Observation or Radical Treatment in Patients With Prostate Cancer

NCT00499174 | Terminated Results DMC

• 9 other identifiers: PR11U10CA077202CAN-NCIC-CTG-PR11CALGB-140602SWOG-PR11CDR0000557348RTOG-0873ECOG-JPR.11ICR-CTSU-ProSTART
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 13

Brief Summary

RATIONALE: Sometimes prostate tumours may not need treatment until they progress. In this case, observation may be sufficient. Radical treatments, such as radical prostatectomy or radiation therapy, may be effective in treating prostate cancer when it is first diagnosed. It is not yet known whether active surveillance is more effective than radical treatment as an initial intervention in favorable prognosis prostate cancer. PURPOSE: This randomized phase III trial is studying active surveillance to see how well it works compared with radical treatment as an initial intervention in patients with favorable prognosis prostate cancer.

Conditions

Prostate Cancer

Keywords

stage II prostate cancer; adenocarcinoma of the prostate

Outcome Measures

Primary Outcomes (1)

• Disease-specific Survival

  Time from the date of randomization to the date of death due to prostate cancer.

  5 years 6 months

Secondary Outcomes (1)

• Overall Survival

  5 years 6 months

Study Arms (2)

Active Surveillance

NO INTERVENTION

Active surveillance with radical intervention at the time one or more of the following occur: Biochemical progression; Grade progression; Clinical progression

Radical Intervention

ACTIVE COMPARATOR

Radical prostatectomy or radiotherapy based on patient and physician preference

Procedure: conventional surgery; Radiation: brachytherapy; Radiation: external beam radiation therapy; Procedure: Biopsies

Interventions

conventional surgery PROCEDURE

Radical prostatectomy

Radical Intervention

brachytherapy RADIATION

high dose rate temporary seed implant; permanent seed implant.

Radical Intervention

external beam radiation therapy RADIATION

3D conformal radiation therapy; intensity modulated radiation therapy.

Radical Intervention

Biopsies PROCEDURE

Periodic repeat biopsies

Radical Intervention

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Diagnosed within 6 months prior to randomization * Patient has been classified as favorable risk as defined by the following: * Clinical stage T1b, T1c, T2a, or T2b at the time of diagnosis * Clinical (diagnostic biopsy) Gleason score ≤ 6 * PSA ≤ 10.0 ng/mL * Physical examination, rectal examination, and transrectal ultrasound have been done within 6 months prior to randomization and radiographic studies, if indicated, are negative for metastasis * Patient is a suitable candidate for radical prostatectomy or radiotherapy PATIENT CHARACTERISTICS: * ECOG performance status 0, 1, or 2 * Patient has a minimum life expectancy of \> 10 years * In centers participating in the quality of life component of the study, the patient is able (i.e., sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French * No history of other malignancies, except adequately treated non-melanoma skin cancer, adequately treated superficial bladder cancer, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years from study randomization PRIOR CONCURRENT THERAPY: * No previous treatment for prostate cancer, including surgery (excluding biopsy and TURP), radiotherapy, or androgen deprivation therapy for greater than 3 months * No planned androgen therapy except in the context of radical therapy

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

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead
• National Cancer Institute (NCI): collaborator
• Cancer and Leukemia Group B: collaborator
• Eastern Cooperative Oncology Group: collaborator
• SWOG Cancer Research Network: collaborator
• Radiation Therapy Oncology Group: collaborator
• Institute of Cancer Research, United Kingdom: collaborator

Study Sites (13)

Clinical Research Unit at Vancouver Coastal

Vancouver, British Columbia, V5Z 1M9, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, AIB 3V6, Canada

Location

QEII Health Sciences Center

Halifax, Nova Scotia, B3H 1V7, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Ottawa Health Research Institute - General Division

Ottawa, Ontario, K1H 8L6, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

CHUM - Hopital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

McGill University - Dept. Oncology

Montreal, Quebec, H2W 1S6, Canada

Location

CHUQ-Pavillon Hotel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Related Publications (1)

• Fung-Kee-Fung SD, Porten SP, Meng MV, Kuettel M. The role of active surveillance in the management of prostate cancer. J Natl Compr Canc Netw. 2013 Feb 1;11(2):183-7. doi: 10.6004/jnccn.2013.0026.

  PMID: 23411385 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Brachytherapy; Biopsy

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; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Limitations and Caveats

Due to the early termination of the trial, the small number of patients and the shorter follow up, the reported information may not be reliable.

Results Point of Contact

• Title: Keyue Ding, Biostatistician
• Organization: Canadian Cancer Trials Group

kding@ctg.queensu.ca

613-533-6430

Study Officials

• Laurence H. Klotz, MD

  Toronto Sunnybrook Regional Cancer Centre

  STUDY CHAIR

• Adam S. Kibel, MD

  Washington University Siteman Cancer Center

  STUDY CHAIR

• Martin G. Sanda, MD

  Beth Israel Deaconess Medical Center

  STUDY CHAIR

• Ian M. Thompson, MD

  The University of Texas Health Science Center at San Antonio

  STUDY CHAIR

• Richard Choo, M.D

  Mayo Clinic

  STUDY CHAIR

• Chris Parker, M.D

  Royal Marsden Hospital, Sulton, UK

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 11, 2007
• Study Start: December 6, 2007
• Primary Completion: December 31, 2011
• Study Completion: January 10, 2013
• Last Updated: August 23, 2023
• Results First Posted: May 12, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (13)