Last reviewed · How we verify
Enzalutamide in Patients With High-risk Prostate Cancer
Phase 2 trial testing enzalutamide in Adenocarcinoma of the Prostate in 42 participants. Completed in 26 April 2017.
| Lead sponsor | Case Comprehensive Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 11 November 2013 |
| Primary completion | 29 March 2017 |
| Estimated completion | 26 April 2017 |
| Sites | 1 location across United States |
Case Comprehensive Cancer Center — full company profile →
18 and older, male only, with Adenocarcinoma of the Prostate. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Clinical efficacy is measured as time to disease progression defined by biochemical recurrence (BCR). BCR was defined as PSA ≥0.2ng/mL on 2 consecutive lab results or any PSA rise that resulted in subsequent therapy.
| Group | Value | 95% CI |
|---|---|---|
| Enzalutamide | 31 | 13 – 40 |
The number of patients that experience adverse events related to the study drug. NCI Cancer Clinical Trials Common Toxicity Criteria (version 4.0) will be utilized.
| Group | Value | 95% CI |
|---|---|---|
| Enzalutamide | 41 |
Time frame: Adverse events were collected while participants were on treatment up to 2 years (24 cycles).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Enzalutamide |
|---|---|---|
| Abducens nerve disorder | Nervous system disorders | — |
| Bone infection | Infections and infestations | — |
| Thromboembolic event | Vascular disorders | — |
| Reaction | System | Enzalutamide |
|---|---|---|
| Fatigue | General disorders | — |
| Gynecomastia | Reproductive system and breast disorders | — |
| Pain | General disorders | — |
| Weight gain | Investigations | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Breast pain | Reproductive system and breast disorders | — |
| Alopecia | Skin and subcutaneous tissue disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Weight loss | Investigations | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Hot flashes | Vascular disorders | — |
| Hyperkalemia | Metabolism and nutrition disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Lymphocyte count decreased | Investigations | — |
| Nausea | Gastrointestinal disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Headache | Nervous system disorders | — |
| Insomnia | Psychiatric disorders | — |
| Nervous system disorders - Other, specify | Nervous system disorders | — |
| Dizziness | Nervous system disorders | — |
| Dry skin | Skin and subcutaneous tissue disorders | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| White blood cell decreased | Investigations | — |
| Aspartate aminotransferase increased | Investigations | — |
| Cognitive disturbance | Nervous system disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Hypertension | Vascular disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Memory impairment | Nervous system disorders | — |
| Paresthesia | Nervous system disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Dry mouth | Gastrointestinal disorders | — |
| Dysgeusia | Nervous system disorders | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Skin infection | Infections and infestations | — |
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | — |
Most-reported serious reactions: Abducens nerve disorder, Bone infection, Thromboembolic event.
Data from ClinicalTrials.gov NCT01927627 adverse events section.
The purpose of this study is to see how long it takes for prostate cancer to come back in patients who have had surgery to remove their prostate gland (radical prostatectomy), while being treated with enzalutamide (formerly known as MDV3100). Enzalutamide is known as an androgen-receptor signaling inhibitor, which means that it blocks activity of the male hormone, testosterone. Most prostate cancers are dependent on testosterone for growth. In this study, patients will take enzalutamide after surgery to see if it keeps their cancer from coming back.
3 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01927627.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing