A Dose Finding Study of Radium-223 for Prostate Cancer Patients With Bone Metastases

This study has been completed.
Sponsor:
Information provided by:
Algeta ASA
ClinicalTrials.gov Identifier:
NCT00337155
First received: June 13, 2006
Last updated: September 8, 2010
Last verified: September 2010
  Purpose

The purpose of this study is to evaluate the effectiveness of the investigational radioisotope Radium-223, Alpharadin, in treatment of men with prostate cancer and bone metastases that no longer respond to hormonal treatment


Condition Intervention Phase
Prostate Cancer
Neoplasm Metastasis
Drug: Radium-223 (Alpharadin )
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomised, Dose Finding, Repeat Dose, Phase II, Multicentre Study of AlpharadinTM for the Treatment of Patients With Hormone Refractory Prostate Cancer and Skeletal Metastases.

Resource links provided by NLM:


Further study details as provided by Algeta ASA:

Primary Outcome Measures:
  • PSA response; each patient will be classified as PSA responder/non-responder according to the definition of PSA response:a decrease from baseline of at least 50% maintained for at least three weeks. [ Time Frame: 24 weeks, 12 months, 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The maximum percent decrease in PSA level compared to baseline [ Time Frame: 24 weeks, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Time to PSA Progression [ Time Frame: 24 weeks, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Bone-ALP response (classified as for PSA response) and decrease in bone-ALP level compared to baseline [ Time Frame: 24 weeks, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Time to Skeletal Related Events (SRE) [ Time Frame: 24 weeks, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Total number of SRE per patient [ Time Frame: 24 weeks, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Pain Assessment and analgesic consumption [ Time Frame: 24 weeks, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Adverse events, blood chemistry and haematological toxicity [ Time Frame: 24 weeks, 12 months, 24 months ] [ Designated as safety issue: Yes ]
  • Time to death from first treatment [ Time Frame: 24 weeks, 12 months, 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 117
Study Start Date: May 2006
Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Drug: Radium-223 (Alpharadin )
3 doses of Alpharadin (radium-223) at different dose levels, 25, 50 or 80 kBq/kg b.w.given as injection.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically or cytologically confirmed adenocarcinoma of the prostate.
  2. Hormone refractory with evidence of rising PSA:

    • Patient must be maintained on androgen ablation therapy with LHRH agonist (stable dose for at least 8 weeks prior to study entry), or have undergone orchiectomy
    • Serum testosterone level is required to be ≤ 50 ng/dl
    • Patients who have received prior hormonal drug therapy:

      • Flutamide, nilutamide or cyproterone acetate must have stopped at least four weeks prior to study drug administration and progression must have been demonstrated since cessation;
      • Bicalutamide must have stopped at least six weeks prior to study drug administration and progression must have been demonstrated since cessation
    • Elevated and rising PSA:

      • Baseline PSA level ≥ 10 ng/ml
      • Progressive rise in PSA, defined as two consecutive increases in PSA documented over a previous reference value (measure 1). The first increase in PSA (measure 2) should occur a minimum of 1 week from the reference value (measure 1. This increase in PSA should be confirmed (measure 3) after a minimum of 1 week. If the confirmatory PSA value (measure 3) is less than the previous value, the patient will still be eligible provided the next PSA measure (measure 4)is found to be greater than the second PSA value(measure 2).
  3. Multifocal skeletal metastases confirmed by bone scintigraphy within the last 6 weeks
  4. Performance status: ECOG 0-2
  5. Life expectancy: At least 6 months
  6. Laboratory requirements:

    • Neutrophil count ≥ 1.5 x 109/L
    • Platelet count ≥ 100 x109/L
    • Haemoglobin ≥ 95 g/L
    • Total bilirubin level within normal institutional limits
    • ASAT and ALAT ≤ 2,5 times upper institutional limit of the normal range
  7. The patient is willing and able to comply with the protocol (including maintenance of patient diary), and agrees to return to the hospital for follow-up visits and examination
  8. The patient has been fully informed about the study and has signed the informed consent form

Exclusion Criteria:

  1. Has received an investigational drug within 4 weeks prior to the administration of radium-223, or is scheduled to receive one during the treatment and post-treatment period
  2. Has received chemo-, immunotherapy, or external radiotherapy within the last 4 weeks prior to administration of study drug, or has not recovered from adverse events due to agents administered more than 4 weeks earlier
  3. More than one regimen of previous cytotoxic chemotherapy
  4. Has received prior hemibody external radiotherapy
  5. Has a need for immediate external radiotherapy
  6. Has received systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within the last year prior to administration of study drug
  7. Has started treatment with bisphosphonates less than 3 months prior to administration of study drug. Patients are allowed to be on bisphosphonates provided patient is on a stable dose for ≥ 12 weeks before administration of study drug.
  8. Patients who are ≤ 4 weeks (6 weeks for bicalutamide) post withdrawal of antiandrogen therapy
  9. Patients who have started or stopped systemic steroids, within a week prior to study drug administration
  10. Other currently active (relapse within the last 3 years) malignancy (except non-melanoma skin cancer) that are not prostate cancer metastases
  11. Visceral metastases from prostate cancer as assessed by abdominal/pelvic CT or MRI within six weeks before administration of study drug; Lung lesions from prostate cancer as assessed by chest Xray within 6 weeks. This requirement does not include abdominal or pelvic lymph node involvement (individual lymph node size must not exceed 1 cm in short diameter) which is acceptable
  12. Bulky loco-regional disease
  13. Any other serious illness or medical condition, for example:

    • any uncontrolled infection
    • any patient who has clinical heart failure severe enough to cause marked limitation of activity, and who is only comfortable at rest; or any patient who has heart failure more severe than this (NYHA Heart Failure Class III or IV
    • Crohns disease or ulcerative colitis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00337155

Locations
United Kingdom
The Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5RT
Sponsors and Collaborators
Algeta ASA
Investigators
Principal Investigator: Chrisopher Parker, MD The Royal Marsden Hospital, Sutton, UK
Principal Investigator: O'Sullivan Joe, MD Belfast City Hospital, Lisburn Road, Belfast BT9 7AB, UK
Principal Investigator: Hoskin Peter, MD Mount Vernon Hospital, Cancer Centre, Northwood, Midddelsex, HA6 2RN, UK
Principal Investigator: Tyrrell Christopher, MD Plymouth Oncology Centre, Derriford Hospital, Plymouth, PL6 8DH, UK
Principal Investigator: Bottomly David, MD Cookridge Hospital, Hospital Lane, leeds LS16 6QB, UK
Principal Investigator: Mellado Begona, MD Hospital Clinic, c/Villarroel, 170, Barcelona, Spain
Principal Investigator: Maroto Pablo, MD Hospital St Pau, Medical Oncology, Av. Sant Antoni M. Claret, 167, Barcelona, Spain
Principal Investigator: Andres Redondo, MD Hospital La Paz, Paseo de la Castellana, 261 Madrid, Spain
Principal Investigator: Josep Ramon Germà, MD Institut Català d'Oncologia (ICO), Barcelona, Spain
Principal Investigator: Bozena Birkenfeld, MD Medical University,1 Uni Lubelskiej Str., 71-242 Szczecin, Poland
Principal Investigator: Andrzej Kolodziejczyk, MD Military Hospital, 5 Weigla Street, Wroclaw, Poland
Principal Investigator: Barbara Jarzab, MD 15 Wybrzeze Armii Krajowej Street 44-101,Gliwice, Poland
Principal Investigator: Izabella Kozlowicz-Gudzińska, MD National Medical Institute of Oncology (M. Skłodowska-Curie), 5 Roentgena Str 02-781, Warschau, Poland
Principal Investigator: Leszek Krolicki, MD Medical Academy,University of Warschau, 1A Banacha Str 02-507 Warschau, Poland
Principal Investigator: Jerzy Sowiński, MD Hospital of Medical Academy, 49 Przybyszewskiego Str, Poznań. Poland
Principal Investigator: Piotr Lass, MD Institute of Radiology and Nuclear Medicine, 7 Debrinki Str., 80-211 Gdańsk, Poland
Principal Investigator: Ladislav Jarolim, MD University Hospital Motol, V uvalu 84,Prague 5, 150 06, Czech Republic
Principal Investigator: David Felts, MD, PhD University Hospital Ostrava, 17.listopadu 1790, Ostrava-Porub 708 52, Czech Republic
Principal Investigator: Ivan Pavlik, MD General University Hospital, Ke Karlovu 6, Praha2 128 08, Czech Republic
Principal Investigator: Milan Hora, MD University Hospital Plzen, E. Benese 13, Plzen 305 99, Czech Republic
Principal Investigator: Frantisek Zatura, MD University Hospital Olomouc, I.P. Pavlova 6, Olomouc 775 20, Czech Republic
Principal Investigator: Ales Chodacki, MD Hospital Chomutov, Kochova 1185, Chimutov 420 00, Czeck Republic
Principal Investigator: Ivo Kocak, MD Masaryk Memorial Cancer Institute, Žlutý kopec 7, Brno 656 53, Czech Republic
Principal Investigator: Miroslav Krhovsky, MD Hospital Kyjov, Urological Department, Strazovska 976, 697 33 Kyjov, Czech Republic
Principal Investigator: Isabelle Resche, MD René Gauducheau, Nantes, France, Boulevard Jacques Monod, 44805 Saint-Herblain, NANTES cedex
Principal Investigator: Pierre Olivier, MD CHU Nancy, Nancy, France, Médecine nucléaire - Avenue de Bourgogne, 54011 VANDOEUVRE LES NANCY
Principal Investigator: Pecking, MD Centre René Huguenin, France, 35 Rue Dailly, 92210 SAINT-CLOUD
Principal Investigator: Vuillez, MD CHU Michallon, Grenoble, France , Inserm 00-08, Service biophysique et médecine nucléaire, 38043 GRENOBLE Cedex
Principal Investigator: Mundler, MD Hôpital de la Timone, Marseille, France, Médecine Nucléaire, 264 Rue Saint-Pierre, 13385 MARSEILLE cedex 05
  More Information

No publications provided by Algeta ASA

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Ramdahl, President and Chief Executive Officer, Algeta ASA
ClinicalTrials.gov Identifier: NCT00337155     History of Changes
Other Study ID Numbers: BC1-04 EudraCTno2005-003680-22
Study First Received: June 13, 2006
Last Updated: September 8, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Spanish Agency of Medicines
Czech Republic: State Institute for Drug Control
Poland: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Algeta ASA:
Recurrent Prostate Cancer
metastatic Cancer

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Prostatic Neoplasms
Neoplastic Processes
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014