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

Sponsors and Collaborators:	Roswell Park Cancer Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00084864

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	Drug: calcitriol Drug: dexamethasone Procedure: observation	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Calcitriol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Pilot Trial of Calcitriol in Localized Prostate Cancer: Investigation of Biologic Effects and Potential Intermediate Endpoints

Further study details as provided by National Cancer Institute (NCI):

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 ]

Estimated Enrollment:	80
Study Start Date:	September 2002
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Stage 1, Arm I: Experimental 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.	Drug: calcitriol Given orally Drug: dexamethasone Given orally
Stage 1, Arm II: No Intervention No study drugs before surgery.	Procedure: observation No intervention before surgery
Stage 2, Arm I: Experimental Patients receive dexamethasone and calcitriol as in stage 1, arm I.	Drug: calcitriol Given orally Drug: dexamethasone Given orally
Stage 2, Arm II: Experimental Patients receive oral dexamethasone once daily on days 1-4.	Drug: dexamethasone Given orally
Stage 2, Arm III: Experimental Patients receive oral calcitriol once daily on days 2-4.	Drug: calcitriol Given orally
Stage 2, Arm IV: Experimental Patients do not receive study drugs before surgery as in stage 1, arm II.	Procedure: 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

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

Locations

United States, New York
Roswell Park Cancer Institute	Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724

Sponsors and Collaborators

Roswell Park Cancer Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Donald L. Trump, MD

Roswell Park Cancer Institute

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000365693, RPCI-RP-0212
Study First Received:	June 10, 2004
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00084864
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
stage II prostate cancer
stage III prostate cancer

Study placed in the following topic categories:

Dexamethasone
Calcium, Dietary
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male

Adenocarcinoma
Prostatic Neoplasms
Dexamethasone acetate
Calcitriol
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Calcium Channel Agonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Bone Density Conservation Agents
Hormones
Membrane Transport Modulators
Neoplasms by Site
Vitamins
Therapeutic Uses

Vasoconstrictor Agents
Micronutrients
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Growth Substances
Gastrointestinal Agents
Cardiovascular Agents
Glucocorticoids
Pharmacologic Actions
Neoplasms
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009