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

NCT00084864 | Terminated Phase 2 Results DMC

• 3 other identifiers: RP 02-12P30CA016056RPCI-RP-0212
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Effect of Preoperative High-dose Calcitriol and Dexamethasone on Prostatic Tumor Vessel Density Measured at 1, 2, 3, and 12 Months Post Prostatectomy

  Up to 30 days of the last administration of study procedure

Secondary Outcomes (4)

• Effect of Preoperative High-dose Calcitriol and Dexamethasone on Extent of Prostatic Intraepithelial Neoplasia (PIN) at 1, 2, 3, and 12 Months Post Prostatectomy

  Up to 30 days of the last administration of study procedure

• Determine the Effect of This Regimen on the Expression of Apoptosis Markers

  Up to 30 days of the last administration of study procedure

• Determine the Acute Effects of This Regimen on Serum PSA in These Patients.

  Up to 30 days of the last administration of study procedure

• Number of Participants With Adverse Events, Graded According to NCI CTCAE v2.0

  Up to 30 days of the last administration of study procedure

Study Arms (4)

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.

Dietary Supplement: calcitriol; Drug: dexamethasone

Stage 1, Arm II

EXPERIMENTAL

No study drugs before surgery.

Other: clinical observation

Stage 1 Arm 3

EXPERIMENTAL

Patients receive oral dexamethasone once daily on days 1-4.

Drug: dexamethasone

Stage 1, Arm 4

EXPERIMENTAL

Patients receive oral calcitriol once daily on days 2-4.

Dietary Supplement: calcitriol

Interventions

calcitriol DIETARY_SUPPLEMENT

Given orally

Stage 1, Arm 4; Stage 1, Arm I

dexamethasone DRUG

Given orally

Stage 1 Arm 3; Stage 1, Arm I

clinical observation OTHER

No intervention before surgery

Stage 1, Arm II

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Calcitriol; Dexamethasone; Watchful Waiting

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids, Fluorinated; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Limitations and Caveats

Study was activated prior to Roswell Park Cancer Institute (RPCI) putting a system in place to centralize data entry and data management. Data entry was done by PI's staff. PI left institute and left incomplete data.

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Donald L. Trump, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: September 1, 2002
• Primary Completion: February 1, 2010
• Study Completion: May 1, 2010
• Last Updated: June 12, 2017
• Results First Posted: June 12, 2017

Record last verified: 2017-05

Locations

US (1)