A Study to Evaluate New or Worsening Lens Opacifications in Subjects With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss Due to Androgen-Deprivation Therapy

Prostate Cancer Clinical Trial

Official title:

A Double-blind, Placebo-controlled Study to Evaluate New or Worsening Lens Opacifications in Subjects With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss Due to Androgen-Deprivation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00925600
• Other study ID #: 20080560
• Status: Completed
• Phase: Phase 3
• First received: June 18, 2009
• Last updated: June 27, 2016
• Start date: November 2009
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Statni ustav pro kontrolu lecivEU: CHMPEuorpean Union: Ethics CommitteeEuropean Union: European Medicines AgencyFrance and Sweden: European Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: CCPPRB Central Ethics CommitteeFrance: CCTIRS: Advisory Committee on Medical research Data ProcessingAustralia: Cabrini Human Research Ethics CommitteeAustralia: Cancer Institute NSW Clinical ResearchAustralia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: Eastern Health Research and Ethics CommitteeAustralia: HREC Ballarat Health ServicesAustralia: Human Research Ethics CommitteeAustralia: Mater Health Service Human Research Ethics CommitteeFrance: Central EC, called Comite de Protection des PersonnesFrance: CNIL: National Computers and Privacy CommissionFrance: Ministry of HealthFrance:CNOM: National Council of the French Medical AssociationGreece: National Ethics CommitteeGreece: National Organization for MedicinesHungary: Central Ethics CommitteeHungary: National Institute of PharmacyAustralia: Royal Adelaide Hospital Research Ethics CommitteeAustralia: Therapeutic Goods AdministrationBulgaria: Bulgarian Drug AgencyBulgaria: Ministry of HealthCanada: Health CanadaCanada: Health Products and Food BranchCanada: Institutional Review BoardCzech Republic: State Institute for Drug ControlLatvia: State Agency of MedicinesMexico: COFEPRISMexico: Ministry of HealthMexico: SSA (Secretaria de Salud Publica)Poland: Drug InstitutPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ministry of HealthSlovakia: Ministry of HealthSlovakia: State Institiute for Drug ControlRussia: Federal Service for Surveillance in the field of Healthcare and Social Development (a body of the Ministry of Health)Slovenia: Agency for Medicinal Products and Medicinal Devices of the Republic of Slovenia (ARSZMP)Slovenia: National Medical Ethics Committee (Komisija Republike Slovenije Za Medicinsko Etiko)South Africa: Department of HealthUnited States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited States: IntegReview Ethical Review BoardUnited States: MD Anderson Surveillance Committee FWA-363United States: Quorom Institutional Review BoardUnited States: Western Institutional Review BoardSlovakia: Štátny ústav pre kontrolu liecivUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate new or worsening lens opacifications in subjects with non-metastatic prostate cancer receiving denosumab for bone loss due to androgen deprivation therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 760
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 120 Years

Eligibility

Inclusion Criteria:

• Men = 30 years of age with non-metastatic prostate cancer, having undergone bilateral orchiectomy or initiated ADT with GnRH agonists and is expected to continue on ADT for at least 12 months

• Adequate visual accuracy allowing eye testing

• Bone Mineral Density (BMD) requirements: Osteopenia if under 70 years of age; Osteopenia or normal BMD if over 70 years of age

• Signed informed consent

Exclusion Criteria:

• Previous surgery for cataracts in both eyes, current diagnosis of cataracts, cataracts surgery foreseen in the near future, or ocular disease leading to visual loss

• Diagnosis of osteoporosis

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer
• Cataract
• Low Bone Mineral Density
• Osteopenia
• Osteoporosis
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• Denosumab
Denosumab 60 mg is administered subcutaneously on Day 1 and Month 6.
• Placebo
Placebo administered subcutaneously on Day 1 and Month 6.

