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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. oktober 2017 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

109

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Kosttilskudd: Calcium
A single dose of 500 mg of elemental calcium orally each day for 3 years.
Kosttilskudd: 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.
Andre navn:
  • Zometa
  • zoledronat
Stråling: 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.
Legemiddel: 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.
Kosttilskudd: Vitamin D
400 IU (10μg), orally each day for 3 years.
Aktiv komparator: Control
Vitamin D and calcium supplement everyday for 3 years in addition to concurrent radiation therapy and LHRH therapy.
Kosttilskudd: Calcium
A single dose of 500 mg of elemental calcium orally each day for 3 years.
Stråling: 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.
Legemiddel: 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.
Kosttilskudd: Vitamin D
400 IU (10μg), orally each day for 3 years.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Freedom From Any Bone Fracture (FABF) Rate at Three Years
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percent Change in Bone Mineral Density at 3 Years
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Radiation Therapy Oncology Group

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2006

Primær fullføring (Faktiske)

1. november 2014

Studiet fullført (Faktiske)

1. november 2014

Datoer for studieregistrering

Først innsendt

23. mai 2006

Først innsendt som oppfylte QC-kriteriene

23. mai 2006

Først lagt ut (Anslag)

25. mai 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. november 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. oktober 2017

Sist bekreftet

1. oktober 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere