Study of Treatment Choice in Patients With Localized Prostate Cancer

NCT01177865 | Unknown

• 3 other identifiers: CDR0000682206UCL-COMPAREEU-21055
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Gathering information about patients with prostate cancer may help doctors learn more about how patients choose treatment options. PURPOSE: This study is looking at treatment choice in patients with localized prostate cancer.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer

Outcome Measures

Primary Outcomes (2)

• Preferences for, and trade-offs between, the attributes of pre-treatment evaluation with general anaesthetic biopsies and post-treatment frequency of biopsies

• Treatment choice in respect to risks to sexual function and urinary function, return to normal activities, aim to treat the whole gland or only cancer areas or important cancer areas, retreatment rate, and mortality rate

Secondary Outcomes (1)

• Correlation between attributes important to men and baseline demographics, functional status, and disease risk characteristics

Interventions

informational intervention OTHER

questionnaire administration OTHER

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histological diagnosis of adenocarcinoma of the prostate on transrectal or transperineal template prostate biopsies * Clinical stage ≤ T2c N0 M0 (radiological T3a allowed) * Local staging imaging as per guidelines to demonstrate localized disease (e.g., MRI, CT, and/or bone scan) * No metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging * No prior prostate surgery for cancer control (e.g., radical prostatectomy, high-intensity focused ultrasound ablation, cryosurgery, or photodynamic therapy) or other treatment for prostate cancer * Gleason grade ≤ 7 * Serum PSA ≤ 15 ng/mL PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior radiotherapy * No androgen suppression/hormone treatment within the previous 12 months for prostate cancer

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

Sponsors & Collaborators

• University College London Hospitals: lead

Study Sites (1)

University College of London Hospitals

London, England, WIT 3AA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Mark Emberton, MD, FRCS, MBBS

  University College London Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: HEALTH SERVICES RESEARCH
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 6, 2010
• First Posted: August 9, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2012
• Last Updated: August 26, 2013

Record last verified: 2010-11

Locations

GB (1)