Zoledronate in Preventing Osteoporosis and Bone Fractures in Patients With Locally Advanced Nonmetastatic Prostate Cancer Undergoing Radiation Therapy and Hormone Therapy
2017年10月23日 更新者：Radiation Therapy Oncology Group
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.
調査の概要
状態
完了
詳細な説明
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.
研究の種類
介入
入学 (実際)
109
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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Chico、California、アメリカ、95926
- Enloe Cancer Center at Enloe Medical Center
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Los Angeles、California、アメリカ、90089-9181
- USC/Norris Comprehensive Cancer Center and Hospital
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Pomona、California、アメリカ、91767
- Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
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Roseville、California、アメリカ、95661
- Radiation Oncology Center - Roseville
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Sacramento、California、アメリカ、95815
- Radiological Associates of Sacramento Medical Group, Incorporated
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Colorado
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Colorado Springs、Colorado、アメリカ、80933
- Penrose Cancer Center at Penrose Hospital
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Pueblo、Colorado、アメリカ、81004
- St. Mary - Corwin Regional Medical Center
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-
Georgia
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Gainesville、Georgia、アメリカ、30501
- Northeast Georgia Medical Center
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-
Illinois
-
Alton、Illinois、アメリカ、62002
- Saint Anthony's Hospital at Saint Anthony's Health Center
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Arlington Heights、Illinois、アメリカ、60005
- Northwest Community Hospital
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Harvey、Illinois、アメリカ、60426
- Ingalls Cancer Care Center at Ingalls Memorial Hospital
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Olympia Fields、Illinois、アメリカ、60461
- Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
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Urbana、Illinois、アメリカ、61801
- CCOP - Carle Cancer Center
-
-
Indiana
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Goshen、Indiana、アメリカ、46526
- Center for Cancer Care at Goshen General Hospital
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Indianapolis、Indiana、アメリカ、46202
- Methodist Cancer Center at Methodist Hospital
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-
Kentucky
-
Lexington、Kentucky、アメリカ、40536-0093
- Lucille P. Markey Cancer Center at University of Kentucky
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-
Maryland
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Baltimore、Maryland、アメリカ、21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore、Maryland、アメリカ、21229
- St. Agnes Hospital Cancer Center
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Michigan
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Detroit、Michigan、アメリカ、48202
- Josephine Ford Cancer Center at Henry Ford Hospital
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Detroit、Michigan、アメリカ、48201-1379
- Barbara Ann Karmanos Cancer Institute
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Kalamazoo、Michigan、アメリカ、49007-3731
- West Michigan Cancer Center
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Minnesota
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Saint Cloud、Minnesota、アメリカ、56303
- CentraCare Clinic - River Campus
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Saint Cloud、Minnesota、アメリカ、56303
- Coborn Cancer Center
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Missouri
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Cape Girardeau、Missouri、アメリカ、63701
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
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Kansas City、Missouri、アメリカ、64131
- CCOP - Kansas City
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Saint Louis、Missouri、アメリカ、63141
- CCOP - St. Louis-Cape Girardeau
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Saint Louis、Missouri、アメリカ、63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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Saint Louis、Missouri、アメリカ、63141
- David C. Pratt Cancer Center at St. John's Mercy
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Springfield、Missouri、アメリカ、65804
- St. John's Regional Health Center
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Springfield、Missouri、アメリカ、65807
- Hulston Cancer Center at Cox Medical Center South
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Montana
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Billings、Montana、アメリカ、59101
- CCOP - Montana Cancer Consortium
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Billings、Montana、アメリカ、59101
- Northern Rockies Radiation Oncology Center
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Great Falls、Montana、アメリカ、59405
- Great Falls Clinic - Main Facility
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Nevada
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Las Vegas、Nevada、アメリカ、89102
- University Medical Center of Southern Nevada
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Las Vegas、Nevada、アメリカ、89106
- CCOP - Nevada Cancer Research Foundation
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Reno、Nevada、アメリカ、89502
- Renown Institute for Cancer at Renown Regional Medical Center
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New Hampshire
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Keene、New Hampshire、アメリカ、03431
- Kingsbury Center for Cancer Care at Cheshire Medical Center
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Lebanon、New Hampshire、アメリカ、03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Camden、New Jersey、アメリカ、08103
- Cancer Institute of New Jersey at Cooper University Hospital - Camden
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Vineland、New Jersey、アメリカ、08360
- Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
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Voorhees、New Jersey、アメリカ、08043
- Cancer Institute of New Jersey at Cooper - Voorhees
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New York
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Binghamton、New York、アメリカ、13905
- Lourdes Regional Cancer Center
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Brooklyn、New York、アメリカ、11209
- Veterans Affairs Medical Center - Brooklyn
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Buffalo、New York、アメリカ、14263-0001
- Roswell Park Cancer Institute
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East Syracuse、New York、アメリカ、13057
