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

A Randomized Comparison of Immediate Versus Deferred Androgen Deprivation Therapy Using Goserelin for Recurrent Prostate Cancer After Radical Radiotherapy.

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Goserelin Acetate

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.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1R 2J6
    • CHUQ, L'Hôtel-Dieu de Québec
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • British Columbia Cancer Agency - Vancouver Centre
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • CancerCare Manitoba
  • Ontario
    • Hamilton, Ontario, Canada, L8V 1C3
      • Juravinski Cancer Centre
    • London, Ontario, Canada, N6A 4L6
      • London Regional Cancer Program
    • Ottawa, Ontario, Canada, K1H 1C4
      • Ottawa Hospital Regional Cancer Centre
    • Toronto, Ontario, Canada, M4N 3M5
      • Odette Cancer Centre - Sunnybrook Health Sciences Centre
  • Quebec
    • Montreal, Quebec, Canada, H2W 1S5
      • McGill Clinical Research Program
    • Montréal, Quebec, Canada, H2L 4M1
      • CHUM - Hopital Notre-Dame
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Saskatoon Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to androgen independent disease (AID). AID is defined as the time from randomization to AID or last follow-up.	Every 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Every 6 months
Quality of life	Measured at each 6 - month follow-up visit using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC).	Every 6 months
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.	Every 6 months
Overall survival	Defined as the time from randomization to the time of death (from any cause) or to the last follow-up.	Every 6 months

Collaborators and Investigators

• Sponsor: Ontario Clinical Oncology Group (OCOG)
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Andrew Loblaw, MD, Odette Cancer Centre - Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: February 22, 2007
• First Submitted That Met QC Criteria: February 22, 2007
• First Posted (ESTIMATE): February 26, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): July 12, 2016
• Last Update Submitted That Met QC Criteria: July 8, 2016
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Prostate Cancer; Recurrence; Androgen Deprivation Therapy; Goserelin; Biochemical Failure
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Goserelin
• Other Study ID Numbers: OCOG-P1