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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT00439751
First received: February 22, 2007
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Goserelin Acetate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Immediate Versus Deferred Androgen Deprivation Therapy Using Goserelin for Recurrent Prostate Cancer After Radical Radiotherapy.

Resource links provided by NLM:


Further study details as provided by Ontario Clinical Oncology Group (OCOG):

Primary Outcome Measures:
  • Time to androgen independent disease (AID). AID is defined as the time from randomization to AID or last follow-up. [ Time Frame: Indefinitely ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to complications of advanced malignancy (CAM) and number of CAMs experienced are secondary outcome measures. The time to CAM will be defined as the interval from randomization to the first CAM. [ Time Frame: Indefinitely ] [ Designated as safety issue: No ]
  • Quality of life will be measured at each 6 - month follow-up visit using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC), QLQ-C30 and QLQ-PR25. [ Time Frame: Indefinitely ] [ Designated as safety issue: No ]
  • Cause Specific Survival. The following will be considered as endpoints in assessing cause-specific survival: (1) Death adjudicated as due to prostate cancer (2) Death due to complications of ADT, irrespective of the status of malignancy. [ Time Frame: Indefinitely ] [ Designated as safety issue: No ]
  • Overall survival defined as the time from randomization to the time of death (from any cause) or to the last follow-up. [ Time Frame: Indefinitely ] [ Designated as safety issue: No ]

Estimated Enrollment: 1100
Study Start Date: April 2007
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Immediate ADT Drug: Goserelin Acetate
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.
Other Names:
  • Zoladex®
  • Zoladex® LA
Deferred ADT Drug: Goserelin Acetate
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.
Other Names:
  • Zoladex®
  • Zoladex® LA

Detailed Description:

Recurrent prostate cancer after radical radiation therapy is a common problem with often a long interval from biochemical failure to the time of symptomatic relapse. Androgen deprivation therapy (ADT) is the most commonly used intervention following radiation failure and currently is often started immediately after the recognition of biochemical failure in the absence of symptoms. ADT is associated with side effects that can impact on quality of life. It is unclear whether ADT reduces prostate-specific mortality. There is currently insufficient evidence on the timing of ADT with respect to prevention of prostate cancer death and quality of life and cost particularly for men with fast and slow prostate specific antigen (PSA) doubling times.

The general objective of the ELAAT trial is to determine the optimal timing of ADT in men with recurrent prostate cancer after radical radiotherapy.

Consenting patients who have undergone prior radical radiotherapy for prostate cancer and are now experiencing a recurrence will be screened for eligibility. If they are determined to be eligible, patients will be stratified according to PSA doubling time, pre-radiation Gleason Score, previous radical prostatectomy and clinical centre. After stratification, patients will be randomized to immediate versus deferred ADT based on the 1:1 ratio between the two arms.

Patients will be followed indefinitely and assessed formally at 6 month intervals after the date or randomization. Patients will be assessed for recurrent disease (biochemical failure), new primary cancer, complications of advanced malignancy, quality of life and overall survival.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males over 18 years of age with histological confirmation of adenocarcinoma of the prostate.
  2. 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).

Exclusion Criteria:

  1. Patients who are within 4 years of their brachytherapy implantation date.
  2. Patients with medical conditions in which goserelin or bicalutamide is contraindicated in the opinion of the supervising oncologist or urologist.
  3. Patients with another active malignancy or malignancy treatment within 5 years (basal or squamous cell skin cancers are not excluded from this trial).
  4. Patients with geographic inaccessibility precluding them from necessary follow-up.
  5. Failure to provide written informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439751

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 1C3
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Odette Cancer Centre - Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
McGill Clinical Research Program
Montreal, Quebec, Canada, H2W 1S5
CHUM - Hôpital Notre-Dame
Montréal, Quebec, Canada, H2L 4M1
Canada, Saskatchewan
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Canada
CHUQ, L'Hotel-Dieu de Quebec
Quebec, Canada, G1R 2J6
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
AstraZeneca
Investigators
Principal Investigator: Andrew Loblaw, MD Odette Cancer Centre - Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT00439751     History of Changes
Other Study ID Numbers: OCOG-P1
Study First Received: February 22, 2007
Last Updated: February 24, 2014
Health Authority: Canada: Health Canada

Keywords provided by Ontario Clinical Oncology Group (OCOG):
Prostate Cancer
Androgen Deprivation Therapy
Recurrence
Biochemical Failure
Goserelin

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Goserelin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014