Observation or Radical Treatment in Patients With Prostate Cancer

• ClinicalTrials.gov Identifier: NCT00499174
• Recruitment Status: Terminated
• First Posted: July 11, 2007
• Results First Posted: May 12, 2021
• Last Update Posted: May 12, 2021
• Sponsor: NCIC Clinical Trials Group
• Collaborators: National Cancer Institute (NCI); Cancer and Leukemia Group B; Eastern Cooperative Oncology Group; Southwest Oncology Group; Radiation Therapy Oncology Group; Institute of Cancer Research, United Kingdom
• Information provided by (Responsible Party): Canadian Cancer Trials Group ( NCIC Clinical Trials Group )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Procedure: conventional surgery; Radiation: brachytherapy; Radiation: external beam radiation therapy; Procedure: Biopsies	Not Applicable

Detailed Description:

OBJECTIVES:

Primary

• To compare disease-specific survival of patients with favorable risk prostate cancer treated with radical prostatectomy or radical radiotherapy at the time of initial diagnosis vs active surveillance and selective intervention based on pre-specified biochemical, histological, or clinical progression criteria.

Secondary

• To compare overall survival, quality of life using the EPIC-26, RAND SF-12, and State-Trait Anxiety Inventory, distant disease-free survival, PSA relapse/progression after radical intervention, and initiation of androgen deprivation therapy between the two treatment arms.
• To determine the proportion of patients on the active surveillance arm who receive radical intervention for prostate cancer.
• To determine if PSA doubling-time prior to diagnosis predicts eventual outcome.
• To determine if molecular biomarkers predict outcome.

OUTLINE: This is a prospective, randomized, multicenter study. Patients are stratified by treatment center, ECOG performance status (0 vs 1 or 2), disease stage (T1 vs T2), baseline PSA value (ng/mL or μg/L) (< 5.0 vs ≥ 5.0 and ≤ 10.0), and age (< 65 years vs ≥ 65 years). Patients are randomized to 1 of 2 arms.

• Arm I: Patients undergo radical intervention (radical prostatectomy or radiotherapy [external-beam radiotherapy 5 days a week for 4-8 weeks; permanent prostate brachytherapy; or high-dose rate temporary brachytherapy], based on patient and physician preference).
• Arm II: Patients undergo active surveillance with radical intervention at the time one or more pre-specified criteria (biochemical progression, histologic/grade progression, and/or clinical progression) are met.

Quality of life is assessed by the EPIC-26, RAND SF-12, and State Anxiety Inventory at baseline, periodically during study treatment, and after completion of radical treatment.

After completion of radical treatment, patients are followed every 6 months.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed With Favourable Risk Prostate Cancer [START]
• Actual Study Start Date: June 15, 2007
• Actual Primary Completion Date: December 31, 2011
• Actual Study Completion Date: January 10, 2013

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Active Surveillance; Active surveillance with radical intervention at the time one or more of the following occur: Biochemical progression; Grade progression; Clinical progression
Active Comparator: Radical Intervention; Radical prostatectomy or radiotherapy based on patient and physician preference	Procedure: conventional surgery; Radical prostatectomy; Radiation: brachytherapy; high dose rate temporary seed implant; permanent seed implant.; Radiation: external beam radiation therapy; 3D conformal radiation therapy; intensity modulated radiation therapy.; Procedure: Biopsies; Periodic repeat biopsies

Outcome Measures

Primary Outcome Measures :

1. Disease-specific Survival [ Time Frame: 5 years 6 months ]
   Time from the date of randomization to the date of death due to prostate cancer.

Secondary Outcome Measures :

1. Overall Survival [ Time Frame: 5 years 6 months ]
   Time from randomization to the date of death due to any causes.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Canada, British Columbia

Clinical Research Unit at Vancouver Coastal

Vancouver, British Columbia, Canada, V5Z 1M9

Canada, Manitoba

CancerCare Manitoba

Winnipeg, Manitoba, Canada, R3E 0V9

Canada, Newfoundland and Labrador

Dr. H. Bliss Murphy Cancer Centre

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

Canada, Nova Scotia

QEII Health Sciences Center

Halifax, Nova Scotia, Canada, B3H 1V7

Canada, Ontario

London Regional Cancer Program

London, Ontario, Canada, N6A 4L6

Ottawa Health Research Institute - General Division

Ottawa, Ontario, Canada, K1H 8L6

Odette Cancer Centre

Toronto, Ontario, Canada, M4N 3M5

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada, M5G 2M9

Canada, Quebec

CHUM - Hopital Notre-Dame

Montreal, Quebec, Canada, H2L 4M1

McGill University - Dept. Oncology

Montreal, Quebec, Canada, H2W 1S6

CHUQ-Pavillon Hotel-Dieu de Quebec

Quebec City, Quebec, Canada, G1R 2J6

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada, J1H 5N4

Canada, Saskatchewan

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada, S4T 7T1

Sponsors and Collaborators

NCIC Clinical Trials Group

National Cancer Institute (NCI)

Cancer and Leukemia Group B

Eastern Cooperative Oncology Group

Southwest Oncology Group

Radiation Therapy Oncology Group

Institute of Cancer Research, United Kingdom

Investigators

• Study Chair: 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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: NCIC Clinical Trials Group
• ClinicalTrials.gov Identifier: NCT00499174
• Other Study ID Numbers: PR11; U10CA077202 ( U.S. NIH Grant/Contract ); CAN-NCIC-CTG-PR11 ( Registry Identifier: PDQ ); CALGB-140602 ( Other Identifier: CALGB Assigned Trial Code ); SWOG-PR11 ( Other Identifier: SWOG Assigned Trial Code ); CDR0000557348 ( Other Identifier: PDQ ); RTOG-0873 ( Other Identifier: RTOG ); ECOG-JPR.11 ( Other Identifier: ECOG Assigned Trial Code ); ICR-CTSU-ProSTART ( Other Identifier: CTSU )
• First Posted: July 11, 2007
• Results First Posted: May 12, 2021
• Last Update Posted: May 12, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Canadian Cancer Trials Group ( NCIC Clinical Trials Group ):

stage II prostate cancer; adenocarcinoma of the prostate

Additional relevant MeSH terms:

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