Implant Radiation Therapy or Surgery in Treating Patients With Prostate Cancer
NCT ID: NCT01098331
Last Updated: 2021-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
30 participants
INTERVENTIONAL
2008-06-01
2013-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm Rx1: Radical Prostatectomy
Arm Rx1: Radical Prostatectomy
Radical Prostatectomy
Arm Rx2: Brachytherapy
Arm Rx2: Brachytherapy
Brachytherapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Radical Prostatectomy
Brachytherapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
18 Years
120 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Southampton
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David Bottomley
Role: PRINCIPAL_INVESTIGATOR
Leeds Cancer Centre at St. James's University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ISRCTN88144169
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000668741
Identifier Type: -
Identifier Source: org_study_id