Zoledronate in Preventing Osteoporosis and Bone Fractures in Patients With Locally Advanced Nonmetastatic Prostate Cancer Undergoing Radiation Therapy and Hormone Therapy
Status: | Completed |
---|---|
Conditions: | Prostate Cancer, Cancer, Osteoporosis |
Therapuetic Areas: | Oncology, Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/1/2017 |
Start Date: | March 2006 |
End Date: | November 2014 |
A Phase III Randomized Study to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer
RATIONALE: Zoledronate may prevent bone loss in patients with prostate cancer undergoing
radiation therapy and hormone therapy. It is not yet known whether zoledronate is more
effective than calcium and vitamin D alone in preventing osteoporosis and bone fractures in
patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works
compared to calcium and vitamin D alone in preventing osteoporosis and bone fractures in
patients with locally advanced nonmetastatic prostate cancer undergoing radiation therapy and
hormone therapy.
radiation therapy and hormone therapy. It is not yet known whether zoledronate is more
effective than calcium and vitamin D alone in preventing osteoporosis and bone fractures in
patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works
compared to calcium and vitamin D alone in preventing osteoporosis and bone fractures in
patients with locally advanced nonmetastatic prostate cancer undergoing radiation therapy and
hormone therapy.
OBJECTIVES:
Primary
- Compare the potential benefit of bisphosphonate therapy comprising zoledronate plus
vitamin D and calcium supplement vs standard therapy with vitamin D and calcium
supplement in the prevention of osteoporosis and associated bone fractures in patients
with locally advanced nonmetastatic adenocarcinoma of the prostate undergoing
radiotherapy and luteinizing hormone-releasing hormone (LHRH) agonist therapy.
Secondary
- Evaluate the potential benefit of these regimens on quality of life in these patients.
- Evaluate the potential benefit in bone mineral density over a period of 3 years for
patients treated with these regimens.
OUTLINE: This is randomized multicenter study. Patients are stratified according to T score
of the hip by dual x-ray absorptiometry (DXA) scan (< -1.0 but > -2.5 vs ≥ - 1.0) and planned
duration of luteinizing hormone-releasing hormone (LHRH) agonist therapy (1-2½ years vs > 2½
years). Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline and every 6 months during treatment.
Primary
- Compare the potential benefit of bisphosphonate therapy comprising zoledronate plus
vitamin D and calcium supplement vs standard therapy with vitamin D and calcium
supplement in the prevention of osteoporosis and associated bone fractures in patients
with locally advanced nonmetastatic adenocarcinoma of the prostate undergoing
radiotherapy and luteinizing hormone-releasing hormone (LHRH) agonist therapy.
Secondary
- Evaluate the potential benefit of these regimens on quality of life in these patients.
- Evaluate the potential benefit in bone mineral density over a period of 3 years for
patients treated with these regimens.
OUTLINE: This is randomized multicenter study. Patients are stratified according to T score
of the hip by dual x-ray absorptiometry (DXA) scan (< -1.0 but > -2.5 vs ≥ - 1.0) and planned
duration of luteinizing hormone-releasing hormone (LHRH) agonist therapy (1-2½ years vs > 2½
years). Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline and every 6 months during treatment.
Eligibility criteria:
- Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of
the prostate within 12 months of registration;
- Any one of the following clinical stages:
- T3 disease, any N stage, M0 with any Gleason score and any prostate-specific
antigen (PSA); < T3 stage, any N stage, M0 with Gleason's score ≥ 8 and any PSA;
< T3 stage, any N stage, M0 with Gleason's score 7 and PSA ≥ 15 nanograms/ml; <
T3 stage, any N stage, M0 with Gleason score < 7 and PSA ≥ 20 nanograms/ml.
