The primary objective of the trial is to assess if GnRH antagonists in combination with external beam radiation therapy improve progression free survival (progression that can be biological, clinical, or death) compared to GnRH agonists in combination with external beam radiation therapy.
Secondary objectives include:
Phase IIIb randomized stratified open-label comparative 2-arm superiority study with a pre-set non-inferiority boundary.
Registered GnRH antagonists, degarelix, will be given at the dose of 240 mg given as two subcutaneous injections of 120 mg at a concentration of 40 mg/mL on day 1, followed by 80 mg given as one subcutaneous injection at a concentration of 20 mg/mL every 28 days (2 days).
External beam radiotherapy (EBRT) to a total dose of 78-80 Gy, delivered as one daily fraction, five days a week, started between d1 and months 6 of the androgen deprivation therapy as per institution policy. The irradiation is the same as in the reference therapy arm.
The minimum duration of androgen deprivation with GnRH agonist or antagonist therapy is 18 months.
For each patient, the duration of therapy must be elected upfront by the treating physician among three possible options: 18, 24 or 36 months. The institution shall also declare upfront the duration of the neoadjuvant treatment they intend to deliver to each patient (between 0 and 6 months).
The primary endpoint is progression-free survival defined as the time in days from randomization to death, clinical or biochemical progression, whichever comes first.
Where
Secondary endpoints:
| Condition | prostate carcinoma, Prostate Cancer, Early, Recurrent, Malignant neoplasm of prostate, Prostate Disorders, prostate cancers, Prostatic disorder, Prostate Cancer |
|---|---|
| Treatment | Radiotherapy, Degarelix, approved GnRH agonist |
| Clinical Study Identifier | NCT02799706 |
| Sponsor | European Organisation for Research and Treatment of Cancer - EORTC |
| Last Modified on | 3 April 2023 |
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