- CCOP - Hematology-Oncology Associates of Central New York
-
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North Carolina
-
Asheville、North Carolina、アメリカ、28801
- Mission Hospitals - Memorial Campus
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Goldsboro、North Carolina、アメリカ、27534
- Wayne Radiation Oncology
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Raleigh、North Carolina、アメリカ、27607
- Cancer Centers of North Carolina - Raleigh
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Wilson、North Carolina、アメリカ、27893
- Wilmed Radiation Oncology Services
-
-
Ohio
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Akron、Ohio、アメリカ、44307
- McDowell Cancer Center at Akron General Medical Center
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Akron、Ohio、アメリカ、44309-2090
- Summa Center for Cancer Care at Akron City Hospital
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Cincinnati、Ohio、アメリカ、45267
- Charles M. Barrett Cancer Center at University Hospital
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Salem、Ohio、アメリカ、44460
- Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
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West Chester、Ohio、アメリカ、45069
- Precision Radiotherapy at University Pointe
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Wooster、Ohio、アメリカ、44691
- Cancer Treatment Center
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Pennsylvania
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Abington、Pennsylvania、アメリカ、19001
- Rosenfeld Cancer Center at Abington Memorial Hospital
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Bryn Mawr、Pennsylvania、アメリカ、19010
- Bryn Mawr Hospital
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Gettysburg、Pennsylvania、アメリカ、17325
- Adams Cancer Center
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Paoli、Pennsylvania、アメリカ、19301-1792
- Cancer Center of Paoli Memorial Hospital
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Philadelphia、Pennsylvania、アメリカ、19111-2497
- Fox Chase Cancer Center - Philadelphia
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Wynnewood、Pennsylvania、アメリカ、19096
- Lankenau Cancer Center at Lankenau Hospital
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York、Pennsylvania、アメリカ、17405
- York Cancer Center at Apple Hill Medical Center
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Tennessee
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Kingsport、Tennessee、アメリカ、37662
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
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Utah
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Murray、Utah、アメリカ、84157
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
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Ogden、Utah、アメリカ、84403
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
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Provo、Utah、アメリカ、84604
- Utah Valley Regional Medical Center - Provo
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Saint George、Utah、アメリカ、84770
- Dixie Regional Medical Center - East Campus
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Salt Lake City、Utah、アメリカ、84143
- LDS Hospital
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Vermont
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Saint Johnsbury、Vermont、アメリカ、05819
- Norris Cotton Cancer Center - North
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Virginia
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Norfolk、Virginia、アメリカ、23507
- Sentara Cancer Institute at Sentara Norfolk General Hospital
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Portsmouth、Virginia、アメリカ、23708-2197
- Naval Medical Center - Portsmouth
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Washington
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Yakima、Washington、アメリカ、98902
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
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Wisconsin
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Appleton、Wisconsin、アメリカ、54911
- Theda Care Cancer Institute
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Green Bay、Wisconsin、アメリカ、54307-3508
- St. Vincent Hospital Regional Cancer Center
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Marinette、Wisconsin、アメリカ、54143
- Bay Area Cancer Care Center at Bay Area Medical Center
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Menomonee Falls、Wisconsin、アメリカ、53051
- Community Memorial Hospital Cancer Care Center
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Milwaukee、Wisconsin、アメリカ、53226
- Medical College of Wisconsin Cancer Center
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Milwaukee、Wisconsin、アメリカ、53295
- Veterans Affairs Medical Center - Milwaukee
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Milwaukee、Wisconsin、アメリカ、53215
- Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
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West Allis、Wisconsin、アメリカ、53227
- West Allis Memorial Hospital
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British Columbia
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Victoria、British Columbia、カナダ、V8R 6V5
- British Columbia Cancer Agency - Vancouver Island Centre
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Newfoundland and Labrador
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St. John's、Newfoundland and Labrador、カナダ、A1B 3V6
- Doctor H. Bliss Murphy Cancer Centre
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Ontario
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Hamilton、Ontario、カナダ、L8V 5C2
- Margaret and Charles Juravinski Cancer Centre
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Thunder Bay、Ontario、カナダ、P7B 6V4
- Cancer Care Program at Thunder Bay Regional Health Sciences
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Quebec
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Montreal、Quebec、カナダ、H1T 2M4
- Maisonneuve-Rosemont Hospital
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Quebec City、Quebec、カナダ、G1R 2J6
- Centre Hospitalier Universitaire de Quebec
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Sherbrooke、Quebec、カナダ、J1H 5N4
- CHUS-Hopital Fleurimont
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Saskatchewan
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Regina、Saskatchewan、カナダ、S4T 7T1
- Allan Blair Cancer Centre at Pasqua Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
男
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Zoledronic Acid
Zoledronic acid q 6 months plus Vitamin D and calcium supplement for 3 years in addition to concurrent radiation therapy and LHRH therapy.
|
A single dose of 500 mg of elemental calcium orally each day for 3 years.