Locations

Country	Name	City	State
Australia	Research Site	Bentleigh East	Victoria
Australia	Research Site	Herston	Queensland
Australia	Research Site	Ringwood East	Victoria
Australia	Research Site	Wahroonga	New South Wales
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Sofia
Canada	Research Site	Barrie	Ontario
Canada	Research Site	Brampton	Ontario
Canada	Research Site	Brantford	Ontario
Canada	Research Site	Burlington	Ontario
Canada	Research Site	Guelph	Ontario
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Kelowna	British Columbia
Canada	Research Site	Kitchener	Ontario
Canada	Research Site	Laval	Quebec
Canada	Research Site	London	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Newmarket	Ontario
Canada	Research Site	North Bay	Ontario
Canada	Research Site	North York	Ontario
Canada	Research Site	Oakville	Ontario
Canada	Research Site	Scarborough	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia
Canada	Research Site	Victoria	British Columbia
Canada	Research Site	Victoria	British Columbia
Czech Republic	Research Site	Benesov
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Hradec Kralove
Czech Republic	Research Site	Jindrichuv Hradec
Czech Republic	Research Site	Kromeriz
Czech Republic	Research Site	Novy Jicin
Czech Republic	Research Site	Olomouc
Czech Republic	Research Site	Plzen
Czech Republic	Research Site	Praha 2
Czech Republic	Research Site	Praha 4
Czech Republic	Research Site	Praha 6
Czech Republic	Research Site	Usti nad Labem
Czech Republic	Research Site	Zlin
France	Research Site	Lyon Cédex 3
France	Research Site	Paris Cedex 5
Greece	Research Site	Alexandroupoli
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Heraklion
Greece	Research Site	Larissa
Greece	Research Site	Patra
Greece	Research Site	Thessaloniki
Greece	Research Site	Thessaloniki
Hungary	Research Site	Baja
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Gyor
Hungary	Research Site	Miskolc
Hungary	Research Site	Nyiregyhaza
Hungary	Research Site	Szeged
India	Research Site	Ahmedabad	Gujarat
India	Research Site	Aurangabad	Maharashtra
India	Research Site	Bangalore	Karnataka
India	Research Site	Kolkata	West Bengal
India	Research Site	Ludhiana	Punjab
India	Research Site	Madurai	Tamil Nadu
India	Research Site	Nashik	Maharashtra
Latvia	Research Site	Jelgava
Latvia	Research Site	Riga
Latvia	Research Site	Riga
Mexico	Research Site	Distrito Federal
Mexico	Research Site	Distrito Federal
New Zealand	Research Site	Christchurch
New Zealand	Research Site	Takapuna, North Shore City
New Zealand	Research Site	Tauranga
New Zealand	Research Site	Whangarei
Poland	Research Site	Gdansk
Poland	Research Site	Gdansk
Poland	Research Site	Gdynia
Poland	Research Site	Gdynia
Poland	Research Site	Katowice
Poland	Research Site	Myslowice
Poland	Research Site	Opole
Poland	Research Site	Poznan
Poland	Research Site	Rzeszow
Poland	Research Site	Siedlce
Poland	Research Site	Slupsk
Poland	Research Site	Szczecin
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Wroclaw
Russian Federation	Research Site	Ivanovo
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Nizhny Novgorod
Russian Federation	Research Site	Rostov-na-Donu
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Kosice
Slovakia	Research Site	Kosice
Slovakia	Research Site	Kosice
Slovakia	Research Site	Martin
Slovakia	Research Site	Nitra
Slovakia	Research Site	Trencin
Slovenia	Research Site	Celje
Slovenia	Research Site	Ljubljana
Slovenia	Research Site	Slovenj Gradec
South Africa	Research Site	George
South Africa	Research Site	Kempton Park
South Africa	Research Site	Paarl	Western Cape
South Africa	Research Site	Port Elizabeth
South Africa	Research Site	Tygerberg
Ukraine	Research Site	Chernivtsi
Ukraine	Research Site	Dnipropetrovsk
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Uzhgorod
Ukraine	Research Site	Zaporizhzhya
United States	Research Site	Albany	New York
United States	Research Site	Anaheim	California
United States	Research Site	Annapolis	Maryland
United States	Research Site	Austin	Texas
United States	Research Site	Bala Cynwyd	Pennsylvania
United States	Research Site	Baltimore	Maryland
