Clinical trial · Interventional
Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
Phase II Study of Weekly Intravenous 1,25 Dihydroxycholecelciferol (Calcitriol) + Dexamethasone in Androgen Independent Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): closed due to futility
Summary
Brief summary (as posted)
RATIONALE: Calcitriol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. Dexamethasone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with dexamethasone may be an effective treatment for prostate cancer that did not respond to hormone therapy . PURPOSE: This phase II trial is studying how well giving calcitriol together with dexamethasone works in treating patients with prostate cancer that did not respond to hormone therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| calcitriol | Dietary Supplement | — | UNRESOLVED |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| protein expression analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dexamethasone and Calcitriol
- description
- Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.
- interventionNames
- Dietary Supplement: calcitriol
- Drug: dexamethasone
- Genetic: protein expression analysis
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Objective Response (Complete or Partial Response)
- timeFrame
- 1 year
- description
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* History of androgen-independent prostate cancer
* Evidence of rising PSA level (with or without new lesion by radiograph or physical examination), defined as follows:
* PSA level \> 5 ng/mL and clearly rising on 2 measurements taken ≥ 2 weeks apart after androgen deprivation therapy (i.e., orchiectomy or luteinizing hormone-releasing hormone \[LHRH\] analogue) and antiandrogen withdrawal, if appropriate
* PSA rising before and on the first value taken at 4 or 6 weeks after antiandrogen cessation is considered disease progression
* Measurable or evaluable disease as defined by any of the following:
* Measurable or evaluable tumor masses by radiograph or physical examination
* Evaluable PSA
* Concurrent LHRH analogue or diethylstilbestrol (DES) for testicular androgen suppression required if no prior bilateral orchiectomy
* Patients receiving other monotherapy for testicular androgen suppression must switch to a LHRH analogue or DES ≥ 14 days prior to study entry
PATIENT CHARACTERISTICS:
* ECOG 0-2
* Life expectancy ≥ 12 weeks
* ANC ≥ 1,000/mm³
* Platelet count ≥ 75,000/mm³
* Hemoglobin \> 8.9 g/dL (transfusion or erythropoietin support allowed)
* Serum creatinine ≤ 1.8 mg/dL
* AST ≤ 4 times upper limit of normal (ULN)
* Total bilirubin ≤ 2.0 mg/dL
* Serum corrected calcium \< ULN
* No history of nephrolithiasis within the past 5 years
* No unstable, uncontrolled peptic ulcer disease, congestive heart failure, glaucoma, HIV, or diabetes
PRIOR CONCURRENT THERAPY:
* At least 28 days since prior androgen deprivation therapy (≥ 42 days for bicalutamide)
* A 28-day washout period is not required for patients who have previously progressed despite antiandrogen withdrawal and who have resumed antiandrogens without reduction of PSA
* At least 14 days since prior radiotherapy
* At least 28 days since prior strontium 89
* At least 28 days since prior chemotherapy and/or investigational agents
* No concurrent medications or supplements that contain additional calcium (e.g., Tums)
* No concurrent radiotherapy for pain control or any other indication
* Concurrent bisphosphonates allowed provided dose/regimen is stableReferences
Publications (0)
Data not yet available