Clinical Trials
Degarelix acetate has been evaluated across numerous clinical trials spanning Phase 1 to Phase 4 studies, including early phase 1 protocols. Clinical research primarily focuses on various stages and manifestations of prostate cancer, such as recurrent, stage IV, and oligometastatic prostatic adenocarcinoma, while additional investigations explore conditions including fertility, obesity, leukemia, multiple myeloma, myelodysplastic syndrome, and non-Hodgkin's lymphoma. These trials are backed by a diverse array of sponsors, including pharmaceutical companies such as Ferring Pharmaceuticals, cooperative clinical networks like the SWOG Cancer Research Network and Canadian Urology Research Consortium, and major academic medical centers including Johns Hopkins University and Memorial Sloan Kettering Cancer Center. Studies such as NCT00967018 and NCT00928434 represent key Phase 3 investigations, with recruitment statuses across the clinical portfolio encompassing completed, active, recruiting, and terminated protocols evaluating both short-term and long-term androgen deprivation outcomes.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04513717 | ACTIVE_NOT_RECRUITING | Prostate Adenocarcinoma; Stage III Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8 |
NRG Oncology |
2021-01-21 | PHASE3 |
| NCT04423211 | RECRUITING | Biochemically Recurrent Prostate Carcinoma; Metastatic Prostate Carcinoma; Prostate Adenocarcinoma; Stage IVB Prostate Cancer AJCC v8 |
ECOG-ACRIN Cancer Research Group |
2020-10-08 | PHASE3 |
| NCT06378866 | RECRUITING | Recurrent Castration-Sensitive Prostate Carcinoma; Recurrent Prostate Cancer; Castration-resistant Prostate Cancer; Biochemically Recurrent Prostate Carcinoma |
Mayo Clinic |
2024-06-03 | PHASE2 |
| NCT06397703 | RECRUITING | Prostate Cancer |
NYU Langone Health |
2024-04-16 | PHASE2 |
| NCT07455903 | RECRUITING | Prostate Cancer; Localized Prostate Carcinoma |
Baptist Health South Florida |
2026-07-29 | PHASE2 |
| NCT07335796 | RECRUITING | Prostate Cancer |
Memorial Sloan Kettering Cancer Center |
2026-01-09 | PHASE2 |
| NCT04176081 | NOT_YET_RECRUITING | Prostate Cancer |
University Health Network, Toronto |
2024-07-02 | PHASE2 |
| NCT06264882 | RECRUITING | Menopause; Estrogen Deficiency; Aging; Adiposity |
University of Colorado, Denver |
2024-06-01 | PHASE4 |
| NCT03678025 | RECRUITING | Castration Levels of Testosterone; Metastatic Prostatic Adenocarcinoma; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8 |
SWOG Cancer Research Network |
2018-09-24 | PHASE3 |
| NCT04734730 | RECRUITING | Castration-Sensitive Prostate Carcinoma; Metastatic Prostate Adenocarcinoma; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8 |
City of Hope Medical Center |
2021-05-04 | PHASE2 |
| NCT05501704 | RECRUITING | Male Breast Cancer; Hormone Receptor-positive Breast Cancer; Hormone Receptor Negative Breast Carcinoma |
Jose Pablo Leone |
2023-10-11 | PHASE2 |
| NCT04455750 | ACTIVE_NOT_RECRUITING | Castration-Resistant Prostate Carcinoma; Metastatic Prostate Adenocarcinoma; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8 |
Alliance for Clinical Trials in Oncology |
2021-10-14 | PHASE3 |
| NCT01786265 | ACTIVE_NOT_RECRUITING | Prostate Adenocarcinoma; Recurrent Prostate Carcinoma |
M.D. Anderson Cancer Center |
2013-02-05 | PHASE2 |
| NCT06218667 | WITHDRAWN | Prostate Cancer |
Memorial Sloan Kettering Cancer Center |
2024-01-11 | PHASE1; PHASE2 |
| NCT06066437 | RECRUITING | Prostate Cancer |
M.D. Anderson Cancer Center |
2024-03-29 | PHASE1; PHASE2 |
| NCT05873192 | RECRUITING | Prostate Cancer |
M.D. Anderson Cancer Center |
2025-06-03 | PHASE2 |
