Clinical trial NCT00084864: Calcitriol and Dexamethasone Before Radical Prostatectomy in Treating Patients With Localized Adenocarcinoma (Cancer) of the Prostate
Official title: A Pilot Trial of Calcitriol in Localized Prostate Cancer: Investigation of Biologic Effects and Potential Intermediate Endpoints
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
stage II prostate cancer
stage III prostate cancer
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-06-11
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: OBJECTIVES:

* Determine the effect of calcitriol and dexamethasone before radical prostatectomy on tumor vessel density in patients with localized adenocarcinoma of the prostate.
* Determine the effect of this regimen on the extent of prostatic intraepithelial neoplasia in these patients.
* Determine the effect of this regimen on the expression of apoptosis markers, p21, p27, prostate-specific antigen (PSA), prostate-specific membrane antigen, and VDR expression in tumor-associated vascular endothelial cells and endothelium derived from normal-appearing prostate and tumor in these patients.
* Determine the acute effects of this regimen on serum PSA in these patients.
* Determine the toxicity of this regimen in these patients.

OUTLINE: This is a two-stage, randomized, pilot study.

* Stage 1: Patients are randomized to 1 of 2 treatment arms.

  * Arm I: 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. Within 48 hours of the last dose, patients undergo radical prostatectomy.
  * Arm II: Patients receive no study drugs, but undergo radical prostatectomy.
* Stage 2: If sufficient activity is seen with the dexamethasone and calcitriol regimen in stage 1, the study is expanded and additional patients are randomized to 1 of 4 treatment arms.

  * Arm I: Patients receive dexamethasone and calcitriol as in stage 1, arm I.
  * Arm II: Patients receive oral dexamethasone once daily on days 1-4.
  * Arm III: Patients receive oral calcitriol once daily on days 2-4.
  * Arm IV: Patients undergo radical prostatectomy as in stage 1, arm II. In arms I, II, and III, patients undergo radical prostatectomy as in stage 1, arm I.

Patients are followed at 1, 3, and 12 months.

PROJECTED ACCRUAL: A total of 20-80 patients (20 for stage 1 \[10 per treatment arm\] and 60 for stage 2) will be accrued for this study within 2 years.

Eligibility criteria: 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 prostate

Primary outcomes:
measure: Effect of Preoperative High-dose Calcitriol and Dexamethasone on Prostatic Tumor Vessel Density Measured at 1, 2, 3, and 12 Months Post Prostatectomy
timeFrame: Up to 30 days of the last administration of study procedure
Secondary outcomes:
measure: Effect of Preoperative High-dose Calcitriol and Dexamethasone on Extent of Prostatic Intraepithelial Neoplasia (PIN) at 1, 2, 3, and 12 Months Post Prostatectomy
timeFrame: Up to 30 days of the last administration of study procedure
measure: Determine the Effect of This Regimen on the Expression of Apoptosis Markers
timeFrame: Up to 30 days of the last administration of study procedure
measure: Determine the Acute Effects of This Regimen on Serum PSA in These Patients.
timeFrame: Up to 30 days of the last administration of study procedure
measure: Number of Participants With Adverse Events, Graded According to NCI CTCAE v2.0
timeFrame: Up to 30 days of the last administration of study procedure
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Donald L. Trump, MD
role: PRINCIPAL_INVESTIGATOR
References: