Implant Radiation Therapy or Surgery in Treating Patients With Prostate Cancer

NCT01098331 | Terminated DMC

• 2 other identifiers: CDR0000668741ISRCTN88144169
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer

Outcome Measures

Primary Outcomes (2)

• Proportion of patients consenting to the treatment randomization

  6 months

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

  6 months

Secondary Outcomes (1)

• Compliance with allocated treatment

  6 months

Study Arms (2)

Arm Rx1: Radical Prostatectomy

OTHER

Arm Rx1: Radical Prostatectomy

Procedure: Radical Prostatectomy

Arm Rx2: Brachytherapy

OTHER

Arm Rx2: Brachytherapy

Procedure: Brachytherapy

Interventions

Radical Prostatectomy PROCEDURE

Arm Rx1: Radical Prostatectomy

Brachytherapy PROCEDURE

Arm Rx2: Brachytherapy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Gender Eligibility Details: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Southampton: lead

Study Sites (1)

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 23826842 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• David Bottomley

  Leeds Cancer Centre at St. James's University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 2, 2010
• Study Start: June 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 27, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)