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Zoledronate in Preventing Osteoporosis and Bone Fractures in Patients With Locally Advanced Nonmetastatic Prostate Cancer Undergoing Radiation Therapy and Hormone Therapy

23. října 2017 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

109

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Kanada
    • British Columbia
      • Victoria, British Columbia, Kanada, V8R 6V5
        • British Columbia Cancer Agency - Vancouver Island Centre
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Kanada, A1B 3V6
        • Doctor H. Bliss Murphy Cancer Centre
    • Ontario
      • Hamilton, Ontario, Kanada, L8V 5C2
        • Margaret and Charles Juravinski Cancer Centre
      • Thunder Bay, Ontario, Kanada, P7B 6V4
        • Cancer Care Program at Thunder Bay Regional Health Sciences
    • Quebec
      • Montreal, Quebec, Kanada, H1T 2M4
        • Maisonneuve-Rosemont Hospital
      • Quebec City, Quebec, Kanada, G1R 2J6
        • Centre Hospitalier Universitaire de Quebec
      • Sherbrooke, Quebec, Kanada, J1H 5N4
        • CHUS-Hopital Fleurimont
    • Saskatchewan
      • Regina, Saskatchewan, Kanada, S4T 7T1
        • Allan Blair Cancer Centre at Pasqua Hospital
  • Spojené státy
    • California
      • Chico, California, Spojené státy, 95926
        • Enloe Cancer Center at Enloe Medical Center
      • Los Angeles, California, Spojené státy, 90089-9181
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Pomona, California, Spojené státy, 91767
        • Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
      • Roseville, California, Spojené státy, 95661
        • Radiation Oncology Center - Roseville
      • Sacramento, California, Spojené státy, 95815
        • Radiological Associates of Sacramento Medical Group, Incorporated
    • Colorado
      • Colorado Springs, Colorado, Spojené státy, 80933
        • Penrose Cancer Center at Penrose Hospital
      • Pueblo, Colorado, Spojené státy, 81004
        • St. Mary - Corwin Regional Medical Center
    • Georgia
      • Gainesville, Georgia, Spojené státy, 30501
        • Northeast Georgia Medical Center
    • Illinois
      • Alton, Illinois, Spojené státy, 62002
        • Saint Anthony's Hospital at Saint Anthony's Health Center
      • Arlington Heights, Illinois, Spojené státy, 60005
        • Northwest Community Hospital
      • Harvey, Illinois, Spojené státy, 60426
        • Ingalls Cancer Care Center at Ingalls Memorial Hospital
      • Olympia Fields, Illinois, Spojené státy, 60461
        • Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
      • Urbana, Illinois, Spojené státy, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Goshen, Indiana, Spojené státy, 46526
        • Center for Cancer Care at Goshen General Hospital
      • Indianapolis, Indiana, Spojené státy, 46202
        • Methodist Cancer Center at Methodist Hospital
    • Kentucky
      • Lexington, Kentucky, Spojené státy, 40536-0093
        • Lucille P. Markey Cancer Center at University of Kentucky
    • Maryland
      • Baltimore, Maryland, Spojené státy, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
      • Baltimore, Maryland, Spojené státy, 21229
        • St. Agnes Hospital Cancer Center
    • Michigan
      • Detroit, Michigan, Spojené státy, 48202
        • Josephine Ford Cancer Center at Henry Ford Hospital
      • Detroit, Michigan, Spojené státy, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Kalamazoo, Michigan, Spojené státy, 49007-3731
        • West Michigan Cancer Center
    • Minnesota
      • Saint Cloud, Minnesota, Spojené státy, 56303
        • CentraCare Clinic - River Campus
      • Saint Cloud, Minnesota, Spojené státy, 56303
        • Coborn Cancer Center
    • Missouri
      • Cape Girardeau, Missouri, Spojené státy, 63701
        • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
      • Kansas City, Missouri, Spojené státy, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, Spojené státy, 63141
        • CCOP - St. Louis-Cape Girardeau
      • Saint Louis, Missouri, Spojené státy, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
      • Saint Louis, Missouri, Spojené státy, 63141
        • David C. Pratt Cancer Center at St. John's Mercy
      • Springfield, Missouri, Spojené státy, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, Spojené státy, 65807
        • Hulston Cancer Center at Cox Medical Center South
    • Montana
      • Billings, Montana, Spojené státy, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, Spojené státy, 59101
        • Northern Rockies Radiation Oncology Center
      • Great Falls, Montana, Spojené státy, 59405
        • Great Falls Clinic - Main Facility
    • Nevada
      • Las Vegas, Nevada, Spojené státy, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, Spojené státy, 89106
        • CCOP - Nevada Cancer Research Foundation
      • Reno, Nevada, Spojené státy, 89502
        • Renown Institute for Cancer at Renown Regional Medical Center
    • New Hampshire
      • Keene, New Hampshire, Spojené státy, 03431
        • Kingsbury Center for Cancer Care at Cheshire Medical Center
      • Lebanon, New Hampshire, Spojené státy, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Camden, New Jersey, Spojené státy, 08103
        • Cancer Institute of New Jersey at Cooper University Hospital - Camden
      • Vineland, New Jersey, Spojené státy, 08360
        • Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
      • Voorhees, New Jersey, Spojené státy, 08043
        • Cancer Institute of New Jersey at Cooper - Voorhees
    • New York
      • Binghamton, New York, Spojené státy, 13905
        • Lourdes Regional Cancer Center
      • Brooklyn, New York, Spojené státy, 11209
        • Veterans Affairs Medical Center - Brooklyn
      • Buffalo, New York, Spojené státy, 14263-0001
        • Roswell Park Cancer Institute
      • East Syracuse, New York, Spojené státy, 13057
        • CCOP - Hematology-Oncology Associates of Central New York
    • North Carolina
      • Asheville, North Carolina, Spojené státy, 28801
        • Mission Hospitals - Memorial Campus
      • Goldsboro, North Carolina, Spojené státy, 27534
        • Wayne Radiation Oncology
      • Raleigh, North Carolina, Spojené státy, 27607
        • Cancer Centers of North Carolina - Raleigh
      • Wilson, North Carolina, Spojené státy, 27893
        • Wilmed Radiation Oncology Services
    • Ohio
      • Akron, Ohio, Spojené státy, 44307
        • McDowell Cancer Center at Akron General Medical Center
      • Akron, Ohio, Spojené státy, 44309-2090
        • Summa Center for Cancer Care at Akron City Hospital
      • Cincinnati, Ohio, Spojené státy, 45267
        • Charles M. Barrett Cancer Center at University Hospital
      • Salem, Ohio, Spojené státy, 44460
        • Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
      • West Chester, Ohio, Spojené státy, 45069
        • Precision Radiotherapy at University Pointe
      • Wooster, Ohio, Spojené státy, 44691
        • Cancer Treatment Center
    • Pennsylvania
      • Abington, Pennsylvania, Spojené státy, 19001
        • Rosenfeld Cancer Center at Abington Memorial Hospital
      • Bryn Mawr, Pennsylvania, Spojené státy, 19010
        • Bryn Mawr Hospital
      • Gettysburg, Pennsylvania, Spojené státy, 17325
        • Adams Cancer Center
      • Paoli, Pennsylvania, Spojené státy, 19301-1792
        • Cancer Center of Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, Spojené státy, 19111-2497
        • Fox Chase Cancer Center - Philadelphia
      • Wynnewood, Pennsylvania, Spojené státy, 19096
        • Lankenau Cancer Center at Lankenau Hospital
      • York, Pennsylvania, Spojené státy, 17405
        • York Cancer Center at Apple Hill Medical Center
    • Tennessee
      • Kingsport, Tennessee, Spojené státy, 37662
        • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
    • Utah
      • Murray, Utah, Spojené státy, 84157
        • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
      • Ogden, Utah, Spojené státy, 84403
        • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
      • Provo, Utah, Spojené státy, 84604
        • Utah Valley Regional Medical Center - Provo
      • Saint George, Utah, Spojené státy, 84770
        • Dixie Regional Medical Center - East Campus
      • Salt Lake City, Utah, Spojené státy, 84143
        • LDS Hospital
    • Vermont
      • Saint Johnsbury, Vermont, Spojené státy, 05819
        • Norris Cotton Cancer Center - North
    • Virginia
      • Norfolk, Virginia, Spojené státy, 23507
        • Sentara Cancer Institute at Sentara Norfolk General Hospital
      • Portsmouth, Virginia, Spojené státy, 23708-2197
        • Naval Medical Center - Portsmouth
    • Washington
      • Yakima, Washington, Spojené státy, 98902
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
    • Wisconsin
      • Appleton, Wisconsin, Spojené státy, 54911
        • Theda Care Cancer Institute
      • Green Bay, Wisconsin, Spojené státy, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Marinette, Wisconsin, Spojené státy, 54143
        • Bay Area Cancer Care Center at Bay Area Medical Center
      • Menomonee Falls, Wisconsin, Spojené státy, 53051
        • Community Memorial Hospital Cancer Care Center
      • Milwaukee, Wisconsin, Spojené státy, 53226
        • Medical College of Wisconsin Cancer Center
      • Milwaukee, Wisconsin, Spojené státy, 53295
        • Veterans Affairs Medical Center - Milwaukee
      • Milwaukee, Wisconsin, Spojené státy, 53215
        • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
      • West Allis, Wisconsin, Spojené státy, 53227
        • West Allis Memorial Hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Mužský