Patients receive IV over 15 minutes once every 6 months for 3 years.
The goal dose of zoledronic acid is 4 mg, but the selection of dose is determined based on calculated creatinine clearance at baseline.
他の名前：
Patients must receive external beam irradiation, brachytherapy (HDR or LDR), or a combination of external beam irradiation and brachytherapy at the discretion of the treating physician.
Dose/duration also will be at the discretion of the treating physician; however, dose will not exceed 45 Gy to 100% of the proximal femur, and no proximal femur will receive ≥ 60 Gy.
LHRH therapy must take place for a minimum of one year.
Choice of LHRH agonist, dose, and duration are at the discretion of the treating physician.
400 IU (10μg), orally each day for 3 years.
|
|
アクティブコンパレータ：Control
Vitamin D and calcium supplement everyday for 3 years in addition to concurrent radiation therapy and LHRH therapy.
|
A single dose of 500 mg of elemental calcium orally each day for 3 years.
Patients must receive external beam irradiation, brachytherapy (HDR or LDR), or a combination of external beam irradiation and brachytherapy at the discretion of the treating physician.
Dose/duration also will be at the discretion of the treating physician; however, dose will not exceed 45 Gy to 100% of the proximal femur, and no proximal femur will receive ≥ 60 Gy.
LHRH therapy must take place for a minimum of one year.
Choice of LHRH agonist, dose, and duration are at the discretion of the treating physician.
400 IU (10μg), orally each day for 3 years.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Freedom From Any Bone Fracture (FABF) Rate at Three Years
時間枠：From randomization to 3 years
|
The time of failure was measured from the date of randomization to the date of documented bone fractures, defined as any fracture of the bone.
The three-year FABF rate will be estimated by the Kaplan-Meier method.
|
From randomization to 3 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percent Change in Bone Mineral Density at 3 Years
時間枠：Baseline, 3 years from start of treatment
|
Bone mineral density (BMD) was measured by DXA scan (Dual X-ray absorptiometry) for five locations: lumbar, right total hip, left total hip, right femoral neck, and left femoral neck.
The percent change at 3 years was calculated for each location by the following formula: Percent Change BMD = (BMD_3 years - BMD_Baseline)/ BMD_Baseline * 100.
|
Baseline, 3 years from start of treatment
|
|
Changes in the Functional Assessment of Cancer Therapy-General (FACT-G) at 3 Years
時間枠：Baseline, 3 years from start of treatment
|
The FACT-G is a validated, 27-item measure.
In addition to a total QOL score, subscale scores for physical, functional, social and emotional well-being are produced.
There are 5 responses options, with 0=Not a lot and 4=Very much.
All items in a subscale are added together, multiplied by the number of items in the subscale, then divided by the number of items answered to obtain subscale totals.
Scores range from 0-108 for the FACT-G total score, 0-28 for the physical, social and functional subscales, and 0-24 for the emotional subscale.
Certain items, identified on the FACT-G scoring guides, must be reversed before it is added by subtracting the response from 4. All subscale totals are added together to form the FACT-G total score.
Each subscale requires at least 50% of the items to be completed while the overall response rate must be greater than 80%.
If items are missing, the subscale scores can be prorated.
A higher score indicates better QOL.
|
Baseline, 3 years from start of treatment
|
|
Utility of the Use of Bisphosphonates as Assessed by Quality-adjusted Survival
時間枠：From pre-treatment to 3 years from start of treatment
|
The EQ-5D is a standardized instrument for measuring generic health status used to generate health utilities, used to derive quality adjusted survival.
Quality adjusted survival is computed using the weighted sum of times in different health states added up to a total quality-adjusted survival time.
The log-rank test is used to compare quality-adjusted survivals between the treatment arms.
|
From pre-treatment to 3 years from start of treatment
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Colleen A. Lawton, MD、Medical College of Wisconsin
- スタディチェア：Matthew R. Smith, MD、Massachusetts General Hospital
- スタディチェア：Margaret Chamberlain-Wilmoth, PhD, MSS, RN、Carolinas Medical Center - University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2006年3月1日
一次修了 (実際)
2014年11月1日
研究の完了 (実際)
2014年11月1日
試験登録日
最初に提出
2006年5月23日
QC基準を満たした最初の提出物
2006年5月23日
最初の投稿 (見積もり)
2006年5月25日
学習記録の更新
投稿された最後の更新 (実際)
2017年11月29日
QC基準を満たした最後の更新が送信されました
2017年10月23日
最終確認日
2017年10月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- RTOG 0518
- CDR0000476469
- NCI-2009-00884 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。