Zoledronate Plus Standard Therapy Compared With Placebo Plus Standard Therapy to Prevent Bone Metastases in Patients With Recurrent Prostate Cancer That Has No Symptoms

NCT00005073 | Terminated Phase 3

• 4 other identifiers: NOVARTIS-CZOL4460704UCLA-9908030CDR0000067678NCI-G00-1722
• Study Type: interventional
• Target: 544
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Zoledronate may be able to prevent bone metastases caused by prostate cancer. It is not yet known if zoledronate is effective in preventing the spread of prostate cancer to the bones. PURPOSE: Randomized phase III trial to determine the effectiveness of zoledronate plus standard therapy in preventing bone metastases in patients who have recurrent prostate cancer that is not causing symptoms.

Conditions

Prostate Cancer

Keywords

stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; recurrent prostate cancer

Interventions

zoledronic acid DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically proven asymptomatic recurrent prostate cancer Prior local treatment status Curatively treated OR Locally advanced disease noncuratively treated with LHRH agonist therapy Currently receiving 1 line of hormonal therapy (with LHRH agonists or surgical castration) and failing treatment with rising PSA only Patients who received LHRH agonists instead of surgical castration continue to receive LHRH agonist during study Biochemical progression documented by 3 consecutively rising PSA measurements, each at least 2 weeks apart, with the last measurement being 50% or greater than the nadir PSA achieved after the last therapeutic maneuver (first line hormonal therapy as noted above) PSA (50% increased values) greater than 4 ng/mL for patients with intact prostates and greater than 0.8 ng/mL for post-prostatectomy patients Rising PSA for less than 10 months Castrate levels of testosterone (less than 30 ng/dL) No bone or visceral metastases by bone scan and CT scan of abdomen and pelvis (except localized abnormalities and pelvic lymph node and soft tissue disease) No CNS or leptomeningeal involvement PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 90-100% Life expectancy: Greater than 6 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Hemoglobin at least 8.0 g/dL Platelet count at least 75,000/mm3 Hepatic: Liver function tests no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease with uncontrolled and/or unstable cardiac or coronary artery disease Other: No other malignancy within the past 5 years that would confound the etiology of metastatic disease except curatively treated nonmelanomatous skin cancer No other nonmalignant disease that would confound evaluation or preclude compliance Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior systemic biologic anticancer therapy Chemotherapy: No prior chemotherapy Concurrent chemotherapy such as estramustine containing regimens or mitoxantrone allowed at the discretion of the protocol investigator Endocrine therapy: See Disease Characteristics No prior systemic hormonal anticancer therapy except LHRH antagonists and/or nonsteroidal antiandrogens (e.g., flutamide, bicalutamide, or nilutamide) Concurrent aminoglutethimide, prednisone, or diethylstilbestrol or other estrogens allowed at the discretion of the protocol investigator Radiotherapy: At least 6 weeks since prior palliative radiotherapy Surgery: See Disease Characteristics Other: No other prior systemic anticancer therapy At least 4 weeks since other prior investigational drugs No other concurrent bisphosphonate agent

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Related Publications (1)

• Smith MR, Kabbinavar F, Saad F, Hussain A, Gittelman MC, Bilhartz DL, Wynne C, Murray R, Zinner NR, Schulman C, Linnartz R, Zheng M, Goessl C, Hei YJ, Small EJ, Cook R, Higano CS. Natural history of rising serum prostate-specific antigen in men with castrate nonmetastatic prostate cancer. J Clin Oncol. 2005 May 1;23(13):2918-25. doi: 10.1200/JCO.2005.01.529.

  PMID: 15860850 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Zoledronic Acid

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)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Fairooz F. Kabbinavar, MD

  Jonsson Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2000
• First Posted: June 18, 2004
• Study Start: September 1, 1999
• Primary Completion: March 1, 2003
• Study Completion: March 1, 2003
• Last Updated: May 1, 2013

Record last verified: 2013-04

Locations

US (1)