Radium-223 Dichloride (BAY88-8223) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

Sponsor

Bayer (Industry)

Overall Status

No longer available

CT.gov ID

NCT01516762

Collaborator

(none)

Locations

Study Details

Study Description

Brief Summary

This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC patients diagnosed with symptomatic bone metastasis and to collect additional short and long term safety data on the product.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms	Drug: Radium-223 dichloride (BAY88-8223)

Study Design

Study Type:

Expanded Access

Official Title:

Radium-223 Chloride (BAY88-8223) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Inclusion Criteria:

Age ≥ 18 years
Histologically or cytologically confirmed prostate cancer
Patients diagnosed with symptomatic progressive bone predominant metastatic CRPC/HRPC with at least 2 skeletal metastases on imaging with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed)
Symptomatic is defined as either
Regular (not occasional) use of analgesic medication for cancer related bone pain (≥ level 1; World Health Organization [WHO] ladder for cancer pain), or
Treatment with external beam radiation therapy (EBRT) for bone pain (the EBRT should be within the last 12 weeks before treatment)
Progressive disease is defined either by:
The appearance of new bone lesions. If progression is based on new lesion(s) on imaging only without an increase in prostate specific antigen (PSA), then PSA values from 3 assessments within the last 6 months must be provided; OR
In the absence of new bone lesions, 2 subsequent increases in serum PSA over previous reference value, which should not be more than 6 months before screening, each measured at least 1 week apart with the last PSA ≥ 5 ng/mL. (The reference value time point 1, is defined as the last PSA measured before increases are documented, with subsequent values obtained a minimum of 1 week apart. If the PSA at time point 3 is greater than the PSA at time point 2, then eligibility has been met. If the PSA at time point 3 is not greater than the PSA at time point 2 but, the PSA value at time point 4 and/or time point 5 is greater than the PSA at time point 2, the patient is eligible assuming that other criteria are met).
No intention to use cytotoxic chemotherapy within the next 6 months
Life expectancy ≥ 6 months
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
Adequate hematological, liver, and renal function
Absolute neutrophil count (ANC) ≥ 1.5 x10^9/L
Platelet count ≥ 100 x10^9/L
Hemoglobin ≥ 10.0 g/dL (100 g/L; 6.2 mmol/L)
Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
Creatinine ≤ 1.5 x ULN
Albumin > 25 g/L *Any bone imaging techniques as per institutional standard of care

Exclusion Criteria:

Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period or follow-up
Eligible for first course of docetaxel, i.e., patients who are fit enough, willing, and who are located where treatment with docetaxel is available
Treatment with cytotoxic chemotherapy within previous 4 weeks prior to screening, or failure to recover from adverse events (AEs) due to cytotoxic chemotherapy administered more than 4 weeks previous prior to screening (however, ongoing neuropathy is permitted)
Prior hemibody external radiotherapy is excluded. Patients who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for hemoglobin, absolute neutrophil count, and platelets
Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium-223 dichloride) for the treatment of bony metastases
Other malignancy treated within the last 3 years (except non melanoma skin cancer or low-grade superficial bladder cancer)
Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) (or other imaging modality based on institutional standard of care)
Presence of brain metastases
Lymphadenopathy exceeding 6 cm in short-axis diameter
Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis.
Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Patients with history of spinal cord compression should have completely recovered.
Any other serious illness or medical condition, such as but not limited to:
Any infection ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade 2
Cardiac Failure New York Heart Association (NYHA) Class III or IV
Crohn's disease or ulcerative colitis
Bone marrow dysplasia
Fecal incontinence

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Birmingham	Alabama	United States	35233
2	Phoenix	Arizona	United States	85040
3	Scottsdale	Arizona	United States	85260
4	Greenbrae	California	United States	94904
5	La Jolla	California	United States	92093
6	San Francisco	California	United States	94143
7	Stanford	California	United States	94305
8	Aurora	Colorado	United States	80045
9	Newark	Delaware	United States	19718
10	Washington	District of Columbia	United States	20007
11	Washington	District of Columbia	United States	20060
12	Fort Myers	Florida	United States	33901
13	Miami Beach	Florida	United States	33140
14	Tampa	Florida	United States	33612
15	Atlanta	Georgia	United States	30322
16	Honolulu	Hawaii	United States	96813-2413
17	Goshen	Indiana	United States	46526
18	Iowa City	Iowa	United States	52242
19	New Orleans	Louisiana	United States	70112
20	Shreveport	Louisiana	United States	71103
21	Baltimore	Maryland	United States	21201-1595
22	Baltimore	Maryland	United States	21229
23	Baltimore	Maryland	United States	21287
24	Bethesda	Maryland	United States	20889
25	Rockville	Maryland	United States	20850
26	Boston	Massachusetts	United States	02114
27	Boston	Massachusetts	United States	02215
28	Ann Arbor	Michigan	United States	48109-0028
29	Detroit	Michigan	United States	48201
30	Detroit	Michigan	United States	48202
31	Minneapolis	Minnesota	United States	55455
32	St. Louis	Missouri	United States	63110
33	Las Vegas	Nevada	United States	89169
34	New Brunswick	New Jersey	United States	08903-2681
35	Newark	New Jersey	United States	07103
36	New Hyde Park	New York	United States	11040-1496
37	New York	New York	United States	10016
38	New York	New York	United States	10065
39	Syracuse	New York	United States	13210
40	Durham	North Carolina	United States	27710
41	Raleigh	North Carolina	United States	27607
42	Cleveland	Ohio	United States	44195
43	Columbus	Ohio	United States	43212
44	Springfield	Oregon	United States	97477
45	Philadelphia	Pennsylvania	United States	19107
46	Philadelphia	Pennsylvania	United States	19111-2497
47	Philadelphia	Pennsylvania	United States	19401
48	Pittsburgh	Pennsylvania	United States	15213
49	Myrtle Beach	South Carolina	United States	29572
50	Myrtle Beach	South Carolina	United States	29577
51	Nashville	Tennessee	United States	37232
52	Houston	Texas	United States	77030
53	Plano	Texas	United States	75093
54	San Antonio	Texas	United States	78229
55	Temple	Texas	United States	76508
56	Hampton	Virginia	United States	23666
57	Norfolk	Virginia	United States	23507
58	Seattle	Washington	United States	98122
59	Wheeling	West Virginia	United States	26003
60	Milwaukee	Wisconsin	United States	53226-3596