Clinical trial · Interventional
Calcitriol and Dexamethasone Before Radical Prostatectomy in Treating Patients With Localized Adenocarcinoma (Cancer) of the Prostate
A Pilot Trial of Calcitriol in Localized Prostate Cancer: Investigation of Biologic Effects and Potential Intermediate Endpoints
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): sample size is too small to draw a conclusion
Summary
Brief summary (as posted)
RATIONALE: Calcitriol and dexamethasone may slow the growth of prostate cancer cells. PURPOSE: This randomized phase II trial is studying how well giving calcitriol together with dexamethasone before radical prostatectomy works in treating patients with localized stage II or stage III adenocarcinoma (cancer) of the prostate.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| calcitriol | Dietary Supplement | — | UNRESOLVED |
| clinical observation | Other | — | UNRESOLVED |
| dexamethasone | Drug | Dexamethasone | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Stage 1, Arm I
- description
- Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.
- interventionNames
- Dietary Supplement: calcitriol
- Drug: dexamethasone
- type
- EXPERIMENTAL
- label
- Stage 1, Arm II
- description
- No study drugs before surgery.
- interventionNames
- Other: clinical observation
- type
- EXPERIMENTAL
- label
- Stage 1 Arm 3
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Organ-confined disease
* cT1, cT2, or cT3 tumors
* Patients with cT1 tumors are eligible if ≥ 1 core biopsies have ≥ 50% of the tumor OR if 50% of the cores examined contain the tumor
* No small cell carcinoma of the prostate
* Scheduled for radical prostatectomy
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Platelet count ≥ 100,000/mm\^3
* WBC ≥ 3,500/mm\^3
Hepatic
* ALT and AST ≤ 4 times normal
* Bilirubin ≤ 2 mg/dL
Renal
* Creatinine ≤ 2 times upper limit of normal
* Calcium ≤ 10.5 mg/dL
* No detectable renal stones by CT scan or ultrasound
Other
* No history of diabetes mellitus requiring pharmacotherapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* More than 5 years since prior antiestrogens, antiandrogens, luteinizing hormone-releasing hormone agonists, estrogen, or progestational agents
Radiotherapy
* Not specified
Surgery
* See Disease Characteristics
* No prior nephrectomy
* No prior prostatic surgery
* No prior cryotherapy or transurethral resection of the prostateReferences
Publications (0)
Data not yet available