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TerminatedNCT01098331Updated Dec 27, 2021

Implant Radiation Therapy or Surgery in Treating Patients With Prostate Cancer

An interventional study of Radical Prostatectomy and Brachytherapy in Prostate Cancer, sponsored by University of Southampton. Terminated at 1 site in United Kingdom. Open to male participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2021-12-27.

Sponsored by University of Southampton · Not applicable, Interventional, and Other

Why this study was terminated
Closed early due to poor recruitment

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Jun 2008, registered Apr 2010).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 120 Years
Sex
Male
01

Study 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.

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

02

Conditions studied

  • Prostate Cancer

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Keywords

  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
03

In context

Prostatic Neoplasms

6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.

This study's enrollment of 30 is below the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

University of Southampton is the lead sponsor of 121 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Other
    Arm Rx1: Radical Prostatectomy

    Arm Rx1: Radical Prostatectomy

    Procedure: Radical Prostatectomy

  • Other
    Arm Rx2: Brachytherapy

    Arm Rx2: Brachytherapy

    Procedure: Brachytherapy

Interventions

  • ProcedureRadical Prostatectomy
  • ProcedureBrachytherapy
06

What researchers measure

Primary outcomes

  1. Proportion of patients consenting to the treatment randomization

    Time frame: 6 months

  2. Feasibility of randomization in terms of average accrual rate per center during the last 6 months of recruitment

    Time frame: 6 months

Secondary outcomes

  1. Compliance with allocated treatment

    Time frame: 6 months

07

Study locations

1 site
  • Leeds Cancer Centre at St. James's University Hospital
    Leeds, England LS9 7TF, United Kingdom
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01098331
Lead sponsor
University of Southampton
Responsible party
Sponsor
First posted
Apr 2, 2010
Start date
Jun 1, 2008
Primary completion
Jun 1, 2013
Completion
Jun 1, 2013
Last update
Dec 27, 2021

Study contacts

David Bottomley
principal investigator · Leeds Cancer Centre at St. James's University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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