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A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Ability of Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy: Hoosier Oncology Group GU02-41


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

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Trial Information

A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Ability of Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy: Hoosier Oncology Group GU02-41


OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter, 2 arm study.

The study population will consist of prostate cancer patients with metastatic bone disease
for whom androgen-deprivation therapy is planned. After stratification based on the
patient's age, performance status, and severity of metastatic disease, the patients will be
randomized at a 1:1 ratio to the following treatment arms:

- Daily oral risedronate combined with androgen deprivation

- Daily oral placebo combined with androgen deprivation

Initial clinical evaluation will be performed during the 2-week screening period. While
patients receive per-protocol treatment, study assessments will be performed every 4 weeks
during the first 3 months, and every 12 weeks thereafter.

Performance Status: ECOG 0 to 2

Life Expectancy: At least 12 weeks

Hematopoietic:

- ANC > 1,000/mm3

- Platelet count > 100,000/mm3

- INR < 1.5 x upper limit of normal unless on therapeutic anticoagulation

- Partial thromboplastin time (PTT) < 1.5 x upper limit of normal unless on therapeutic
anticoagulation

Hepatic:

- Bilirubin < 1.5 mg/dL

- Alanine transaminase (ALT) < 2.5 x upper limit of normal

Renal:

- Creatinine clearance of > 30 mL/min (by Cockcroft-Gault)

Cardiovascular:

- No significant history of uncontrolled cardiac disease (i.e., uncontrolled
hypertension, unstable angina, and congestive heart failure).

Pulmonary:

- Not specified

Calcium:

- Corrected serum calcium = (4.0 g/dL - actual albumin g/dL)x 0.8 + serum calcium


Inclusion Criteria:



- Histologically or cytologically confirmed adenocarcinoma of the prostate with
metastatic bone disease (by CT, MRI or bone scan) with plans to start or be < 30 days
from beginning androgen deprivation therapy. Patients with lymph node or visceral
metastases only are not eligible

- Patients may receive palliative radiation therapy at the investigators discretion
during the first 4 weeks of beginning protocol therapy.

Exclusion Criteria:

- No neuroendocrine, small cell or transitional cell cancer of the prostate No abnormal
bone metabolism (i.e., Paget's disease, untreated hyperthyroidism, untreated
hyperprolactinemia, untreated Cushing's disease).

- No use of calcitonin within 14 days before being registered for protocol therapy or
any previous use of bisphosphonates.

- No major surgery within 4 weeks of registration to protocol therapy.

- No adjuvant chemotherapy within 6 months of registration to protocol therapy.

- No previous chemotherapy for metastatic disease.

- No hormonal therapy in the adjuvant setting within 12 months of registration to
protocol therapy; previous hormonal therapy must not have exceeded 6 months.

- No prior history of malignancy in the past 5 years with the exception of basal cell
and squamous cell carcinoma of the skin.

- No history of allergy or drug reactions to bisphosphonates.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate the ability of risedronate to prevent skeletal complications

Outcome Time Frame:

36 months

Safety Issue:

No

Principal Investigator

Christopher Sweeney, M.B.B.S.

Investigator Role:

Study Chair

Investigator Affiliation:

Hoosier Oncology Group, LLC

Authority:

United States: Food and Drug Administration

Study ID:

HOG GU02-41

NCT ID:

NCT00216060

Start Date:

October 2003

Completion Date:

March 2008

Related Keywords:

  • Metastatic Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Peoria Urological AssociatesPeoria, Illinois  61614
San Bernadino Urological AssociatesSan Bernadino, California  92404
Siteman Cancer CenterSaint Louis, Missouri  63110
Center for Cancer Care at Goshen Health SystemGoshen, Indiana  46526
Urology of Indiana, LLCIndianapolis, Indiana  46202
Center for Urological ResearchLa Mesa, California  91942
Drs. Werner, Murdock and Francis PA Urology AssociatesGreenbelt, Maryland  20770
Kansas City Urology CareKansas City, Missouri  64131
AccuMed Research AssociatesGarden City, New York  11530
Oregon Urology SpecialistsEugene, Oregon  97401
Urological Associates Of LancasterLancaster, Pennsylvania  17604-3200
Salt Lake ResearchSalt Lake City, Utah  84124
Lawrenceville UrologyLawrenceville, New Jersey  08648
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Triangle Urological GroupPittsburgh, Pennsylvania  15212
Mayo Clinic RochesterRochester, Minnesota  55905
Medical & Surgical Specialists, LLCGalesburg, Illinois  61401
Oncology Hematology Associates of SW IndianaEvansville, Indiana  47714
Quality Cancer Center (MCGOP)Indianapolis, Indiana  46202
Grove Hill Medical Center UrologyNew Britain, Connecticut  06052
Innovative Surgical ResourcesTampa, Florida  33607
Urology AssociatesMuncie, Indiana  47303
Urologic Surgery AssociatesBaltimore, Maryland  21201
Nevada UrologyReno, Nevada  89511
Staten Island Urological Research, P.C.Staten Island, New York  10304
David Reed, M.D.Seattle, Washington  98166
Madigan Army Medical Center Urology ServiceTacoma, Washington  98431