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A Randomized Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men With Prostate Cancer Metastatic to Bone


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Metastatic Cancer, Prostate Cancer

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Trial Information

A Randomized Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men With Prostate Cancer Metastatic to Bone

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate

- No small cell, neuroendocrine, or transitional cell carcinomas

- At least 1 bone metastasis by bone scan, MRI, CT scan, or plain radiographs

- Indeterminate lesions should be confirmed by a second imaging method

- At least 1 bone metastasis with no prior irradiation

- Concurrent androgen deprivation therapy required, defined as any of the following:

- Bilateral orchiectomy

- Gonadotropin-releasing hormone (GnRH) agonist with or without an antiandrogen

PATIENT CHARACTERISTICS:

AGE

- 18 and over PERFORMANCE STATUS

- ECOG 0-2 LIFE EXPECTANCY

- Not specified HEMATOPOIETIC

- Not specified HEPATIC

- Not specified RENAL

- Creatinine clearance ≥ 30 mL/min

- Corrected calcium ≥ 8.0 mg/dL and < 11.6 mg/dL OTHER

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

BIOLOGIC THERAPY

- Concurrent standard biologic response modifiers allowed during open-label therapy
only CHEMOTHERAPY

- Concurrent standard cytotoxic chemotherapy allowed during open-label therapy only
ENDOCRINE THERAPY

- See Disease Characteristics

- Prior neoadjuvant and/or adjuvant hormonal therapy allowed provided duration of
therapy was no more than 6 months AND therapy was discontinued more than 6 months
before study entry

- No more than 6 months since initiation of any of the following hormonal therapies:

- Orchiectomy

- GnRH agonist (e.g., leuprolide, goserelin, or triptorelin)

- Estrogen therapy

- Antiandrogens (e.g., bicalutamide, flutamide, or nilutamide)

- Any other therapy known to lower testosterone levels or inhibit testosterone
effect

- No intermittent androgen deprivation therapy except for patients concurrently
enrolled on SWOG-9346

- Concurrent palliative corticosteroids allowed during open-label therapy only

- Concurrent standard hormonal agents allowed during open-label therapy only
RADIOTHERAPY

- See Disease Characteristics

- No prior radiopharmaceuticals

- At least 4 weeks since prior radiotherapy

- Concurrent standard radiotherapy to extraskeletal and/or skeletal tumor sites allowed
during open-label therapy only SURGERY

- See Disease Characteristics OTHER

- No prior bisphosphonates

- No other concurrent agents expected to alter osteoclast activity (e.g., calcitonin,
mithramycin, gallium nitrate, or any other bisphosphonate)

- Concurrent daily supplemental elemental calcium (500 mg) and a multivitamin
containing cholecalciferol (Vitamin D) (400 IU) OR a combination tablet containing
both recommended

- Concurrent standard marketed antineoplastic therapies allowed during open-label
therapy only

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Time to first skeletal related event

Outcome Time Frame:

Patients are followed periodically for approximately 10 years after randomization.

Safety Issue:

No

Principal Investigator

Matthew Smith, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Food and Drug Administration

Study ID:

0120070271

NCT ID:

NCT00698308

Start Date:

January 2004

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • Prostate Cancer
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Prostatic Neoplasms

Name

Location

University of Medicine and Dentistry of New JerseyNewark, New Jersey  07103-2425