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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 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

109

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Manlig

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Kosttillskott: Calcium
A single dose of 500 mg of elemental calcium orally each day for 3 years.
Kosttillskott: 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.
Andra namn:
  • Zometa
  • zoledronat
Strålning: 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.
Läkemedel: 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.
Kosttillskott: 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.
Kosttillskott: Calcium
A single dose of 500 mg of elemental calcium orally each day for 3 years.
Strålning: 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.
Läkemedel: 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.
Kosttillskott: Vitamin D
400 IU (10μg), orally each day for 3 years.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Freedom From Any Bone Fracture (FABF) Rate at Three Years
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percent Change in Bone Mineral Density at 3 Years
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Radiation Therapy Oncology Group

Samarbetspartners

National Cancer Institute (NCI)

Utredare

  • Huvudutredare: 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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2006

Primärt slutförande (Faktisk)

1 november 2014

Avslutad studie (Faktisk)

1 november 2014

Studieregistreringsdatum

Först inskickad

23 maj 2006

Först inskickad som uppfyllde QC-kriterierna

23 maj 2006

Första postat (Uppskatta)

25 maj 2006

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 november 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 oktober 2017

Senast verifierad

1 oktober 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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