United States	Research Site	Berlin	New Jersey
United States	Research Site	Brick	New Jersey
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Coeur d'Alene	Idaho
United States	Research Site	Dallas	Texas
United States	Research Site	Denver	Colorado
United States	Research Site	Denver	Colorado
United States	Research Site	Englewood	Colorado
United States	Research Site	Englewood	New Jersey
United States	Research Site	Garden City	New York
United States	Research Site	Gastonia	North Carolina
United States	Research Site	Grand Rapids	Michigan
United States	Research Site	Greenbelt	Maryland
United States	Research Site	Greenville	North Carolina
United States	Research Site	Greenwood	Indiana
United States	Research Site	Kansas City	Kansas
United States	Research Site	Kingston	New York
United States	Research Site	Knoxville	Tennessee
United States	Research Site	Laguna Hills	California
United States	Research Site	Lancaster	Pennsylvania
United States	Research Site	Lawrenceville	New Jersey
United States	Research Site	Middlebury	Connecticut
United States	Research Site	Missoula	Montana
United States	Research Site	Mount Laurel	New Jersey
United States	Research Site	Murrieta	California
United States	Research Site	Myrtle Beach	South Carolina
United States	Research Site	New Britain	Connecticut
United States	Research Site	New York	New York
United States	Research Site	Omaha	Nebraska
United States	Research Site	Omaha	Nebraska
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Poughkeepsie	New York
United States	Research Site	Richmond	Virginia
United States	Research Site	Salem	Virginia
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	San Diego	California
United States	Research Site	San Diego	California
United States	Research Site	San Luis Obispo	California
United States	Research Site	Sartell	Minnesota
United States	Research Site	Shreveport	Louisiana
United States	Research Site	St Louis	Missouri
United States	Research Site	Syracuse	New York
United States	Research Site	Temple	Texas
United States	Research Site	Trinity	Florida
United States	Research Site	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Canada,  Czech Republic,  France,  Greece,  Hungary,  India,  Latvia,  Mexico,  New Zealand,  Poland,  Russian Federation,  Slovakia,  Slovenia,  South Africa,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subject incidence of lens opacification event development or progression by month 12, based on a change of = 1.5 in P, = 1.5 in C, or = 1.5 in NO in the LOCS III score.	Lens opacification event development or progression	one year	Yes
Other	Subject incidence of lens opacification event development or progression by month 6, based on a change of = 1.0 in P, = 1.0 in C, or = 0.7 in NO in the LOCS III score.	Lens opacification event development or progression.	6 months	Yes
Other	Subject incidence of a decrease from baseline BCVA as measured by a change of = 10 letters on the ETDRS at 4 meters, at months, 3, 6, 9, and 12.	Incidence of decreased best corrected visual acuity (BCVA)	one year	Yes
Other	Change in refraction needed to achieve BCVA at 3, 6, 9, and 12 as measured by change in sphere	Change in refraction needed to achieve BCVA	one year	Yes
Other	Adverse event incidence, serious adverse event incidence, changes in safety laboratory analytes (ie, serum chemistry).	Safety as measured by adverse events and safety laboratory parameters	one year	Yes
Other	Subject incidence of confirmed lens opacification event development or progression by month 12, based on a change of =1.0 in P, =1.0 in C, or =0.7 in NO in the LOCSIII score.	Confirmed lens opacification event development or progression. A confirmed lens opacification event development or progression is defined as 2 directly subsequent events per protocol assessments at the same location (P,C,NO) using LOCIII as above.	one year	Yes
Primary	Subject incidence of lens opacification event development or progression by month 12, based on a change of = 1.0 in P, = 1.0 in C, or = 0.7 in NO in the LOCS III score.	Lens opacification event development or progression	one year	Yes

External Links

•   AmgenTrials clinical trials website