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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


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Hormone Refractory Prostate Cancer, Bone Metastases

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Trial Information

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


The aim of the study is to compare, in patients with symptomatic HRPC and skeletal
metastases, the efficacy of best standard of care plus Radium-223 dichloride 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 (Radium-223 dichloride:Placebo). The
study treatment consists of 6 intravenous administrations of Radium-223 dichloride or
placebo (saline) each separated by an interval of 4 weeks. The patient will be followed
until 3 years after first study drug administration.

Within the U.S., the trial is conducted under an IND sponsored by Bayer HealthCare
Pharmaceuticals.

All patients received BSoC (Best Standard of Care).


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 (External Beam Radiation Therapy) for bone pain

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

Time from date of randomisation to the date of event

Safety Issue:

Yes

Principal Investigator

Christopher Parker, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

The Royal Marsden Hospital, UK

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

15245

NCT ID:

NCT00699751

Start Date:

June 2008

Completion Date:

December 2013

Related Keywords:

  • Hormone Refractory Prostate Cancer
  • Bone Metastases
  • Hormone Refractory Prostate Cancer
  • Bone Metastases
  • Radium-223
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Prostatic Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases

Name

Location

Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Philadelphia, Pennsylvania  19104
Metairie, Louisiana  70006
Las Vegas, Nevada  89109