| NCT04989946 | ACTIVE_NOT_RECRUITING | Prostate Cancer |
University of Wisconsin, Madison |
2021-12-16 | PHASE1; PHASE2 |
| NCT01746849 | ACTIVE_NOT_RECRUITING | Leukemia; Multiple Myeloma; Myelodysplastic Syndrome; Non-Hodgkin's Lymphoma |
Memorial Sloan Kettering Cancer Center |
2012-12 | PHASE2 |
| NCT05050084 | ACTIVE_NOT_RECRUITING | Prostate Adenocarcinoma |
NRG Oncology |
2021-12-06 | PHASE3 |
| NCT03951831 | ACTIVE_NOT_RECRUITING | Prostate Cancer Metastatic |
Mark Stein |
2019-05-16 | PHASE2 |
| NCT04787744 | RECRUITING | Prostate Cancer; Oligometastasis; Oligorecurrence; Recurrent Prostate Cancer; Metastatic Prostate Cancer; De Novo Prostate Cancer |
VA Office of Research and Development |
2021-07-01 | PHASE2; PHASE3 |
| NCT02020070 | COMPLETED | Metastatic Castration Sensitive Prostate Cancer |
Memorial Sloan Kettering Cancer Center |
2013-12-18 | PHASE2 |
| NCT05917860 | ACTIVE_NOT_RECRUITING | Localized Prostate Carcinoma; Castration-Naive Prostate Cancer; Intermediate Risk Prostate Cancer; Prostate Cancer |
Turku University Hospital |
2023-07-18 | PHASE1 |
| NCT03070886 | COMPLETED | Stage I Prostate Adenocarcinoma AJCC v7; Stage II Prostate Adenocarcinoma AJCC v7; Stage III Prostate Adenocarcinoma AJCC v7 |
NRG Oncology |
2017-04-05 | PHASE2; PHASE3 |
| NCT03899077 | UNKNOWN | Cancer of Prostate |
Cancer Research Antwerp |
2019-04-05 | PHASE2 |
| NCT05617885 | COMPLETED | Metastatic Prostate Cancer; Non-metastatic Prostate Cancer; Prostate Cancer |
Praful Ravi, MB BCHir, MRCP |
2023-08-09 | PHASE1 |
| NCT05839119 | TERMINATED | Urothelial Carcinoma Bladder; Androgen Receptor Positive |
Brown University |
2023-10-02 | PHASE1 |
| NCT04301414 | COMPLETED | Prostate Cancer |
Columbia University |
2020-02-25 | EARLY_PHASE1 |
| NCT01542021 | COMPLETED | Prostate Cancer; Prostatic Adenocarcinoma |
Memorial Sloan Kettering Cancer Center |
2012-02-24 | |
| NCT01990196 | ACTIVE_NOT_RECRUITING | Prostate Cancer |
Jonsson Comprehensive Cancer Center |
2014-09-23 | PHASE2 |
| NCT03361735 | ACTIVE_NOT_RECRUITING | Prostate Adenocarcinoma |
City of Hope Medical Center |
2018-08-29 | PHASE2 |
| NCT05212857 | UNKNOWN | Prostate Cancer |
Fudan University |
2022-04 | PHASE2 |
| NCT03689699 | ACTIVE_NOT_RECRUITING | Prostate Cancer; Adenocarcinoma of the Prostate |
Mark Stein |
2018-10-11 | PHASE1; PHASE2 |
| NCT02799706 | ACTIVE_NOT_RECRUITING | Prostate Cancer |
European Organisation for Research and Treatment of Cancer - EORTC |
2017-09-25 | PHASE3 |
| NCT03056638 | TERMINATED | Prostate Cancer |
Memorial Sloan Kettering Cancer Center |
2017-03-28 | PHASE3 |
| NCT04182594 | UNKNOWN | Hormone Sensitive Prostate Cancer; Prostate Cancer; Cardiac Event |
Rabin Medical Center |
2020-01-17 | PHASE2 |
| NCT04248621 | UNKNOWN | Prostatic Neoplasms |
Wonju Severance Christian Hospital |
2020-01-23 | PHASE4 |
| NCT03947151 | COMPLETED | Invasive Ductal Breast Carcinoma |
Assistance Publique - Hôpitaux de Paris |
2019-11-28 | PHASE2 |
| NCT01994239 | ACTIVE_NOT_RECRUITING | Adenocarcinoma of Prostate |
UNICANCER |
2012-12 | PHASE2 |
| NCT02346253 | COMPLETED | Prostate Adenocarcinoma; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer |
Stanford University |
2015-01-13 | |
| NCT03358563 | COMPLETED | Prostate Cancer |
University of Wisconsin, Madison |
2018-01-17 | EARLY_PHASE1 |
| NCT03080116 | UNKNOWN | Prostate Cancer; Neoadjuvant Therapy; Androgen Antagonists; Prostatectomy |
Universitaire Ziekenhuizen KU Leuven |
2019-03-28 | PHASE2 |
| NCT02478775 | COMPLETED | Obesity; Fertility |
University of Colorado, Denver |
2015-07 | |
| NCT03240159 | UNKNOWN | Pregnancy, Ovarian |
Assisting Nature |
2017-02-15 | PHASE3 |
| NCT04397718 | COMPLETED | COVID-19 |
