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Ketoconazole and Dexamethasone in Prostate Cancer
Phase 2 trial testing Ketoconazole in Prostate Cancer in 32 participants. Completed in 9 October 2014.
| Lead sponsor | University of California, San Francisco |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 11 December 2009 |
| Primary completion | 11 December 2012 |
| Estimated completion | 9 October 2014 |
| Sites | 1 location across United States |
University of California, San Francisco
18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The number of participants who experience a ≥30% decline in PSA between the time of first progression on ketoconazole and hydrocortisone and eight weeks after dexamethasone therapy was initiated.
| Group | Value | 95% CI |
|---|---|---|
| Ketoconazole + Dexamethasone | 0 |
Time frame: Up to 5 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Ketoconazole + Hydrocortis… | Ketoconazole + Dexamethasone |
|---|---|---|---|
| Dehydration | Gastrointestinal disorders | — | — |
| Peripheral arterial ischemia | Vascular disorders | — | — |
| Renal failure | Renal and urinary disorders | — | — |
| Obstruction, GU - Ureter | Renal and urinary disorders | — | — |
| Fracture | Musculoskeletal and connective tissue disorders | — | — |
| Infection with unknown ANC - Bladder (urinary) | Infections and infestations | — | — |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS | Infections and infestations | — | — |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary) | Infections and infestations | — | — |
| Infection - Other | Infections and infestations | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | Ketoconazole + Hydrocortis… | Ketoconazole + Dexamethasone |
|---|---|---|---|
| Fatigue (asthenia, lethargy, malaise) | General disorders | — | — |
| Dermatology - Other | Skin and subcutaneous tissue disorders | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — |
| Edema: limb | General disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| AST, SGOT(serum glutamic oxaloacetic transaminase) increased | Investigations | — | — |
| ALT, SGPT (serum glutamic pyruvic transaminase) increased | Investigations | — | — |
| Urinary frequency/urgency | Renal and urinary disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Abdomen Pain, NOS | Gastrointestinal disorders | — | — |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | — | — |
| Rash/desquamation | Skin and subcutaneous tissue disorders | — | — |
| Rash: hand-foot skin reaction | Skin and subcutaneous tissue disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Pain - Back | Musculoskeletal and connective tissue disorders | — | — |
| Pain - Extremity-limb | Musculoskeletal and connective tissue disorders | — | — |
| Pain - Other | General disorders | — | — |
| Anorexia | Gastrointestinal disorders | — | — |
| Insomnia | General disorders | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Creatinine increased | Investigations | — | — |
| Pain - Joint | Musculoskeletal and connective tissue disorders | — | — |
| Pain - Chest/thorax NOS | General disorders | — | — |
| Renal/Genitourinary | Renal and urinary disorders | — | — |
| Mood alteration - Depression | Psychiatric disorders | — | — |
| Cognitive disturbance | Nervous system disorders | — | — |
| Syncope (fainting) | Nervous system disorders | — | — |
| Fracture | Musculoskeletal and connective tissue disorders | — | — |
| Cardiac Arrhythmia - Other | Cardiac disorders | — | — |
| Supraventricular and nodal arrhythmia - Sinus bradycardia | Cardiac disorders | — | — |
| Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity, cutaneous striae) | Endocrine disorders | — | — |
| Peripheral arterial ischemia | Vascular disorders | — | — |
| Rash: dermatitis associated with radiation - Radiation | Skin and subcutaneous tissue disorders | — | — |
| Taste alteration (dysgeusia) | Gastrointestinal disorders | — | — |
| Hemorrhoids | Gastrointestinal disorders | — | — |
| Mucositis/stomatitis (clinical exam) - Oral cavity | Gastrointestinal disorders | — | — |
| Weight gain | General disorders | — | — |
Most-reported serious reactions: Dehydration, Peripheral arterial ischemia, Renal failure, Obstruction, GU - Ureter, Fracture, Infection with unknown ANC - Bladder (urinary), Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS, Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary).
Data from ClinicalTrials.gov NCT01036594 adverse events section.
This is an open label, phase II, single center trial of ketoconazole/dexamethasone to determine if the administration of ketoconazole/dexamethasone, after disease progression with ketoconazole/hydrocortisone slows or reverses disease progression in men with progressive prostate cancer.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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