Calcitriol and Dexamethasone Before Radical Prostatectomy in Treating Patients With Localized Adenocarcinoma (Cancer) of the Prostate

This study has been terminated.
(sample size is too small to draw a conclusion)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00084864
First received: June 10, 2004
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Dietary Supplement: calcitriol
Drug: dexamethasone
Other: clinical observation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Trial of Calcitriol in Localized Prostate Cancer: Investigation of Biologic Effects and Potential Intermediate Endpoints

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Effect of preoperative high-dose calcitriol and dexamethasone on prostatic tumor vessel density measured at 1, 2, 3, and 12 months post prostatectomy [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of preoperative high-dose calcitriol and dexamethasone on extent of prostatic intraepithelial neoplasia (PIN) at 1, 2, 3, and 12 months post prostatectomy [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: September 2002
Study Completion Date: May 2010
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stage 1, 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.
Dietary Supplement: calcitriol
Given orally
Drug: dexamethasone
Given orally
Experimental: Stage 1, Arm II
No study drugs before surgery.
Other: clinical observation
No intervention before surgery
Experimental: Stage 2, Arm I
Patients receive dexamethasone and calcitriol as in stage 1, arm I.
Dietary Supplement: calcitriol
Given orally
Drug: dexamethasone
Given orally
Experimental: Stage 2, Arm II
Patients receive oral dexamethasone once daily on days 1-4.
Drug: dexamethasone
Given orally
Experimental: Stage 2, Arm III
Patients receive oral calcitriol once daily on days 2-4.
Dietary Supplement: calcitriol
Given orally
Experimental: Stage 2, Arm IV
Patients do not receive study drugs before surgery as in stage 1, arm II.
Other: clinical observation
No intervention before surgery

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00084864

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Donald L. Trump, MD Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00084864     History of Changes
Other Study ID Numbers: CDR0000365693, P30CA016056, RPCI-RP-0212
Study First Received: June 10, 2004
Last Updated: December 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
adenocarcinoma of the prostate
stage II prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Prostatic Diseases
Urogenital Neoplasms
BB 1101
Calcitriol
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Bone Density Conservation Agents
Calcium Channel Agonists
Cardiovascular Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Growth Substances
Hormones

ClinicalTrials.gov processed this record on October 29, 2014