinical trial is studying implant radiation therapy to see how well it works compared with surgery in treating patients with prostate cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the proportion of patients consenting to the treatment randomization of brachytherapy vs radical prostatectomy in treating patients with good-risk prostate cancer.
- Determine the feasibility of randomization, in terms of average accrual rate per center, during the last 6 months of recruitment.
Secondary
- Determine the decisional quality post-treatment in these patients.
- Determine the compliance with allocated treatment in these patients.
- Determine the clinical failure in these patients.
- Determine the PSA relapse in these patients.
- Determine the patient-reported quality of life.
- Compare the toxicity of these regimens.
OUTLINE: This is a multicenter study.
- Part 1 (decision-aid randomization): Patients are stratified according to participating center. Patients are randomized to 1 of 2 Decision-Aid arms.
- Arm I (standard patient information): Patients receive standard patient information according to routine clinical practice and preferred materials of each center. This information typically includes booklets about prostate cancer and its treatment, contact details for sources of further information (e.g., prostate support groups, prostate charities, and web-based information), and access to a specialist nurse as required.
- Arm II (standard patient information + decision aid): In addition to standard information as described in Arm I, patients are given a 30-minute Decision-Aid video or DVD to take home. The Decision Aid describes the standard treatment options available to patients, provides detailed information about treatment outcomes in relation to individual patient characteristics, and seeks to help patients apply their own personal values to their treatment decision. Patients may watch the audio-visual aid as many times as they wish.
Patients who decide to choose a treatment are removed from study; patients who agree to undergo treatment randomization proceed to part 2 of the study.
- Part 2 (treatment randomization): Patients are stratified according to risk (low risk vs intermediate risk). Patients are randomized to 1 of 2 treatment arms.
- Arm I (radical prostatectomy): Patients undergo surgery within 60 days of randomization. The surgical technique for radical prostatectomy may be retropubic, transperineal, laparoscopic or robotic. Pelvic lymph node surgery is permitted at the discretion of the treating surgeon. Unilateral or bilateral nerve-sparing techniques may be used at the discretion of the treating surgeon.
- Arm II (brachytherapy): Patients undergo brachytherapy within 60 days of randomization. Brachytherapy seeds may be implanted using pre-loaded needles or a MICK® applicator of either iodine I 125 or palladium Pd 103.
Patient-reported quality-of-life data is collected to assess erectile function, urinary function, bowel function, and general quality of life at baseline and during follow up.
Patients are followed at 1 and 4 months, every 4 months for 2 years, every 6 months for 3 years, then annually for 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
- Conditions
- Prostate Cancer
- Being tested
- Radical Prostatectomy, Brachytherapy
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical ProstatectomyProcedure or surgery
BrachytherapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm Rx1: Radical Prostatectomy | Other | Arm Rx1: Radical Prostatectomy Receives: Procedure: Radical Prostatectomy |
| Arm Rx2: Brachytherapy | Other | Arm Rx2: Brachytherapy Receives: Procedure: Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients consenting to the treatment randomization
Measured: 6 months
Feasibility of randomization in terms of average accrual rate per center during the last 6 months of recruitment
Measured: 6 months
Secondary outcomes (1)
Compliance with allocated treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study start1 Jun 2008
- Primary completion1 Jun 2013
- Study completion1 Jun 2013
Why it stopped: Closed early due to poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Bottomley, Principal investigator, Leeds Cancer Centre at St. James's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098331
- Sponsor's protocol ID
- CDR0000668741
- Other IDs
- ISRCTN88144169
- Status last verified
- Dec 2021
- First submitted
- 1 Apr 2010
- Last updated
- 27 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eccles BK, Cross W, Rosario DJ, Doble A, Parker C, Logue J, Little L, Stanton L, Bottomley D. SABRE 1 (Surgery Against Brachytherapy - a Randomised Evaluation): feasibility randomised controlled trial (RCT) of brachytherapy vs radical prostatectomy in low-intermediate risk clinically localised prostate cancer. BJU Int. 2013 Aug;112(3):330-7. doi: 10.1111/bju.12127.
PubMed 23826842
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery and Brachytherapy: A Randomized Evaluation. Randomized Controlled Trial of Brachytherapy Versus Radical Prostatectomy in Good Risk Prostate Cancer: A Feasibility Study
- ClinicalTrials.gov ID
- NCT01098331
- Acronym / sponsor ID
- CDR0000668741
- Conditions
- Prostate Cancer
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed early due to poor recruitment
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- 1 Jun 2008 (actual)
- Primary completion
- 1 Jun 2013 (actual)
- Study completion
- 1 Jun 2013 (actual)
- First posted
- 2 Apr 2010 (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.
