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Hormone Refractory Prostate CancerPhase 2NCT00667199

BAY88-8223, Does Response Study in HRPC Patients

A Phase 2 study testing Radium-223 dichloride (BAY88-8223) in people with Hormone Refractory Prostate Cancer and Bone Metastases, run by Bayer.

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 efficacy and safety of the investigational radioisotope Radium-223, Xofigo (Alpharadin), 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
What is being tested?
Radium-223 dichloride (BAY88-8223)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
30 May 2005to 6 Oct 2009
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 is hormone refractory with evidence of progressive disease:
  • Patient must be maintained on androgen ablation therapy with LHRH agonist or have undergone orchiectomy
  • Patient's testosterone level is required to be equal to or below 50 ng/dl
  • Patients in which flutamide, nilutamide, megestrol acetate, polyestradiol phosphate, aminoglutethimide, and ketoconazole, has been recently withdrawn must demonstrate progression of disease and be at last 4 weeks beyond the discontinuation of such agents; for bicalutamide 6 weeks is required
  • Increase in PSA levels in two consecutive measurements with at least one week apart, demonstrating an increase over the reference (nadir) value, and with the final PSA >/= 5 ng/ml
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  • A reference PSA (nadir) value must be measured at least 4 weeks after the discontinuation of flutamide, nilutamide, megestrol acetate, polyestradiol phosphate, aminoglutethimide, and ketoconazole, and at least 6 weeks after discontinuation of bicalutamide
  • If the third PSA value is lower than the second value, the patient could still be eligible, provided a fourth measurement obtained at least 1 week after the third PSA value, is grater than the second PSA value and >/= 5 ng/ml
  • Multifocal (>1) skeletal metastases confirmed by bone scintigraphy within 6 weeks
  • Bone pain with a score of at least 2 on BPI average pain, despite adequate use of analgesics, that correlates with areas of increased uptake (osteoblastic activity) on bone scintigraphy
  • Performance status: ECOG 0-2 or Karnofsky >/= 60%
  • Life expectancy: At least 3 months
  • Age more than 40 years
  • Laboratory requirements:
  • Neutrophil count >/= 1,5 x 109/L
  • Platelet count >/= 100 x109/L
  • Hemoglobin > 95 g/L
  • Bilirubin within normal institutional limits
  • ASAT and ALAT <2,5 times upper limit of normal (ULN)
  • The patient is willing and able to comply with the protocol (including maintenance of patient diary, completion of pain assessment forms), and agrees to return to the hospital for follow-up visits and examinations
  • The patient has been fully informed about the study and has signed the informed consent form

Who cannot join

  • Has received an investigational drug within 4 weeks before the administration of radium-223, or is scheduled to receiving one during the study period
  • Has received chemo-, immunotherapy, or external radiotherapy within the last 4 weeks prior to entering the study, or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Has received prior hemibody external radiotherapy
  • 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 inclusion
  • Has started treatment with bisphosphonates less than 3 months prior to administration of study drug
  • Patients experiencing hormone withdrawal syndrome, or are </= 4 weeks post withdrawal of antiandrogen therapy (6 weeks for bicalutamide)
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  • Patients who have started steroids or changed to treatment with steroids within the last 4 weeks prior to administration of radium-223
  • Has other clinically significant or symptomatic disease, which might interfere with the assessment of bone pain, e.g. spinal cord compression, compression or infiltration of a neural plexus, nerve root or peripheral nerves
  • Other currently active (relapse within the last 3 year) malignancy (except non-melanoma skin cancer), or known brain or visceral metastases dominating the clinical picture of the patient
  • Other serious illness or medical condition:
  • any uncontrolled infection
  • cardiac failure Classification III or IV (New York Heart Association)
  • Crohn disease or Ulcerative colitis
  • known bone fracture within 8 weeks

About this study

Official title: A Double Blind, Dose Response Phase II, Multicentre Study of Radium 223 (Alpharadin®) for the Palliation of Painful Bone Metastases in Hormone Refractory Prostate Cancer Patients

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

Read the detailed description

The study is designed to investigate whether there is a dose-response relationship for radium-223 in patients with painful bone metastases secondary to prostate carcinoma regarding palliation of bone pain. The palliative efficacy will be established through assessments of bone pain and consumption of analgesia. Furthermore, the aim is to find the most efficient dose with an acceptable safety profile. The safety will be assessed through measurements of adverse events, and acute haematological toxicity during the study period. Long-term chronic toxicity, and the overall survival at one and two years post treatment will also be assessed.

