Study Stopped
Terminated due to low accrual
Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy
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
1 other identifier
interventional
63
2 countries
45
Brief Summary
Risedronate is an orally administered pyridinyl bisphosphonate that is 36 times more potent than pamidronate and 72 times more potent than clodronate. Four randomized, double-blind trials have been carried out in patients with postmenopausal osteoporosis. In 2 of these studies, vertebral fracture incidence was reduced by a daily dose of 5 mg risedronate by up to 65% and 49% relative to placebo after 1 and 3 years, respectively. In these trials, risedronate improved lumbar spine, femoral neck, and femoral trochanter bone mineral density (BMD) at 6 months. In addition, preclinical studies have shown that risedronate is more potent than pamidronate and clodronate in inhibiting adhesion of prostate cancer cells to bone and preventing tumor cell invasion. The incidence of osteoporosis in prostate cancer patients has been well established; therefore, it is advantageous to assess the efficacy of oral bisphosphonate therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2003
Typical duration for phase_3
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedResults Posted
Study results publicly available
May 26, 2016
CompletedMay 26, 2016
May 1, 2016
4.3 years
September 13, 2005
January 5, 2016
May 25, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Numbers of SRE or Death Occurred Cumulatively
Number of participants experiencing a SRE(skeletal-related event) or death occurred, cumulative from each arm ( a daily oral dose of 30 mg risedronate, or placebo)
36 months
Secondary Outcomes (7)
Rate of Patients Archiving a PSA (Prostate Specific Antigen) Nadir < 0.2 ng/mL
36 months
Time to Development of Hormone Refractory Disease
36 months
Bone Turnover Marker Changes -- Urine Total Deoxypyridinoline (DPD)
24 weeks
Three- Year Survival Rate
36 months
Bone Turnover Marker Changes-- Urine N-telopeptide (NTX) Median
24 week
- +2 more secondary outcomes
Study Arms (2)
Experimental Arm
EXPERIMENTALDaily oral risedronate combined with androgen deprivation
Placebo Arm
PLACEBO COMPARATORdaily oral placebo combined with androgen deprivation
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Christopher Sweeney, MBBSlead
- Sanoficollaborator
- Walther Cancer Institutecollaborator
- Hoosier Cancer Research Networkcollaborator
Study Sites (45)
Center for Urological Research
La Mesa, California, 91942, United States
San Bernadino Urological Associates
San Bernardino, California, 92404, United States
Grove Hill Medical Center Urology
New Britain, Connecticut, 06052, United States
Innovative Surgical Resources
Tampa, Florida, 33607, United States
Medical & Surgical Specialists, LLC
Galesburg, Illinois, 61401, United States
Peoria Urological Associates
Peoria, Illinois, 61614, United States
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, 47714, United States
Center for Cancer Care at Goshen Health System
Goshen, Indiana, 46527, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202, United States
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, 46202, United States
Urology of Indiana, LLC
Indianapolis, Indiana, 46202, United States
Urology Associates
Muncie, Indiana, 47303, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601, United States
Urologic Surgery Associates
Baltimore, Maryland, 21201, United States
Drs. Werner, Murdock and Francis PA Urology Associates
Greenbelt, Maryland, 20770, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Kansas City Urology Care
Kansas City, Missouri, 64131, United States
Siteman Cancer Center
St Louis, Missouri, 63110, United States
Nevada Urology
Reno, Nevada, 89511, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Lawrenceville Urology
Trenton, New Jersey, 08648, United States
Accumed Research Associates
Garden City, New York, 11530, United States
Staten Island Urological Research, P.C.
Staten Island, New York, 10304, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Oregon Urology Specialists
Springfield, Oregon, 97477, United States
Urological Associates of Lancaster
Lancaster, Pennsylvania, 17604, United States
Triangle Urological Group
Pittsburgh, Pennsylvania, 15212, United States
Salt Lake Research
Salt Lake City, Utah, 84124, United States
David Reed, M.D.
Seattle, Washington, 98166, United States
Madigan Army Medical Center Urology Service
Tacoma, Washington, 98431, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Southern Interior Medical Research, Inc.
Kelowna, British Columbia, V1Y 2H4, Canada
Andreou Research
Surrey, British Columbia, V3W 1N1, Canada
Dr. G. Steinhoff Clinical Research
Victoria, British Columbia, V8V 3N1, Canada
Dr. Allan Patrick Professional Corporation
Fredericton, New Brunswick, E3B 5B8, Canada
Male/Female Health and Research
Barrie, Ontario, L4M 7G1, Canada
Burlington Professional Centre
Burlington, Ontario, L7N 3V2, Canada
Urology Resource Centre
Burlington, Ontario, L7S 1V2, Canada
Hamilton District Urology Research Center
Hamilton, Ontario, L8N 4A6, Canada
Centre for Advanced Urological Research
Kingston, Ontario, K7L-2V7, Canada
London Region Cancer Program
London, Ontario, N6A 4L6, Canada
MOR Urology, Inc.
Newmarket, Ontario, L3X 1W1, Canada
Male Health Centres
Oakville, Ontario, L6H 3P1, Canada
Scarborough General Hospital, Medical Mall
Scarborough Village, Ontario, M1P 2T7, Canada
University Health Network - Princess Margaret Division
Toronto, Ontario, M5G 2M9, Canada
Related Publications (3)
C. Sweeney, W. M. Dugan II, R. Dreicer, F. Chu, G. Parks, K. Baker, D. Reed, K. Jansz, J. Zadra, C. T. Yiannoutsos. J Clin Oncol 28, 2010 (suppl; abstr e15000)
RESULTJakob 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: 33270906DERIVEDHahn NM, Yiannoutsos CT, Kirkpatrick K, Sharma J, Sweeney CJ. Failure to suppress markers of bone turnover on first-line hormone therapy for metastatic prostate cancer is associated with shorter time to skeletal-related event. Clin Genitourin Cancer. 2014 Feb;12(1):33-40.e4. doi: 10.1016/j.clgc.2013.07.002. Epub 2013 Oct 12.
PMID: 24126237DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Christopher Sweeney, M.B., B.S.
- Organization
- Hoosier Oncology Group
Study Officials
- STUDY CHAIR
Christopher Sweeney, M.B.B.S.
Hoosier Oncology Group, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor-Investigator
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 22, 2005
Study Start
October 1, 2003
Primary Completion
February 1, 2008
Study Completion
March 1, 2008
Last Updated
May 26, 2016
Results First Posted
May 26, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share