Clinical trial · Interventional
Immediate Versus Deferred Androgen Deprivation Therapy,Goserelin for Recurrent Prostate Cancer After Radical Radiotherapy
A Randomized Comparison of Immediate Versus Deferred Androgen Deprivation Therapy Using Goserelin for Recurrent Prostate Cancer After Radical Radiotherapy.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Goserelin Acetate | Drug | Goserelin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Immediate ADT
- interventionNames
- Drug: Goserelin Acetate
- type
- OTHER
- label
- Deferred ADT
- interventionNames
- Drug: Goserelin Acetate
Primary outcomes (1)
- measure
- Time to androgen independent disease (AID). AID is defined as the time from randomization to AID or last follow-up.
- timeFrame
- Every 6 months
Secondary outcomes (4)
- measure
- Time to complications of advanced malignancy (CAM) and number of CAMs experienced are secondary outcome measures.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available