Clinical trial NCT03035032: A Study of ELIGARD® in Hormone-dependent Prostate Cancer Patients
Official title: A Phase IV Interventional Safety Study of ELIGARD® in Prostate Cancer Patients in Asia (ELIGANT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate Cancer
Keywords: Leuprolide acetate
Prostate cancer
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2017-01-27
Enrollment: 107
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study was to evaluate the safety profile of ELIGARD® in ethnic Asian prostate cancer patients.


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

Primary outcomes:
measure: Number of Participants With Eligard Related Adverse Events (AE)
timeFrame: From first dose of study drug up to 18 months
Secondary outcomes:
measure: Percentage of Participants With Testosterone Levels Less Than (<) 20, 20-50 and Greater Than (>) 50 Nanogram Per Deciliter (ng/dL) at Month 12
timeFrame: Month 12
measure: Percentage of Participants With Testosterone Levels < 20, 20-50 and > 50 ng/dL at Month 18
timeFrame: Month 18
measure: Time to PSA Progression
timeFrame: From first dose of study drug up to PSA progression (18 months)
measure: Percentage of Participants With Greater Than or Equal to (≥) 30% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18
timeFrame: Months 3, 6, 9, 12, 15 and 18
measure: Percentage of Participants With ≥50% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18
timeFrame: Months 3, 6, 9, 12, 15 and 18
measure: Percentage of Participants With ≥90% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18
timeFrame: Months 3, 6, 9, 12, 15 and 18
measure: Change From Baseline in EQ-5D-5L Health State Utility Index Score (Japan) at Months 6, 12 and 18
timeFrame: Baseline, months 6, 12 and 18
measure: Change From Baseline in EQ-5D-5L Health Status Utility Index Score (UK) at Months 6, 12 and 18
timeFrame: Baseline, months 6, 12 and 18
measure: Change From Baseline in EQ-5D-5L Health Status Utility Index Score (US) at Months 6, 12 and 18
timeFrame: Baseline, months 6, 12 and 18
measure: Change From Baseline in EQ-5D02-EQ-VAS Score at Months 6, 12 and 18
timeFrame: Baseline, months 6, 12 and 18
measure: Change From Baseline in EORTC QLQ-PR25 Score at Months 6, 12 and 18
timeFrame: Baseline, months 6, 12 and 18
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Site HK01001
city: Hong Kong
country: Hong Kong
facility: Site HK01002
city: Jakarta
country: Indonesia
facility: Site ID02001
state: DKI Jakarta
city: Batu Caves
country: Malaysia
facility: Site MY03002
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: Site MY03001
city: Makati City
country: Philippines
facility: Site PH04001
state: Metro Manila
city: Manila
country: Philippines
facility: Site PH04003
state: Metro Manila
city: San Juan
country: Philippines
facility: Site PH04002
state: Metro Manila
city: Singapore
country: Singapore
facility: Site SG05001
city: Singapore
country: Singapore
facility: Site SG05002
city: Singapore
country: Singapore
facility: Site SG05003
city: Taichung
country: Taiwan
facility: Site TW06001
city: Taichung
country: Taiwan
facility: Site TW06002
city: Taipei
country: Taiwan
facility: Site TW06003
city: Muang
country: Thailand
facility: Site TH07001
state: Chiang Mai
city: Hat Yai
country: Thailand
facility: Site TH07004
state: Songkhla
city: Bangkok
country: Thailand
facility: Site TH07003
city: Ho Chi Minh City
country: Vietnam
facility: Site VN08001
city: Ho Chi Minh City
country: Vietnam
facility: Site VN08002
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Malek R, Wu ST, Serrano D, Tho T, Umbas R, Teoh J, Lojanapiwat B, Ong TA, On WK, Thai SM, Kim J, Pophale R, Chiong E. ELIGANT: a Phase 4, interventional, safety study of leuprorelin acetate (ELIGARD(R)) in Asian men with prostate cancer. Transl Androl Urol. 2022 Feb;11(2):179-189. doi: 10.21037/tau-21-723.