A Phase 2 interventional study of Enzalutamide in Prostate Cancer, DNA and Androgen Receptor Abnormal, sponsored by The Netherlands Cancer Institute. Completed. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-29.
Sponsored by The Netherlands Cancer Institute · Phase 2, Interventional, and Treatment
Among 125 studies testing enzalutamide in Prostatic Neoplasms — 17 open to participants now, 38 under way, 9 of them phase 3. enzalutamide · Prostatic Neoplasms.
Among the 125 studies testing enzalutamide in Prostatic Neoplasms, this one is the 67th largest by enrollment, is one of 23 that started in 2014, is one of 65 in phase 2, and was the 74th registered.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →17 of the 125 studies testing enzalutamide in Prostatic Neoplasms are open now, in 12 countries. Each count lists the studies.
enzalutamide: first FDA approval 2012 (XTANDI), first EMA approval 2013. What it is approved for, and how studies give it, is on its page →
Of the 1,228 Prostatic Neoplasms studies recruiting now, 928 (76%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
The full table on the hub →125 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 23 started in 2014.
Median enrollment 52 across the 125 interventional studies. Of the 81 that completed or were terminated, 49 (60%) have results posted.
45 of 125 have an industry lead sponsor. The 10 most frequent:
The Netherlands Cancer Institute is the lead sponsor of 231 studies on the registry; 67 are open to participants now.
16 studies in Prostatic Neoplasms by The Netherlands Cancer Institute: 6 open now, 7 under way, none of them phase 3. Of 8 finished, 0 (0%) have results posted.
Among the 16 studies in Prostatic Neoplasms by The Netherlands Cancer Institute, this one is the 8th largest by enrollment of the 13 interventional ones, is the only one that started in 2014, is one of 2 in phase 2, and was the 4th registered.
The Netherlands Cancer Institute’s Prostatic Neoplasms studies by the year they started, since 1997.
13 of the studies testing enzalutamide in Prostatic Neoplasms that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03903835Phase 3Karolinska InstitutetProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer | 2026-12 |
| NCT02446405Phase 3University of SydneyEnzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer | 2026-12-31 |
| NCT05873192M.D. Anderson Cancer CenterPresurgical Phase II Study of Talazoparib in Combination With Enzalutamide in Prostate Cancer | 2026-12-31 |
| NCT03344211University of Southern CaliforniaEnzalutamide With or Without Radium Ra 223 Dichloride in Patients With Metastatic, Castration-Resistant Prostate Cancer | 2026-12-31 |
| NCT05406999The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolNeoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer | 2026-12-31 |
Among the 125 studies testing enzalutamide in Prostatic Neoplasms, from their registry updates:
Among The Netherlands Cancer Institute’s 16 in Prostatic Neoplasms:
Nothing recorded among them since 2026-09-25.
Rationale: Understanding the mechanisms of enzalutamide as an androgen receptor inhibitor in early prostate cancer could lead to improved patient selection for treatment.
Objective: To study the effects of enzalutamide on surgical margin status and AR / DNA interaction and gene expression.
Intervention : Men with localized prostate cancer will undergo an additional set of targeted tumor biopsies and will be subsequently treated with 3 months of enzalutamide. The prostatectomy specimen will be additionally sampled, ex vivo.
Rationale: Understanding the mechanisms of enzalutamide as an androgen receptor inhibitor in early prostate cancer could lead to improved patient selection for treatment.
Objective: To study the effects of enzalutamide on surgical margin status and AR / DNA interaction and gene expression.
Study design: A phase II prospective single-arm analysis. With a power of 80% to detect an expected reduction in positive surgical margin rate from 34% to 17% the investigators will have to included 55 men. For the AR/DNA interaction patients will serve as there own control since biopsies will be taken before and after enzalutamide treatment.
Study population: Patients over 18 years of age with localized prostate cancer that are planned for prostatectomy.
Intervention : Men with localized prostate cancer will undergo an additional set of targeted tumor biopsies and will be subsequently treated with 3 months of enzalutamide. The prostatectomy specimen will be additionally sampled, ex vivo.
Main study parameters/endpoints: 1. The effects of neoadjuvant androgen ablation on tumor downstaging. 2. The genetic and transcriptional changes caused by neoadjuvant androgen ablation by enzalutamide.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Burden and risks: Patients will be submitted to an additional set of 4 tumor targeted biopsies under local anesthesia and antibiotic prophylaxis. This comprises a 5 minute intervention with an elevated (2%) risk of postbiopsy urinary tract infection. Additionally oral enzalutamide treatment for a period of 3 months will result in temporary signs of androgen ablation such as: hot flushes (20%), headache (12%), diarrhea (1%), and seizures (0.9%). Benefits: neoadjuvant enzalutamide treatment has been shown to result in tumor and prostate downsizing. Earlier neoadjuvant androgen ablation studies with other agents have shown a reduced positive surgical margin rate and reduced intraoperative blood loss
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is a single-arm study. Patients will have biopsies, after which they will receive enzalutamide for 3 months. After 3 months they will have a prostatectomy.
Drug: Enzalutamide
Men with localized prostate cancer will undergo an additional set of targeted tumor biopsies and will be subsequently treated with 3 months of enzalutamide. The prostatectomy specimen will be additionally sampled, ex vivo.
Also known as: Xtandi
Effects of enzalutamide on tumor downstaging
To study the effects of enzalutamide on surgical margin status and AR / DNA interaction and gene expression.
Time frame: From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).
Genetic and transcriptional changes caused by enzalutamide
The genetic and transcriptional changes caused by neoadjuvant androgen ablation by enzalutamide.
Time frame: From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).
Clinical down-staging of enzalutamide pretreatment
To assess the effects of 3 months enzalutamide pretreatment on clinical down-staging
Time frame: From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).
AR-chromatin binding alterations and Ki-67 expression
Study the correlation between AR-chromatin binding alterations and Ki-67 expression.
Time frame: From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).
AR-dependant genes such as PSA, human kallikrein and PSMA
Compare the AR-chromatin binding with expression alterations of known AR-dependent genes such as PSA, human kallikrein and PSMA.
Time frame: From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).
Gleason grading
Compare AR-chromatin binding patterns with Gleason grading.
Time frame: From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).
Find associated genes in prostate tissue, using tissue microarray (TMA).
Find associated genes on TMA derived from prostatectomy specimens.
Time frame: From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).
No study locations are listed for this record.
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Enzalutamide
The Netherlands Cancer Institute →