Alpharadin< span style="font-size: 18pt; fo…" /> Fase III studie voor patiënten met hormoonrefractaire botmetastasen | Prostaatkanker

Fase III studie voor patiënten met hormoonrefractaire botmetastasen

A Phase III Study of Alpharadin (Radium-223) in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases (ALSYMPCA)

This study is currently recruiting participants.

Sponsored by:

Algeta ASA

Information provided by:

Algeta ASA

http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif  Purpose

ALSYMPCA is an international Phase III clinical study to evaluate the efficacy and safety of Alpharadin, in patients with hormone refractory prostate cancer and skeletal metastases.



Condition

Intervention

Phase

Hormone Refractory Prostate Cancer
Bone Metastases

Drug: Alpharadin (Radium-223)
Drug: Placebo

Phase III

 

Study Type:

Interventional

Study Design:

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:

A Double-Blind, Randomised, Multiple Dose, Phase III, Multicentre Study of Alpharadin in the Treatment of Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases

 

 

Further study details as provided by Algeta ASA:

 

Primary Outcome Measures:

·         Overall survival [ Time Frame: Time from date of randomisation to the date of event ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

·         Time to occurrence of specific disease events [ Time Frame: Time to first on-study specific disease events ] [ Designated as safety issue: Yes ]

·         Changes and time to progression in PSA [ Time Frame: Study duration ] [ Designated as safety issue: No ]

·         Changes and time to progression in total-ALP [ Time Frame: Study duration ] [ Designated as safety issue: No ]

·         Safety endpoints; Adverse events, laboratory values, potential manifestations of late toxicity [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]

·         Clinical benefit endpoints: Performance status, Health related Quality of Life [ Time Frame: Study duration ] [ Designated as safety issue: No ]

 

Estimated Enrollment:

900

Study Start Date:

June 2008

Estimated Study Close Date:

December 2010

 

Arms

Assigned Interventions

1: Experimental

Alpharadin plus best standard of care

Drug: Alpharadin (Radium-223)

Alpharadin (Radium-223) 50 kBq/kg b.w., 6 IV administrations separated by 4 weeks intervals

2: Placebo Comparator

Saline solution plus best standard of care

Drug: Placebo

Isotonic saline 6 IV administrations separated by 4 weeks intervals


Detailed Description:

The aim of the study is to compare, in patients with symptomatic HRPC and skeletal metastases, the efficacy of best standard of care plus Alpharadin versus best standard of care plus placebo, with the primary efficacy endpoint being overall survival (OS).

Patients will be randomised in a 2:1 allocation ratio (Alpharadin:Placebo). The study treatment consists of 6 intravenous administrations of Alpharadin or placebo (saline) each separated by an interval of 4 weeks. The patient will be followed until 3 years after first study drug administration.

http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif  Eligibility

Ages Eligible for Study:  

18 Years and older

Genders Eligible for Study:  

Male

Accepts Healthy Volunteers:  

No

Criteria

Main inclusion criteria:

·         Histologically or cytologically confirmed adenocarcinoma of the prostate

·         Known hormone refractory disease

·         Multiple skeletal metastases (≥ 2 hot spots) on bone scintigraphy

·         No intention to use cytotoxic chemotherapy within the next 6 months

·         Either regular (not occasional) analgesic medication use for cancer related bone pain or treatment with EBRT for bone pain

Main exclusion criteria:

·         Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period

·         Eligible for first course of docetaxel, i.e. patients who are fit enough, willing and where docetaxel is available.

·         Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks ago

·         Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks

·         Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)

·         History of visceral metastasis, or visceral metastases as assessed by abdominal/pelvic CT or chest x-ray within previous 8 weeks

http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif  Contacts and Locations

Contacts

Contact: Bjørg Bolstad

+47 23 00 79 90

bjorg.bolstad@algeta.com

Contact: Ingvild Haugen

+47 23 00 79 90

ingvild.haugen@algeta.com


Sponsors and Collaborators

Algeta ASA

Investigators

Study Chair:

Christopher Parker, M.D.

The Royal Marsden Hospital, UK

http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif  More Information

 

Responsible Party:

Algeta ASA, Oslo, Norway

Study ID Numbers:

BC1-06

   
   
   
   

For your information, we are suggesting that patients who wish to be considered for inclusion in the ALSYMPCA trial, should either:

a)      ask their GP to contact the hospital closest to them, which is involved in the trial to discuss their suitability for this trial. Patients should please go to www.algeta.com to see a list of the hospitals.. Should their GP need further information on the study, the following can be contacted : Bjorg Bolstad or Gillies O’Bryan-Tear at Algeta (+47 23 00 79 90) or by emailing alpharadin@algeta.com).

or:

b)      ask their oncologist to contact the hospital closest to them, which is involved in the trial.

 

There are now 3 centres participating in the study in the Netherlands and these are, for your information :

 

Dr. Verhagen

Erasmus Medish Centrum, Rotterdam

Dr. Vergunst

Canisius-Wilhelmina Ziekenhuis, Nijmegen

Dr. Roeleveld

Medical centre, Alkmaar

   

---