RATIONALE: Receiving standard information and watching a video or DVD at home that describes treatment options and treatment outcomes may help patients decide to receive treatment in a clinical trial.
PURPOSE: This randomized clinical trial is studying implant radiation therapy to see how well it works compared with surgery in treating patients with prostate cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the proportion of patients consenting to the treatment randomization of brachytherapy vs radical prostatectomy in treating patients with good-risk prostate cancer.
- Determine the feasibility of randomization, in terms of average accrual rate per center, during the last 6 months of recruitment.
Secondary
- Determine the decisional quality post-treatment in these patients.
- Determine the compliance with allocated treatment in these patients.
- Determine the clinical failure in these patients.
- Determine the PSA relapse in these patients.
- Determine the patient-reported quality of life.
- Compare the toxicity of these regimens.
OUTLINE: This is a multicenter study.
- Part 1 (decision-aid randomization): Patients are stratified according to participating center. Patients are randomized to 1 of 2 Decision-Aid arms.
- Arm I (standard patient information): Patients receive standard patient information according to routine clinical practice and preferred materials of each center. This information typically includes booklets about prostate cancer and its treatment, contact details for sources of further information (e.g., prostate support groups, prostate charities, and web-based information), and access to a specialist nurse as required.
- Arm II (standard patient information + decision aid): In addition to standard information as described in Arm I, patients are given a 30-minute Decision-Aid video or DVD to take home. The Decision Aid describes the standard treatment options available to patients, provides detailed information about treatment outcomes in relation to individual patient characteristics, and seeks to help patients apply their own personal values to their treatment decision. Patients may watch the audio-visual aid as many times as they wish.
Patients who decide to choose a treatment are removed from study; patients who agree to undergo treatment randomization proceed to part 2 of the study.
- Part 2 (treatment randomization): Patients are stratified according to risk (low risk vs intermediate risk). Patients are randomized to 1 of 2 treatment arms.
- Arm I (radical prostatectomy): Patients undergo surgery within 60 days of randomization. The surgical technique for radical prostatectomy may be retropubic, transperineal, laparoscopic or robotic. Pelvic lymph node surgery is permitted at the discretion of the treating surgeon. Unilateral or bilateral nerve-sparing techniques may be used at the discretion of the treating surgeon.
- Arm II (brachytherapy): Patients undergo brachytherapy within 60 days of randomization. Brachytherapy seeds may be implanted using pre-loaded needles or a MICK® applicator of either iodine I 125 or palladium Pd 103.
Patient-reported quality-of-life data is collected to assess erectile function, urinary function, bowel function, and general quality of life at baseline and during follow up.
Patients are followed at 1 and 4 months, every 4 months for 2 years, every 6 months for 3 years, then annually for 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm Rx1: Radical Prostatectomy | Other | Procedure: Radical ProstatectomyArm Rx1: Radical Prostatectomy |
| Arm Rx2: Brachytherapy | Other | Procedure: BrachytherapyArm Rx2: Brachytherapy |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Radical Prostatectomy | Procedure or surgery | Arm Rx1: Radical Prostatectomy |
| Brachytherapy | Procedure or surgery | Arm Rx2: Brachytherapy |
Primary outcome
Proportion of patients consenting to the treatment randomization
Time frame: 6 months
Feasibility of randomization in terms of average accrual rate per center during the last 6 months of recruitment
Time frame: 6 months
1 secondary outcome
Compliance with allocated treatment
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Closed early due to poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2021.
- Results publication: PubMed 23826842Eccles BK, Cross W, Rosario DJ, Doble A, Parker C, Logue J, Little L, Stanton L, Bottomley D. SABRE 1 (Surgery Against Brachytherapy - a Randomised Evaluation): feasibility randomised controlled trial (RCT) of brachytherapy vs radical prostatectomy in low-intermediate risk clinically localised prostate cancer. BJU Int. 2013 Aug;112(3):330-7. doi: 10.1111/bju.12127.
- Individual participant dataSharing planned: No
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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.
David Bottomley principal investigator
Leeds Cancer Centre at St. James's University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radical Prostatectomy and Brachytherapy in people with Prostate Cancer, run by University of Southampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 27 Dec 2021. 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 Kingdom. 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 stopped early (reason given: Closed early due to poor recruitment). Results are not available in the source record.
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?
Proportion of patients consenting to the treatment randomization (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01098331, which also lists 1 linked publication.
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 27 Dec 2021.