Clinical Trials

Multiple clinical trials spanning Early Phase 1 through Phase 4 evaluate flutamide across various endocrine and oncological conditions, primarily targeting metastatic prostatic adenocarcinoma, polycystic ovary syndrome, acne vulgaris, and metabolic syndrome. Supported by academic medical centers and major cooperative research networks—including the National Cancer Institute, SWOG, ECOG, EORTC, and M.D. Anderson Cancer Center—these studies reflect diverse recruitment statuses, including completed, recruiting, active, and terminated trials.

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
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
NCT06694350 NOT_YET_RECRUITING
Head and Neck Squamous Cell Carcinoma
Zhejiang Provincial People's Hospital
 2024-12 PHASE2
NCT01786265 ACTIVE_NOT_RECRUITING
Prostate Adenocarcinoma; Recurrent Prostate Carcinoma
M.D. Anderson Cancer Center
 2013-02-05 PHASE2
NCT05050084 ACTIVE_NOT_RECRUITING
Prostate Adenocarcinoma
NRG Oncology
 2021-12-06 PHASE3
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
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
NCT04597099 UNKNOWN
PCOS; Polycystic Ovary Syndrome
University of Virginia
 2022-10-26 EARLY_PHASE1
NCT03507608 COMPLETED
Prostate Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 2019-05-10 EARLY_PHASE1
NCT00930228 UNKNOWN
Polycystic Ovary Syndrome
University of Virginia
 2009-01 PHASE1
NCT00001521 COMPLETED
Congenital Adrenal Hyperplasia (CAH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 1995-06-08 PHASE3
NCT01889199 COMPLETED
Polycystic Ovary Syndrome (PCOS)
University of California, Los Angeles
 2013-04 PHASE2
NCT05478330 COMPLETED
Acne Vulgaris Superficial Mixed Comedonal and Inflammatory
Zagazig University
 2021-01-13
NCT04248621 UNKNOWN
Prostatic Neoplasms
Wonju Severance Christian Hospital
 2020-01-23 PHASE4
NCT02742675 UNKNOWN
Prostate Cancer
Fudan University
 2015-09 PHASE2
NCT00936390 COMPLETED
Prostate Cancer
Radiation Therapy Oncology Group
 2009-09 PHASE3
NCT02918968 COMPLETED
Prostate Cancer
Astellas Pharma Inc
 2016-11-02 PHASE4
NCT02346578 COMPLETED
Castration-resistant Prostate Cancer
Taro Iguchi, MD, PHD
 2014-12 PHASE2
NCT01428193 TERMINATED
Polycystic Ovary Syndrome; Hyperandrogenism
University of Virginia
 2006-09
NCT00450463 COMPLETED
Prostate Cancer
National Cancer Institute (NCI)
 2007-02-23 PHASE2
NCT00003645 TERMINATED
Prostate Cancer
M.D. Anderson Cancer Center
 1999-06-14 PHASE3
NCT00104741 COMPLETED
Prostate Cancer
UNICANCER
 2003-09-10 PHASE3
NCT02341404 COMPLETED
Prostate Cancer
Lidds AB
 2012-05 PHASE2
NCT00528866 COMPLETED
Prostate Cancer
Radiation Therapy Oncology Group
 2008-04 PHASE2
NCT01889199 Completed
Polycystic Ovary Syndrome (PCOS)
University of California Los Angeles|Oregon Health and Science University
 2013-04 Phase 2
NCT00699907 COMPLETED
Ovarian Cancer
University of Arizona
 2005-01 PHASE2
NCT00442689 COMPLETED
Polycystic Ovary Syndrome; Metabolic Syndrome
Northwestern University
 2006-07
NCT00223665 COMPLETED
Prostate Cancer
University of Washington
 1997-01-08 PHASE2
NCT02341404 Completed
Prostate Cancer
Lidds AB|Uppsala University
 2012-05 Phase 2
NCT00729560 TERMINATED
Polycystic Ovary Syndrome
Virginia Commonwealth University
 2008-07
NCT00002633 COMPLETED
Prostate Cancer
NCIC Clinical Trials Group
 1995-02-08 PHASE3
NCT00002597 COMPLETED
Prostate Cancer
Radiation Therapy Oncology Group
 1994-10 PHASE3
NCT00611923 COMPLETED
Premenstrual Syndrome