VA Office of Research and Development |
2020-07-06 | PHASE2 |
| NCT02663908 | TERMINATED | Prostate Cancer |
Ferring Pharmaceuticals |
2016-04-19 | PHASE3 |
| NCT03069937 | COMPLETED | Metastatic Prostatic Adenocarcinoma |
Medical University of South Carolina |
2017-03-01 | PHASE2 |
| NCT04585932 | WITHDRAWN | Biochemically Recurrent Prostate Carcinoma; Metastatic Prostate Carcinoma; Oligometastatic Prostate Carcinoma; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8 |
M.D. Anderson Cancer Center |
2020-11-24 | PHASE2 |
| NCT01751451 | COMPLETED | Prostate Cancer |
Memorial Sloan Kettering Cancer Center |
2012-12-18 | PHASE2 |
| NCT02726009 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2016-05 | PHASE4 |
| NCT04134130 | COMPLETED | Prostate Cancer Recurrent |
Lund University |
2019-09-16 | |
| NCT02324998 | COMPLETED | Prostate Cancer |
Cambridge University Hospitals NHS Foundation Trust |
2016-12 | PHASE1 |
| NCT02278185 | COMPLETED | Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer |
University of Colorado, Denver |
2015-11-11 | PHASE2 |
| NCT03202381 | UNKNOWN | Prostate Cancer |
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia |
2017-06-26 | PHASE4 |
| NCT02849990 | COMPLETED | Stage III Prostate Adenocarcinoma AJCC v7; Stage III Prostate Cancer AJCC v7; Stage IV Prostate Adenocarcinoma AJCC v7; Stage IV Prostate Cancer AJCC v7 |
University of Washington |
2017-03-09 | PHASE2 |
| NCT02475057 | COMPLETED | Prostatic Neoplasms; Cardiovascular Diseases |
Rabin Medical Center |
2015-08 | PHASE4 |
| NCT01512472 | TERMINATED | Prostate Cancer Recurrent |
Canadian Urology Research Consortium |
2012-01 | PHASE4 |
| NCT02489357 | COMPLETED | Stage IV Prostate Cancer |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2015-12-11 | |
| NCT02494713 | TERMINATED | Prostate Cancer |
The University of Texas Health Science Center, Houston |
2015-10 | PHASE2 |
| NCT02560051 | TERMINATED | Prostatic Neoplasms |
The University of Texas Health Science Center, Houston |
2015-11 | PHASE2 |
| NCT02005887 | COMPLETED | Breast Cancer Invasive Nos |
ETOP IBCSG Partners Foundation |
2014-02 | PHASE2 |
| NCT02015871 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2014-01 | PHASE3 |
| NCT01696877 | COMPLETED | Prostate Cancer Adenocarcinoma in Situ |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2013-01-18 | PHASE1; PHASE2 |
| NCT02526784 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2015-12 | PHASE3 |
| NCT01377389 | TERMINATED | Prostate Cancer |
M.D. Anderson Cancer Center |
2011-06-17 | PHASE2 |
| NCT01446991 | COMPLETED | Prostate Cancer |
British Columbia Cancer Agency |
2012-04 | PHASE2 |
| NCT02468284 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2015-07 | PHASE1 |
| NCT01862835 | COMPLETED | Normal Healthy Volunteers |
Mayo Clinic |
2013-05 | PHASE1 |
| NCT01731912 | COMPLETED | Prostate Adenocarcinoma; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer |
University of Washington |
2013-05 | |
| NCT01712763 | COMPLETED | Endometriosis |
Centre for Endocrinology and Reproductive Medicine, Italy |
2012-11 | PHASE3 |
| NCT02135445 | COMPLETED | Prostate Cancer |
Millennium Pharmaceuticals, Inc. |
2014-06 | PHASE2 |
| NCT01709942 | COMPLETED | PCOS; OHSS; INFERTILITY |
Centre for Endocrinology and Reproductive Medicine, Italy |
2012-11 | PHASE3 |
| NCT01852864 | UNKNOWN | Prostate Cancer |
University of Cambridge |
2011-07 | EARLY_PHASE1 |
| NCT01964170 | COMPLETED | Prostate Cancer |
Astellas Pharma Inc |
2013-08-13 | PHASE3 |
| NCT01744366 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2013-01 | PHASE3 |
| NCT02159690 | WITHDRAWN | Prostate Cancer; Localized Prostate Cancer |
