Androgen Blockade Therapy With or Without Zoledronic Acid in Treating Patients With Prostate Cancer and Bone Metastases

NCT00685646 | Completed Phase 3 DMC

• 2 other identifiers: TRIGU0705KYUH-TRIGU0705
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen blockade therapy may lessen the amount of androgens made by the body. Zoledronic acid may help relieve some of the symptoms caused by bone metastasis. It is not yet known whether androgen-blockade therapy is more effective with or without zoledronic acid in treating patients with prostate cancer that has spread to the bone. PURPOSE: This randomized phase III trial is studying androgen-blockade therapy given together with zoledronic acid to see how well it works compared with androgen-blockade therapy alone in treating patients with prostate cancer and bone metastases.

Conditions

Metastatic Cancer; Prostate Cancer

Keywords

bone metastases; stage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

• Time to treatment failure (TTF)

  The interval from the date of randomization to the earliest date on which prostate-specific antigen (PSA) progression, clinical progression, first skeletal-related events (SRE), death, or cessation of protocol treatment for any reason occurred.

  6 years

Secondary Outcomes (7)

• Time to first skeletal-related events (SRE)

  6 years

• Overall survival

  6 years

• Extent of disease on bone scan (EOD)

  Baseline, Month 12, 24 and 36

• Pain scale

  Baseline, Month 12, 24 and 36

• FACES pain-rating scale

  Baseline, Month 12, 24 and 36

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive maximum androgen-blockade therapy and zoledronic acid for up to 24 courses.

Drug: antiandrogen therapy; Drug: zoledronic acid

Arm II

ACTIVE COMPARATOR

Patients receive maximum androgen-blockade therapy for up to 24 courses.

Drug: antiandrogen therapy

Interventions

antiandrogen therapy DRUG

Up to 24 courses of therapy

Arm I; Arm II

zoledronic acid DRUG

Up to 24 courses of therapy

Arm I

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with definitive diagnosis of prostatic cancer by histopathological diagnosis or cytology
• Androgen blockade therapy-, systemic chemotherapy-, bisphosphonates-naïve prostatic cancer patients
• Patients who are sensitive to androgen blockade therapy
• Patients with bone metastasis on bone scan (EOD ≥ 1)
• Patients who have Eastern Cooperative Oncology Group performance status (ECOG: 0-2)
• Patients who have prostate-specific antigen performance status (PSA ≧30 ng/mL)
• Patients who demonstrate appropriate bone marrow, hepatic and renal functions in laboratory tests within four weeks before the registration.
• Leukocyte count ≥ 3,000/μL
• Hemoglobin ≥ 9.0 g/dL
• Platelet count ≥ 7.5 × 10\^4/μL
• Serum creatine level ≤ 3.0 mg/dL
• mg/dL ≤ corrected serum level of calcium ≤ 11.5 mg/dL
• Total bilirubin ≤ 1.8 mg/dL
• Aspartate aminotransferase (AST) Levels ≤ 90 IU/L
• Alanine aminotransferase (ALT) Levels ≤ 100 IU/L

You may not qualify if:

• Patients with poorly-controlled dental caries
• Patients with double cancer that requires treatment
• Patients who are using following steroid drugs (except for topical ointment)
• Patients with poorly-controlled hypertension or cardiovascular disease
• Patients with active infectious diseases or HIV or hepatitis virus infections
• Other patients whose participation in the present study is considered inappropriate by a Principal Investigator or Clinical Investigator
• PRIOR CONCURRENT THERAPY:
• No prior androgen-blockade therapy
• No prior or other concurrent anticancer therapy
• No prior or concurrent immunologic adjuvant therapy
• No prior or concurrent steroid drugs (except ointment)
• No other prior or concurrent bisphosphonates (excluding zoledronic acid)
• No prior systemic chemotherapy

Sponsors & Collaborators

• Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan: lead
• Kyoto University, Graduate School of Medicine: collaborator

Study Sites (1)

Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

Location

Related Publications (1)

• Jakob T, Tesfamariam YM, Macherey S, Kuhr K, Adams A, Monsef I, Heidenreich A, Skoetz N. Bisphosphonates or RANK-ligand-inhibitors for men with prostate cancer and bone metastases: a network meta-analysis. Cochrane Database Syst Rev. 2020 Dec 3;12(12):CD013020. doi: 10.1002/14651858.CD013020.pub2.

  PMID: 33270906 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis; Prostatic Neoplasms

Interventions

Androgen Antagonists; Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Osamu Ogawa, MD, Ph.D.

  Kyoto University, Graduate School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2008
• First Posted: May 28, 2008
• Study Start: May 1, 2008
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: October 16, 2015

Record last verified: 2015-10

Locations

JP (1)