- A negative bone scan for metastatic disease;
- It is mandatory that the treating physician determine the planned duration of LHRH
therapy prior to the site registering the patient (minimum 1 year of therapy); If
patient is receiving pre-treatment LHRH therapy, it must have begun ≤ 6 months prior
to registration. If pelvic radiation therapy (RT) has started, it must have begun ≤ 8
weeks prior to registration;
- Appropriate stage for protocol entry, including no distant metastases, based upon the
following minimum diagnostic workup to be done within 16 weeks prior to registration:
- History/physical examination;
- Dental evaluation, including history of dental surgery (e.g., extraction or implant);
- Bone scan;
- T and L spine films;
- DXA scan: To be eligible the patient must have a scan on Lunar, Hologic, or Norland
equipment only and the T scores in both the L spine and total hip must be > negative
2.5;
- Zubrod Performance Status 0-1 within 16 weeks prior to registration; (8/16/07)
- Age ≥ 18;
- Serum creatinine within 4 weeks prior to registration (8/16/07)
- Corrected serum calcium ≥ 8.4 and ≤ 10.6 mg/dl within 8 weeks prior to registration;
note: for patients with an albumin of 4.0, corrected calcium=measured calcium. The
formula for corrected calcium if serum albumin value is above or below 4.0 is as
follows: Corrected calcium (mg/dl) = (4 - [patient's albumin (g/dl)] x 0.8) +
patient's measured calcium (mg/dl)
- Patients who are sexually active must be willing/able to use medically acceptable
forms of contraception, as the treatment involved in this study may be significantly
teratogenic.
- Patient agrees to refrain from using all products listed in Section 9.2,
"Non-permitted Supportive Therapy";
- Post-prostatectomy patients are eligible.
- Patient must sign study specific informed consent prior to study entry.
Ineligibility criteria:
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
for a minimum of 3 years; e.g., carcinoma in situ of the breast or oral cavity are
permissible;
- Patients with baseline T scores of ≤ -2.5 are excluded.
- Patients with baseline calculated creatinine clearance < 30 mL/min (estimated by
Cockcroft-Gault formula below) are excluded. creatinine clearance male = [(140 - age)
x (wt in kg)] / [(serum creatinine) x (72)]
- Prior bisphosphonate therapy;
- Prior pelvic radiation (other than for current prostate cancer) or prior systemic
radiotherapeutic agents, such as strontium or samarium;
- Patients receiving systemic chemotherapy, steroids, growth hormones, or calcitonin;
- Patients with a history of Paget's disease or with uncontrolled thyroid or parathyroid
dysfunction or with other diseases that influence bone metabolism;
- Known hypersensitivity to zoledronic acid or other bisphosphonates;
- Active dental problems at study entry, including infection of the teeth or jawbone;
dental or fixture trauma; or a current or prior diagnosis of osteonecrosis of the jaw,
exposed bone in the mouth, or slow healing after dental procedures;
- Recent or planned
We found this trial at
81
sites
Bryn Mawr Hospital Bryn Mawr Hospital, a nationally recognized community teaching hospital, is conveniently located...
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1200 Old York Road
Abington, Pennsylvania 19001
Abington, Pennsylvania 19001
(215) 481-2400
Rosenfeld Cancer Center at Abington Memorial Hospital As one of the most trusted cancer centers...
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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1920 Libal Street
Green Bay, Wisconsin 54307
Green Bay, Wisconsin 54307
(920) 433-8889
St. Vincent Hospital Regional Cancer Center Our group of 19 oncologists, including the region's only...
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West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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1800 West Charleston Boulevard
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
(702) 383-2000
University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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One Medical Center Drive
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
(603) 653-9000
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Norris Cotton Cancer Center at DHMC in...
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800 Rose St
Lexington, Kentucky 40536
Lexington, Kentucky 40536
(859) 257-4488
Lucille P. Markey Cancer Center at University of Kentucky The Markey Cancer Center was founded...
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Naval Medical Center - Portsmouth Naval Medical Center Portsmouth, Virginia has proudly served the military...
