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

Sponsor

Ontario Clinical Oncology Group (OCOG) (Other)

Overall Status

Completed

CT.gov ID

NCT00439751

Collaborator

AstraZeneca (Industry)

Enrollment

Locations

Arms

110

Duration (Months)

7.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Goserelin Acetate	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

79 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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.

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Time to complications of advanced malignancy (CAM) and number of CAMs experienced are secondary outcome measures. [Every 6 months]
The time to CAM will be defined as the interval from randomization to the first CAM.
Quality of life [Every 6 months]
Measured at each 6 - month follow-up visit using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC).
Cause Specific Survival. [Every 6 months]
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.
Overall survival [Every 6 months]
Defined as the time from randomization to the time of death (from any cause) or to the last follow-up.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
2	British Columbia Cancer Agency - Vancouver Centre	Vancouver	British Columbia	Canada	V5Z 4E6
3	CancerCare Manitoba	Winnipeg	Manitoba	Canada	R3E 0V9
4	Juravinski Cancer Centre	Hamilton	Ontario	Canada	L8V 1C3
5	London Regional Cancer Program	London	Ontario	Canada	N6A 4L6
6	Ottawa Hospital Regional Cancer Centre	Ottawa	Ontario	Canada	K1H 1C4
7	Odette Cancer Centre - Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5
8	McGill Clinical Research Program	Montreal	Quebec	Canada	H2W 1S5
9	CHUM - Hôpital Notre-Dame	Montréal	Quebec	Canada	H2L 4M1
10	Saskatoon Cancer Centre	Saskatoon	Saskatchewan	Canada	S7N 4H4
11	CHUQ, L'Hotel-Dieu de Quebec	Quebec		Canada	G1R 2J6