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Doplněk stravy: Calcium
A single dose of 500 mg of elemental calcium orally each day for 3 years.
Doplněk stravy: Zoledronic acid
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.
Ostatní jména:
  • Zometa
  • zoledronát
Záření: radiation therapy
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.
Lék: LHRH
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.
Doplněk stravy: Vitamin D
400 IU (10μg), orally each day for 3 years.
Aktivní komparátor: Control
Vitamin D and calcium supplement everyday for 3 years in addition to concurrent radiation therapy and LHRH therapy.
Doplněk stravy: Calcium
A single dose of 500 mg of elemental calcium orally each day for 3 years.
Záření: radiation therapy
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.
Lék: LHRH
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.
Doplněk stravy: Vitamin D
400 IU (10μg), orally each day for 3 years.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Freedom From Any Bone Fracture (FABF) Rate at Three Years
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percent Change in Bone Mineral Density at 3 Years
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Radiation Therapy Oncology Group

Spolupracovníci

National Cancer Institute (NCI)

Vyšetřovatelé

  • Vrchní vyšetřovatel: Colleen A. Lawton, MD, Medical College of Wisconsin
  • Studijní židle: Matthew R. Smith, MD, Massachusetts General Hospital
  • Studijní židle: Margaret Chamberlain-Wilmoth, PhD, MSS, RN, Carolinas Medical Center - University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. března 2006

Primární dokončení (Aktuální)

1. listopadu 2014

Dokončení studie (Aktuální)

1. listopadu 2014

Termíny zápisu do studia

První předloženo

23. května 2006

První předloženo, které splnilo kritéria kontroly kvality

23. května 2006

První zveřejněno (Odhad)

25. května 2006

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

29. listopadu 2017

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

23. října 2017

Naposledy ověřeno

1. října 2017

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • RTOG 0518
  • CDR0000476469
  • NCI-2009-00884 (Identifikátor registru: CTRP (Clinical Trial Reporting Program))

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Podmínky

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