A Phase 2 interventional study of Enzalutamide and Flutamide in Castration-resistant Prostate Cancer, sponsored by Taro Iguchi, MD, PHD. Completed at 1 site in Japan. Open to male participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-09-16.
Sponsored by Taro Iguchi, MD, PHD · 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 38th largest by enrollment, is one of 23 that started in 2014, is one of 65 in phase 2, and was the 47th registered.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 104 is above 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: 20 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:
Taro Iguchi, MD, PHD is the lead sponsor of 2 studies on the registry; none are open to participants now.
Taro Iguchi, MD, PHD has 2 studies filed under Prostatic Neoplasms — fewer than ten, so there is no comparison to draw.
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:
The objective of this study is to compare the efficacy and safety of enzalutamide or alternative AA therapy in CRPC participants who were previously treated with a combined androgen blockade therapy which included bicalutamide (Bic-CAB). Efficacy and safety of enzalutamide and alternative AA therapy will be evaluated, and effective therapy against CRPC after treatment with Bic-CAB will be investigated.
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
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.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
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.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Enzalutamide 160 mg administered orally once a day as four 40-mg soft capsules
Drug: Enzalutamide
Flutamide 125 mg administered orally three times a day as one tablet after meal
Drug: Flutamide
Percentage of participants whose prostate specific antigen (PSA) decreased 50 percent or more at month 3
Time frame: Month 3
Percentage of participants whose PSA decreased 50 percent or more at month 6
Time frame: Month 6
Percentage of participants who showed disease progression at month 3
Time frame: Month 3
Percentage of participants who showed disease progression at month 6
Time frame: Month 6
PSA progression-free survival (PFS)
Time frame: Up to 39 months
QOL measured by functional assessment of cancer therapy-prostate (FACT-P)
Time frame: Up to 39 months
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Enzalutamide
Taro Iguchi, MD, PHD