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NCT02446444 · ClinicalTrials.gov registry record · Phase 3
Enzalutamide in Androgen Deprivation Therapy With Radiation Therapy for High Risk, Clinically Localised, Prostate Cancer
A Phase 3 study of Prostatic Neoplasms, sponsored by University of Sydney.
- Active
- Registry status
- Phase 3
- Development phase
- 802
- Enrollment target
- 20
- Study locations
NCT02446444: Active Phase 3 study of Prostatic Neoplasms, sponsored by University of Sydney.
NCT02446444 is a Phase 3 study of Prostatic Neoplasms that is active but no longer recruiting, run by University of Sydney. The registered enrollment target is 802 participants, above the 502-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (60% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02446444, a Phase 3 study of Prostatic Neoplasms, is active but no longer recruiting, sponsored by University of Sydney.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 802 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine the effectiveness of enzalutamide as part of adjuvant androgen deprivation therapy (ADT) with a luteinizing hormone releasing hormone analogue (LHRHA) in men having radiation therapy for localised prostate cancer at high risk of recurrence.
Primary Outcome
Metastasis free survival (MFS) is defined as the interval from the date of randomisation to the date of first evidence of metastasis or death from any cause, whichever occurs first, or the date of last known follow-up alive and without metastases. Evidence of metastasis includes findings on whole body bone scan (WBBS) or CT or MRI that are either characteristic of metastatic prostate cancer, and/or confirmed by other test results, e.g. cytology or histopathology, and lesion qualifies as new met
Conditions Studied
Interventions
- DRUG Enzalutamide
- DRUG Conventional NSAA
- DRUG LHRHA
- RADIATION External Beam Radiotherapy (78 Gy in 39 fractions or 46 Gy in 23 fractions plus brachytherapy boost)
Study Locations (20)
New South Wales
- Blacktown Hospital - Blacktown
- Campbelltown Hospital - Campbelltown
- Chris O'Brien Lifehouse - Camperdown
- Genesis Cancer Care Newcastle - Gateshead
- Gosford Hospital - Gosford
- St George Hospital - Kogarah
- Liverpool Hospital - Liverpool
- Orange Health Service - Orange
- Prince of Wales Hospital - Randwick
- Royal North Shore Hospital - St Leonards
- St Vincent's Hospital - Sydney
- Tamworth Rural Referral Hospital - Tamworth
- Sydney Adventist Hospital - Wahroonga
- Calvary Mater Newcastle - Waratah
- Westmead Hospital - Westmead
- Wollongong Hospital - Wollongong
Massachusetts
- Dana Farber Cancer Institute - Boston
- Beth Israel Deaconess Medical Center - Boston
Queensland
- Genesis Cancer Care Queensland - Wesley and Chermside - Auchenflower
- Townsville Hospital - Douglas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 802 participants |
| Start Date | 2014-03 |
| Est. Completion | 2026-03 |
| Phase | Phase 3 |
What the registry record for NCT02446444 still lists
NCT02446444 is an interventional study that assigns participants to a tested intervention. The registered 802 participants enrollment target is mid-sized for trials with a published cap, above the 502-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (60% higher).
The record links to 1 condition, with Prostatic Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which Enzalutamide is the first listed.
NCT02446444 names 20 study sites across 3 states, led by New South Wales, Massachusetts, Queensland.
Frequently Asked Questions
What is clinical trial NCT02446444 about?
NCT02446444 is a clinical study titled "Enzalutamide in Androgen Deprivation Therapy With Radiation Therapy for High Risk, Clinically Localised, Prostate Cancer". The purpose of this study is to determine the effectiveness of enzalutamide as part of adjuvant androgen deprivation therapy (ADT) with a luteinizing hormone releasing hormone analogue (LHRHA) in men having radiation therapy for localised prostate cancer at high risk of recurrence.
What is the current status of trial NCT02446444?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 802 participants. The study started on 2014-03. Estimated completion is 2026-03.
What conditions does trial NCT02446444 study?
This clinical trial studies the following conditions: Prostatic Neoplasms.
What interventions are being tested in trial NCT02446444?
The interventions under investigation include: Enzalutamide (DRUG), Conventional NSAA (DRUG), LHRHA (DRUG), External Beam Radiotherapy (78 Gy in 39 fractions or 46 Gy in 23 fractions plus brachytherapy boost) (RADIATION).
Who is sponsoring clinical trial NCT02446444?
This trial is sponsored by University of Sydney, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02446444 being conducted?
This trial has 20 study locations across Massachusetts, New South Wales, Queensland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostatic Neoplasms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02446444's enrollment target sits among peer trials
802 20th of 65 higher than 46 of 65 other Prostatic Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostatic Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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