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Phase 1, Open-label, Single Ascending-dose Study to Assess Safety, Pharmacokinetics, Biodistribution and Radiation Dosimetry of Intravenous Doses of Alpharadin™ Injection (Radium-223 Chloride) in Patients With HRPC and Skeletal Metastases

Phase 1
18 Years
Not Enrolling
Prostate Cancer, Metastases, Pharmacokinetics

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Trial Information

Phase 1, Open-label, Single Ascending-dose Study to Assess Safety, Pharmacokinetics, Biodistribution and Radiation Dosimetry of Intravenous Doses of Alpharadin™ Injection (Radium-223 Chloride) in Patients With HRPC and Skeletal Metastases

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

Inclusion Criteria:

1. Must be ≥18 years of age.

2. Have histologically or cytologically evidence of adenocarcinoma of the prostate.

3. Have progressive castrate metastatic disease as shown by at least one of the

Imaging modalities:

Radionuclide Bone Scan: New osseous lesions. MRI or CT: At least a 20% increase in
the sum of the LD of target lesions. or

Biochemical progression:

A minimum of three rising PSA values from a baseline that are obtained 1 week or more
apart, or 2 measurements 2 or more weeks apart.

4. Have skeletal metastases confirmed by bone scintigraphy within the last 4 weeks.
Evidence of at least 2 bone metastases on bone scan.

5. Have castrate levels of testosterone (<50 ng/ml). Treatment to maintain castrate
levels of testosterone must be continued.

6. Patients who have failed initial hormonal therapy using either an orchiectomy or a
GnRH agonist in combination with an antiandrogen must first progress through
antiandrogen withdrawal prior to being eligible. The minimum timeframe to document
failure of anti-androgen withdrawal will be four weeks.

7. Have Karnofsky performance status ≥60%.

8. Have a life expectancy ≥6 months.

9. Have the following laboratory requirements:

- White Blood Count (WBC) ≥3,000/mm3

- Absolute Neutrophil Count (ANC) ≥1,500/ mm3

- Platelet (PLT) ≥100,000/ mm3

- Hemoglobin (HGB) ≥10 mg/dl

- Bilirubin ≤2.0 mg/dl (unless the patient has Gilbert's syndrome)

- AST and ALT ≤2,5 times upper institutional limit of the normal range

- Serum creatinine ≤2.0 mg/dl

10. Must be able and willing to sign an informed consent indicating that he is aware of
the investigational nature of this study in keeping with the policies of the
institution and have provided written authorization for use and disclosure of
protected health information.

11. Must be willing and able to comply with the protocol, and agrees to return to the
hospital for follow-up visits and examination.

Exclusion Criteria:

1. Have received an investigational drug within 4 weeks prior to the administration of
Alpharadin, or is scheduled to receive one during the treatment and post-treatment

2. Have received chemo-, immunotherapy, or external radiotherapy within the last 4 weeks
prior to administration of study drug, or has not recovered from acute adverse events
as a result of such therapy.

3. Have received prior hemibody external radiotherapy*.

4. Have a need for immediate external radiotherapy.

5. Have received systemic radiotherapy with radium-223, strontium-89, samarium-153,
rhenium-186 or rhenium-188 for the treatment of bony metastases within the last 24
weeks prior to administration of study drug.

6. When receiving bisphosphonates, have changed the dose within 4 weeks before
administration of study drug.

7. Have started or stopped systemic steroids within a week prior to study drug
administration, or are expected to be subject to changes in the systemic steroid

8. Have imminent or established spinal cord compression based on clinical findings
and/or MRI.

9. Have other currently active (relapse within the last 3 years) malignancy (except
non-melanoma skin cancer) that are not prostate cancer metastases

10. Have small cell carcinoma.

11. Have predominant visceral metastases (≥ 3 lung or liver lesions) or symptomatic
lymph-adenopathy (scrotal or pedal edema).

12. Any other serious illness or medical condition, for example:

- any uncontrolled infection

- any patient who has clinical heart failure severe enough to cause marked
limitation of activity, and who is only comfortable at rest; or any patient who
has heart failure more severe than this (NYHA Heart Failure Class III or IV)

- Crohn's disease or ulcerative colitis

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

All safety data, including adverse events, occurrence of treatment-emergent adverse events, changes in laboratory variables, vital signs, ECG, physical examination, long term radiation toxicity, including results of bone marrow biopsy

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Michael J. Morris, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2008

Completion Date:

October 2010

Related Keywords:

  • Prostate Cancer
  • Metastases
  • Pharmacokinetics
  • Biodistribution
  • Radiation dosimetry
  • Pharmacokinetics
  • Safety
  • Neoplasm Metastasis
  • Prostatic Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021