Immediate Versus Deferred Androgen Deprivation Therapy,Goserelin for Recurrent Prostate Cancer After Radical Radiotherapy

NCT00439751 | Completed Phase 3 DMC

• 1 other identifier: OCOG-P1
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 11

Brief Summary

This is a prospective, multicentre, open-labelled, randomized controlled trial comparing the efficacy of immediate versus deferred androgen deprivation therapy (ADT) using goserelin (Zoladex®) in men with recurrent prostate cancer after radical radiotherapy. 1100 patients will be accrued from participating Canadian Urological Oncology Group sites in an estimated time of 3 years. First analysis is planned for 7 years after study recruitment is completed.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Androgen Deprivation Therapy; Recurrence; Biochemical Failure; Goserelin

Outcome Measures

Primary Outcomes (1)

• Time to androgen independent disease (AID). AID is defined as the time from randomization to AID or last follow-up.

  Every 6 months

Secondary Outcomes (4)

• Time to complications of advanced malignancy (CAM) and number of CAMs experienced are secondary outcome measures.

  Every 6 months

• Quality of life

  Every 6 months

• Cause Specific Survival.

  Every 6 months

• Overall survival

  Every 6 months

Study Arms (2)

Immediate ADT

OTHER

Drug: Goserelin Acetate

Deferred ADT

OTHER

Drug: Goserelin Acetate

Interventions

Goserelin Acetate DRUG

Continuous goserelin, 12 week (10.8 mg) depot, will be used as ADT for both study arms. It is supplied as a sterile syringe for subcutaneous use.

Also known as: Zoladex®, Zoladex® LA

Deferred ADT; Immediate ADT

Eligibility Criteria

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

You may qualify if:

• Males over 18 years of age with histological confirmation of adenocarcinoma of the prostate.
• Biochemical progression after radical radiotherapy with a total prostate dose \> 52 Gy.
• In patients without previous radical prostatectomy, biochemical progression is defined as PSA in the range of nadir + 2 ng/mL (Phoenix definition) to ≤ 6 ng/mL (this PSA must be within 30 days of randomization).
• In patients with previous radical prostatectomy, biochemical progression is defined as a rising PSA (at least 2 values) in the range of 0.4 ng/mL to ≤ 3 ng/mL (most recent PSA must be within 30 days of randomization).

You may not qualify if:

• Patients who are within 4 years of their brachytherapy implantation date.
• Patients with medical conditions in which goserelin or bicalutamide is contraindicated in the opinion of the supervising oncologist or urologist.
• Patients with another active malignancy or malignancy treatment within 5 years (basal or squamous cell skin cancers are not excluded from this trial).
• Patients with geographic inaccessibility precluding them from necessary follow-up.
• Failure to provide written informed consent.

Sponsors & Collaborators

• Ontario Clinical Oncology Group (OCOG): lead
• AstraZeneca: collaborator

Study Sites (11)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

British Columbia Cancer Agency - Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 1C3, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, K1H 1C4, Canada

Location

Odette Cancer Centre - Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

CHUM - Hôpital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

McGill Clinical Research Program

Montreal, Quebec, H2W 1S5, Canada

Location

CHUQ, L'Hotel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Recurrence

Interventions

Goserelin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Andrew Loblaw, MD

  Odette Cancer Centre - Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2007
• First Posted: February 26, 2007
• Study Start: April 1, 2007
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: July 12, 2016

Record last verified: 2015-06

Locations

CA (11)