Kenneth Pienta, MD |
2014-09 | PHASE2 |
| NCT01674270 | COMPLETED | Prostate Cancer |
University Health Network, Toronto |
2012-08 | PHASE2 |
| NCT01630967 | UNKNOWN | Prostate Neoplasm |
British Columbia Cancer Agency |
2012-08 | PHASE2 |
| NCT01491971 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2012-01 | PHASE2 |
| NCT01220869 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2010-12 | PHASE3 |
| NCT01344564 | COMPLETED | Prostate Cancer |
Urology of Virginia |
2011-04 | |
| NCT00928434 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2009-05 | PHASE3 |
| NCT00801242 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2008-12 | PHASE3 |
| NCT01261572 | COMPLETED | Prostatic Neoplasms |
Astellas Pharma Inc |
2010-10-12 | PHASE2 |
| NCT01215513 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2010-09 | PHASE3 |
| NCT00738673 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2008-07 | PHASE2 |
| NCT01242748 | TERMINATED | Prostate Cancer |
Ferring Pharmaceuticals |
2010-10 | PHASE3 |
| NCT00967018 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2009-08 | PHASE3 |
| NCT01071915 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2010-03 | PHASE3 |
| NCT01545882 | TERMINATED | Prostatic Neoplasms |
Ottawa Hospital Research Institute |
2011-05 | PHASE2 |
| NCT00451958 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2007-03 | PHASE3 |
| NCT00833248 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2009-04 | PHASE3 |
| NCT00884273 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2009-08 | PHASE3 |
| NCT00946920 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2009-06 | PHASE3 |
| NCT00947882 | COMPLETED | Lower Urinary Tract Symptoms (LUTS) |
Ferring Pharmaceuticals |
2009-08 | PHASE2 |
| NCT00831233 | TERMINATED | Prostate Cancer |
Ferring Pharmaceuticals |
2009-04 | PHASE3 |
| NCT00215683 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2005-02 | PHASE2; PHASE3 |
| NCT00268892 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2006-01 | PHASE2; PHASE3 |
| NCT00117286 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2005-03 | PHASE2; PHASE3 |
| NCT00527488 | COMPLETED | BPH |
Ferring Pharmaceuticals |
2007-10 | PHASE2 |
| NCT00468286 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2007-05 | PHASE2 |
| NCT00434122 | COMPLETED | Infertility, Female |
Ferring Pharmaceuticals |
2007-03 | PHASE2 |
| NCT00295750 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2006-02 | PHASE3 |
| NCT00116753 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2005-01 | PHASE2 |
| NCT00215657 | TERMINATED | Prostate Cancer |
Ferring Pharmaceuticals |
2003-03 | PHASE2 |
| NCT00245466 | TERMINATED | Prostate Cancer |
Ferring Pharmaceuticals |
2001-10 | PHASE2 |
| NCT00117312 | TERMINATED | Prostate Cancer |
Ferring Pharmaceuticals |
2002-10 | PHASE2 |
| NCT00116779 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2004-02 | PHASE2 |
| NCT00819156 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2004-02 | PHASE2 |
| NCT00818623 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2002-11 | PHASE2 |
| NCT00117949 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2002-04 | PHASE2 |
| NCT00819247 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2001-03 | PHASE2 |
| NCT00728533 | WITHDRAWN | Prostate Cancer |
Ferring Pharmaceuticals |
PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-08-17)
Check the
Degarelix acetate
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Compliance for Clinical Use
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
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Note: Technical data last updated: Sep 1, 2026.