Clinical Trials

Multiple clinical trials across Phase I, Phase II, and Phase III evaluate nilutamide-containing therapeutic strategies, including androgen ablation and combination regimens, across localized, recurrent, oligometastatic, and metastatic prostatic adenocarcinoma. Sponsored primarily by major academic centers, cooperative networks, and federal research institutions, these studies range in recruitment status from completed and actively recruiting to terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
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
NCT01786265 ACTIVE_NOT_RECRUITING
Prostate Adenocarcinoma; Recurrent Prostate Carcinoma
M.D. Anderson Cancer Center
 2013-02-05 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
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
NCT00918385 TERMINATED
Prostate Cancer
Duke University
 2009-05 PHASE2
NCT00002633 COMPLETED
Prostate Cancer
NCIC Clinical Trials Group
 1995-02-08 PHASE3
NCT00003653 COMPLETED
Prostate Cancer
NCIC Clinical Trials Group
 1999-01-05 PHASE3
NCT00028769 COMPLETED
Prostate Cancer
SWOG Cancer Research Network
 2001-12 PHASE2
NCT00512668 TERMINATED
Adenocarcinoma of the Prostate; Recurrent Prostate Cancer
National Cancer Institute (NCI)
 2007-09 PHASE1
NCT00002855 COMPLETED
Prostate Cancer
M.D. Anderson Cancer Center
 1996-08 PHASE3
NCT00020254 COMPLETED
Prostate Cancer
National Cancer Institute (NCI)
 2000-06 PHASE2

(data from https://clinicaltrials.gov, updated on 2025-09-11)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nilutamide selectively binds to androgen receptors, competitively blocking endogenous dihydrotestosterone binding and preventing receptor translocation to the nucleus and androgen-responsive gene transcription. This inhibition of androgenic signaling pathways suppresses cell proliferation and promotes apoptosis in androgen-dependent prostatic epithelium, thereby inhibiting tumor growth in clinical contexts such as advanced and metastatic prostate cancer.

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.