Weill Medical College of Cornell University
 2005-02 PHASE4
NCT00170157 COMPLETED
Prostate Adenocarcinoma; Prostate Carcinoma; Recurrent Prostate Carcinoma; Stage III Prostate Cancer; Stage IV Prostate Cancer
Mayo Clinic
 2004-06 PHASE2
NCT00388804 TERMINATED
Prostate Cancer
M.D. Anderson Cancer Center
 2005-02 PHASE3
NCT00003653 COMPLETED
Prostate Cancer
NCIC Clinical Trials Group
 1999-01-05 PHASE3
NCT00028769 COMPLETED
Prostate Cancer
SWOG Cancer Research Network
 2001-12 PHASE2
NCT00651326 TERMINATED
Prostate Cancer
NCIC Clinical Trials Group
 2008-06-02 PHASE3
NCT00004054 COMPLETED
Prostate Cancer
Radiation Therapy Oncology Group
 2000-01 PHASE3
NCT01122121 COMPLETED
Prostatic Neoplasms, Locally Advanced
Takeda
 2000-03 PHASE3
NCT06601205 COMPLETED
Prostate Cancer; Prostatic Intraepithelial Neoplasia
Ente Ospedaliero Ospedali Galliera
 2004-01-01 PHASE2; PHASE3
NCT00512668 TERMINATED
Adenocarcinoma of the Prostate; Recurrent Prostate Cancer
National Cancer Institute (NCI)
 2007-09 PHASE1
NCT01011751 COMPLETED
Adenocarcinoma, Prostate
Takeda
 2004-04 PHASE3
NCT00006214 COMPLETED
Prostate Cancer
Alliance for Clinical Trials in Oncology
 2000-08 PHASE2
NCT00817739 COMPLETED
Prostatic Neoplasms
Takeda
 1996-12 PHASE2
NCT00002855 COMPLETED
Prostate Cancer
M.D. Anderson Cancer Center
 1996-08 PHASE3
NCT00030654 COMPLETED
Prostate Cancer
Radiation Therapy Oncology Group
 2002-10 PHASE3
NCT00054106 COMPLETED
Prostate Cancer
NCIC Clinical Trials Group
 2002-12-10 PHASE1
NCT00023829 COMPLETED
Prostate Cancer
Radiation Therapy Oncology Group
 2001-08 PHASE3
NCT00002889 COMPLETED
Prostate Cancer
Alliance for Clinical Trials in Oncology
 1997-05 PHASE2
NCT00003323 COMPLETED
Prostate Cancer; Sexual Dysfunction and Infertility
Alliance for Clinical Trials in Oncology
 1998-05 PHASE2
NCT00026377 COMPLETED
Prostate Cancer
University of Chicago
 2001-11 PHASE1
NCT00003026 COMPLETED
Prostate Cancer
European Organisation for Research and Treatment of Cancer - EORTC
 1997-04 PHASE3
NCT00116220 COMPLETED
Prostate Cancer
Dana-Farber Cancer Institute
 1995-09 PHASE3
NCT00769548 COMPLETED
Prostate Cancer
Radiation Therapy Oncology Group
 1995-04 PHASE3
NCT00006214 Completed
Prostate Cancer
Alliance for Clinical Trials in Oncology|National Cancer Institute (NCI)
 2000-08 Phase 2
NCT00002881 COMPLETED
Prostate Cancer
Eastern Cooperative Oncology Group
 1996-10 PHASE3
NCT00003124 COMPLETED
Prostate Cancer
Herbert Irving Comprehensive Cancer Center
 1997-05 PHASE2
NCT00767286 COMPLETED
Prostate Cancer
Radiation Therapy Oncology Group
 PHASE3
NCT00003734 UNKNOWN
Prostate Cancer
St. Luke's Hospital, Ireland
 1998-12 PHASE3
NCT00001266 COMPLETED
Prostatic Neoplasm
National Cancer Institute (NCI)
 1990-10 PHASE2
NCT00003517 WITHDRAWN
Adenocarcinoma of the Prostate; Stage III Prostate Cancer; Stage IV Prostate Cancer; Recurrent Prostate Cancer
Burzynski Research Institute
 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-17)

Check the Flutamide product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Flutamide and its active metabolite competitively bind to the androgen receptor, preventing activation by endogenous testosterone and dihydrotestosterone. This inhibition blocks downstream receptor-mediated gene transcription and arrests androgen-dependent cellular proliferation, thereby suppressing tumor growth in prostate cancer and mitigating hyperandrogenic state in polycystic ovary syndrome.

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.