This is a double-blind, dose-response, randomized, multi-centre phase II efficacy and safety study of radium- 223. The clinical sites will enroll a total of 100 eligible patients. The treatment is a single intravenous administration of radium-223.

The target population is patients suffering from bone pain due to skeletal metastasis secondary to hormone refractory prostate cancer.

Being tested
Radium-223 dichloride (BAY88-8223)
Keywords
Hormone Refractory Prostate Cancer, Bone Metastases, Radium-223, Palliation of bone pain

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

    The required volume of study drug to be administered to a patient was calculated using the patient's body weight, the dose (5 , 25 , 50 or 100 kBq/kg b.w.)

Study groups in NCT00667199
Study groupRoleWhat they receive
Radium-223 dichloride (Xofigo, BAY88-8223)-5kBq/kgExperimentalEach patient received a single injection of radium-223 , based on the randomised dose level (5kBq/kg) and individual body weight. A second injection of radium-223 set to 50 kBq/kg b.w. could be offered to patients in the Follow-up Period at the discretion of the investigator.
Receives: Drug: Radium-223 dichloride (BAY88-8223)
Radium-223 dichloride (Xofigo, BAY88-8223)-25 kBq/kgExperimentalEach patient received a single injection of radium-223 , based on the randomised dose level (25kBq/kg) and individual body weight. A second injection of radium-223 set to 50 kBq/kg b.w. could be offered to patients in the Follow-up Period at the discretion of the investigator.
Receives: Drug: Radium-223 dichloride (BAY88-8223)
Radium-223 dichloride (Xofigo, BAY88-8223)-50 kBq/kgExperimentalEach patient received a single injection of radium-223 , based on the randomised dose level (50kBq/kg) and individual body weight. A second injection of radium-223 set to 50 kBq/kg b.w. could be offered to patients in the Follow-up Period at the discretion of the investigator.
Receives: Drug: Radium-223 dichloride (BAY88-8223)
Radium-223 dichloride (Xofigo, BAY88-8223)-100 kBq/kgExperimentalEach patient received a single injection of radium-223 , based on the randomised dose level (100kBq/kg) and individual body weight. A second injection of radium-223 set to 50 kBq/kg b.w. could be offered to patients in the Follow-up Period at the discretion of the investigator.
Receives: Drug: Radium-223 dichloride (BAY88-8223)

What is being measured

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

  1. Pain Assessment (using a 100mm Visual Analogue Scale)

    Measured: 16 weeks

  2. Analgesic consumption

    Measured: 16 weeks

Secondary outcomes (4)

  1. Reduction of pain: the pain dimension of Quality of Life assessed using the Brief Pain Inventory (BPI) form, with total pain score and subtotals, after injection and compared to scores at baseline

    Measured: 16 weeks

  2. Duration of pain relief: measured as the time between the first and last evaluation time points at which the pain response criteria were met

    Measured: 16 weeks

  3. The safety of radium-223: the total safety profile including adverse events and clinical laboratory measurements, with emphasis on haematological toxicity. Adverse events will be recorded continuously during the study period.

    Measured: 2 years

  4. The date of death (if within 24 months after the injection of study drug)

    Measured: 2 years

Timeline

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

  1. First posted28 Apr 2008 (estimated)
  2. Study start30 May 2005
  3. Primary completion1 Apr 2008
  4. Study completion6 Oct 2009

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
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00667199
Sponsor's protocol ID
15305
Other IDs
BC1-03, 2004-000299-15, 2004
Status last verified
Apr 2023
First submitted
24 Apr 2008
Last updated
19 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Nilsson S, Strang P, Aksnes AK, Franzen L, Olivier P, Pecking A, Staffurth J, Vasanthan S, Andersson C, Bruland OS. A randomized, dose-response, multicenter phase II study of radium-223 chloride for the palliation of painful bone metastases in patients with castration-resistant prostate cancer. Eur J Cancer. 2012 Mar;48(5):678-86. doi: 10.1016/j.ejca.2011.12.023. Epub 2012 Feb 15.

    PubMed 22341993

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radium-223 dichloride (BAY88-8223) in people with Hormone Refractory Prostate Cancer and Bone Metastases, run by Bayer.

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 21 inclusion and 14 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 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

Pain Assessment (using a 100mm Visual Analogue Scale) (time frame: 16 weeks). 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 NCT00667199, which also lists 1 linked publication.

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 19 Apr 2023.

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