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42 E Laurel Rd # 2545
Voorhees, New Jersey 08043
Voorhees, New Jersey 08043
(800) 826-6737
Cancer Institute of New Jersey at Cooper - Voorhees Cooper University Health Care, the clinical...
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161 North Forge Street
Akron, Ohio 44304
Akron, Ohio 44304
(330) 375-7280
Summa Center for Cancer Care at Akron City Hospital Summa Health System is a leader...
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1 Akron General Ave
Akron, Ohio 44307
Akron, Ohio 44307
(330) 344-6000
McDowell Cancer Center at Akron General Medical Center Learning that you or someone you love...
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St. Agnes Hospital Cancer Center Saint Agnes Hospital is leading Maryland in the battle against...
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Cape Girardeau, Missouri 63701
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2222 N. Nevada Avenue
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80907
(719) 776-5000
Penrose Cancer Center at Penrose Hospital Through a full range of clinical trials, genetic counseling,...
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2799 W Grand Blvd
Detroit, Michigan 48202
Detroit, Michigan 48202
(888) 777-4167
Josephine Ford Cancer Center at Henry Ford Hospital A diagnosis of cancer is one of...
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5008 Brittonfield Parkway
East Syracuse, New York 13057
East Syracuse, New York 13057
(315) 472-7504
CCOP - Hematology-Oncology Associates of Central New York Hematology/Oncology Associates of CNY (HOACNY) has participated...
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Northeast Georgia Medical Center Northeast Georgia Health System (NGHS) is a not-for-profit community health system...
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Adams Cancer Center Every day across central Pennsylvania, the people of WellSpan Health work together...
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One Ingalls Drive
Harvey, Illinois 60426
Harvey, Illinois 60426
708.333.2300
Ingalls Cancer Care Center at Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare...
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Kingsport, Tennessee 37662
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3100 Shore Dr.
Marinette, Wisconsin 54143
Marinette, Wisconsin 54143
715.735.6621
Bay Area Cancer Care Center at Bay Area Medical Center The Bay Area Cancer Care...
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8800 W. Doyne Avenue
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
(414) 805-6840
Medical College of Wisconsin Cancer Center Cancer touches everyone in our community, and for many,...
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5121 South Cottonwood Street
Murray, Utah 84157
Murray, Utah 84157
(801) 507-3800
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center The Jon and Karen Huntsman...
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Olympia Fields, Illinois 60461
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Pomona, California 91767
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Coborn Cancer Center CentraCare Health is a not-for-profit health care system that provides comprehensive, high-quality...
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CentraCare Clinic - River Campus CentraCare Health is a not-for-profit health care system that provides...
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1380 East Medical Center Drive
Saint George, Utah UT84790
Saint George, Utah UT84790
(435) 251-1000
Dixie Regional Medical Center - East Campus Dixie Regional has particularly been praised for excellent...
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607 S. New Ballas Road
Saint Louis, Missouri 63141
Saint Louis, Missouri 63141
(314) 251-4800
David C. Pratt Cancer Center at St. John's Mercy Many forms of cancer are more...
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Salem, Ohio 44460
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LDS Hospital LDS Hospital provides clinical excellence to our community in a wide range of...
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3850 S National Ave
Springfield, Missouri 65807
Springfield, Missouri 65807
(417) 269-5257
Hulston Cancer Center at Cox Medical Center South In 1997, the cancer program at CoxHealth...
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CCOP - Carle Cancer Center The Carle Cancer Center Community Clinical Oncology Program (CCOP) in...
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2410 Lee Avenue
Victoria, British Columbia V8R 6V5
Victoria, British Columbia V8R 6V5
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Vineland, New Jersey 08360
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100 E Lancaster Ave
Wynnewood, Pennsylvania 19096
Wynnewood, Pennsylvania 19096
(484) 476-2000
Lankenau Cancer Center at Lankenau Hospital At Lankenau we pride ourselves on the breadth of...
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