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Prostate CancerPhase 2NCT00459654

A Placebo-controlled Phase II Study of Bone-targeted Radium-223 in Symptomatic Hormone-refractory Prostate Cancer

A Phase 2 study testing Radium-223 dichloride (BAY88-8223) and Saline in people with Prostate Cancer and Neoplasm Metastasis, run by Bayer at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 40 years and older, men only
Conditions the study is for
Prostate Cancer, Neoplasm Metastasis
What is being tested?
Radium-223 dichloride (BAY88-8223) and Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
3 sitesin 2 countries
Study dates
Feb 2004to May 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically/cytologically confirmed adenocarcinoma of the prostate
  • Patient has received or is receiving hormonal treatment (orchiectomy, polyoestradiol phosphate, or gonadotropin-releasing hormone analogue with or without antiandrogen)
  • Metastatic disease with positive bone scan within 2 months before treatment with more than one cancer related lesion or with one painful cancer related lesion in the presence of increasing PSA levels as follows: PSA >5 ng/ml, with increases on at least 2 successive occasions at least 2 weeks apart.
  • Patient is referred to local field radiotherapy (EBR) for metastatic bone pain. The area to be treated (index site) should match the positive bone scan, local radiation area not exceeding 400 cm2
  • ECOG performance status: 0-2
  • Life expectancy: at least 3 months
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  • Age more than 40 years
  • Laboratory requirements:
  • Hematology: Neutrophil count ≥1,5 x 109/L Platelet count at least ≥100 x109/L and stable Hemoglobin >100 g/l or 10 g/dL
  • Hepatic function: Bilirubin within normal institutional limits ASAT and ALAT <2,5 times upper limit of normal (ULN)
  • Renal function: Creatinine <1,5 times the ULN (i.e. NCI grade ≤1)
  • Patient is willing and able to comply with the protocol, and agrees to return to the hospital for follow-up visits and examinations
  • Patient has been fully informed about the study and has signed the informed consent form

Who cannot join

  • Has received an investigational drug in the 4 weeks before or is scheduled to receiving one during the planned treatment period
  • Has received chemo-, immunotherapy or external radiotherapy within weeks before study drug administration
  • Has started treatment with bisphosphonates within 3 months before administration of study drug.
  • Has previously received systemic radiotherapy with strontium, samarium or rhenium
  • Change in hormonal therapy within the last 6 weeks before study drug administration
  • Other currently active (relapse within the last 3 year) malignancy (except nonmelanoma skin cancer) or known brain, liver, lung, visceral and lymphatic metastases dominating the clinical picture of the patient
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  • Has received blood transfusion within last month
  • Other serious illness or medical condition as follows:
  • any uncontrolled infection
  • heart insufficiency, grade 3 or 4 as specified in NCI-CTC criteria
  • grade 2 or greater motor or sensory neuropathy
  • Crohn's disease or Ulcerative colitis 9) Known non-pathological bone fracture within the last two months

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Sweden2 sites

  • Study site

    Linköping

  • Study site

    Sundsvall

Other trials in Sweden

United Kingdom1 site

  • Study site

    Nottingham

Other trials in United Kingdom

About this study

Official title: A Phase II Randomised, Placebo-controlled, Multicentre Study in Prostate Cancer Patients With Painful Bone Metastases to Evaluate the Efficacy of Repeated Radium-223 Injections

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

Read the detailed description

Primary objective:

To study the biological effectiveness of radium-223 therapy measured as:

  • Time to occurrence of skeletal-related events(SREs)
  • Change in bone-specific alkaline phosphatase (bone-ALP) levels

Secondary objectives:

To study the efficacy of radium-223 therapy in terms of:

  • Frequency of new SREs
  • Proportions of patients with an SRE
  • Proportions of patients with SRE at different time points
  • Changes of biochemical markers of bone turnover
  • Treatment response with regard to pain and analgesic use(termed "Palliative effect" in study protocol)
  • Quality of life assessment
  • Overall survival To study the safety of the repeated radium-223 regimen Total Enrollment:64 Study start: February 2004
Being tested
Radium-223 dichloride (BAY88-8223), Saline
Keywords
HRPC, Recurrent Prostate Cancer, Metastatic Cancer
Medical subject headings
Prostatic Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radium-223 dichloride (BAY88-8223)Drug

    Four Radium-223 injections were given at 4-weekly intervals starting after the first fraction of EBR.

  • SalineDrug

    Four Saline injections were given at 4-weekly intervals starting after the first fraction of EBR.

Study groups in NCT00459654
Study groupRoleWhat they receive
Radium-223 dichloride (Xofigo, BAY88-8223)ExperimentalEach subject receives local filed external beam radiotherapy (EBR) and repeated injections of the investigational drug radium-223 (EBR+Radium-223)
Receives: Drug: Radium-223 dichloride (BAY88-8223)
SalinePlacebo comparatorEach subject receives local filed external beam radiotherapy (EBR) and repeated injections of saline (EBR+placebo)
Receives: Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to occurrence of Skeletal-related Events (SRE)

    SREs are defined as: Increase in pain severity index during the last week; Increase in analgesic consumption; Neurological symptoms secondary to skeletal manifestations of prostate cancer; New pathologic bone fractures (vertebral and non-vertebral); Tumour related orthopaedic surgical intervention; Subsequent external beam radiation to relieve skeletal pain; Use of radioisotopes to relieve new skeletal related symptoms; Use of corticosteroids for skeletal pain, at doses aimed for pain palliation; Use of chemotherapy, bisphosphonates, or hormones, for the treatment of skeletal disease progression

    Measured: Up to 12 Month

  2. Relative change (%) in bone-ALP levels from baseline to 4 weeks after last injection

    Measured: Up to 12 Month

Secondary outcomes (9)

  1. Number of SREs per patient

    Measured: Up to 12 Month

  2. Changes in the levels of biochemical markers of bone formation

    Measured: Up to 12 Month

  3. Change in Prostate Specific Antigen (PSA)

    Measured: Up to 12 Month

  4. Change in pain level

    Measured: Up to 12 Month

  5. Changes in analgesic use during study period

    Measured: Up to 12 Month

  6. Changes in Edmonton Symptom Assessment Scale (ESAS) from baseline

    Measured: Up to 12 Month

  7. Overall survival

    Measured: up to 24 months

  8. Adverse events

    Measured: up to 24 months

  9. Clinical laboratory tests including haematology, renal and liver function parameters

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2007 (estimated)
  2. Study startFeb 2004
  3. Primary completionMay 2006
  4. Study completionMay 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00459654
Sponsor's protocol ID
15280
Other IDs
BC1-02
Status last verified
Jun 2014
First submitted
11 Apr 2007
Last updated
25 Jun 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radium-223 dichloride (BAY88-8223) and Saline in people with Prostate Cancer and Neoplasm Metastasis, run by Bayer at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to occurrence of Skeletal-related Events (SRE) (time frame: Up to 12 Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00459654.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2014.

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