BAY88-8223, Does Response Study in HRPC Patients

NCT00667199 | Completed Phase 2

• 3 other identifiers: 15305BC1-032004-000299-15
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hormone Refractory Prostate Cancer; Bone Metastases

Keywords

Hormone Refractory Prostate Cancer; Bone Metastases; Radium-223; Palliation of bone pain

Outcome Measures

Primary Outcomes (2)

• Pain Assessment (using a 100mm Visual Analogue Scale)

  16 weeks

• Analgesic consumption

  16 weeks

Secondary Outcomes (4)

• 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

  16 weeks

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

  16 weeks

• 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.

  2 years

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

  2 years

Study Arms (4)

Radium-223 dichloride (Xofigo, BAY88-8223)-5kBq/kg

EXPERIMENTAL

Each 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.

Drug: Radium-223 dichloride (BAY88-8223)

Radium-223 dichloride (Xofigo, BAY88-8223)-25 kBq/kg

EXPERIMENTAL

Each 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.

Drug: Radium-223 dichloride (BAY88-8223)

Radium-223 dichloride (Xofigo, BAY88-8223)-50 kBq/kg

EXPERIMENTAL

Each 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.

Drug: Radium-223 dichloride (BAY88-8223)

Radium-223 dichloride (Xofigo, BAY88-8223)-100 kBq/kg

EXPERIMENTAL

Each 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.

Drug: Radium-223 dichloride (BAY88-8223)

Interventions

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.)

Radium-223 dichloride (Xofigo, BAY88-8223)-100 kBq/kg; Radium-223 dichloride (Xofigo, BAY88-8223)-25 kBq/kg; Radium-223 dichloride (Xofigo, BAY88-8223)-50 kBq/kg; Radium-223 dichloride (Xofigo, BAY88-8223)-5kBq/kg

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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 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)
• 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

Sponsors & Collaborators

• Bayer: lead

Related Publications (1)

• 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.

  PMID: 22341993 RESULT

MeSH Terms

Interventions

radium Ra 223 dichloride

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 28, 2008
• Study Start: May 30, 2005
• Primary Completion: April 1, 2008
• Study Completion: October 6, 2009
• Last Updated: April 19, 2023

Record last verified: 2023-04