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

Prostate Cancer Clinical Trial

— ELAAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00439751
• Other study ID #: OCOG-P1
• Status: Completed
• Phase: Phase 3
• First received: February 22, 2007
• Last updated: July 8, 2016
• Start date: April 2007
• Est. completion date: June 2016

Study information

• Verified date: June 2015
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	London Regional Cancer Program	London	Ontario
Canada	McGill Clinical Research Program	Montreal	Quebec
Canada	CHUM - Hôpital Notre-Dame	Montréal	Quebec
Canada	Ottawa Hospital Regional Cancer Centre	Ottawa	Ontario
Canada	CHUQ, L'Hotel-Dieu de Quebec	Quebec
Canada	Saskatoon Cancer Centre	Saskatoon	Saskatchewan
Canada	Odette Cancer Centre - Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	British Columbia Cancer Agency - Vancouver Centre	Vancouver	British Columbia
Canada	CancerCare Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)	AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to androgen independent disease (AID). AID is defined as the time from randomization to AID or last follow-up.		Every 6 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No