Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT03035032
Eligibility Criteria:
Inclusion Criteria:
* A patient for whom the physician has decided to initiate treatment with a Luteinizing Hormone Releasing Hormone (LHRH) agonist in standard clinical practice
* Biopsy-proven prostate adenocarcinoma
* Locally advanced prostate cancer with biochemical relapse radical prostatectomy and/or radiotherapy, OR hormonal treatment-naive advanced or metastatic prostate cancer patient who has not received chemotherapy and has no plans to undergo treatment with chemotherapy at study entry.
* Patient who indicates that once the study is completed, he expects having access to androgen deprivation therapy (ADT), either medical or surgical, within the local healthcare system (either through public/ private health insurance or out of pocket payment).
Exclusion Criteria:
* Patient with castrate resistant prostate cancer
* Patient who previously underwent bilateral orchiectomy
* Patient who has received prior treatment with LHRH analogues
* Prior or concomitant treatment with systemic chemotherapy. A patient where there is a likelihood to receive systemic chemotherapy should not be enrolled
* Life expectancy of \< 1 year due to comorbidities
* Participation in another interventional clinical trial within one month prior to study entry or during the duration of the study
* Patient who plans to receive intermittent ADT at the time of study entry
* Patient receiving non-palliative radiotherapy within 3 months prior to study entry
* Patient receiving adjuvant ADT in combination with definitive radiotherapy
* Patient with metastatic hormonal treatment-naive prostate cancer, for whom chemo-hormonal treatment (combination of Docetaxel and ADT) is indicated.
* Patient with hypersensitivity to gonadotropin releasing hormone (GnRH), GnRH agonist analogs or any of the components of ELIGARD®
* Patient with any contraindication for ELIGARD® use based on local prescribing information
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03035032
Study Brief:
Protocol Section:
NCT03035032