A Study of Alpharadin With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer (CRPC)

Bayer

Status and phase: Completed; Phase 2; Phase 1

Conditions: Castration-Resistant Prostate Cancer; Bone Metastases

Treatments: Drug: Radium-223 dichloride (Xofigo, BAY88-8223); Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01106352

BC1-10 (Other Identifier)

15469

2011-000822-31 (EudraCT Number)

Details and patient eligibility

About

The main purpose of this study is to establish a recommended dose of Alpharadin to be used in combination with docetaxel in patients with bone metastases from castration-resistant prostate cancer and to investigate safety and explore efficacy of the recommended dose.

Full description

The trial was initially conducted and submitted by Algeta ASA. After acquiring Algeta, Bayer is now the sponsor.

Enrollment: 70 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed adenocarcinoma of the prostate.
• Two or more bone metastases (hot spots) confirmed by bone scintigraphy within 8 weeks prior to study entry
• Known castration-resistant disease
• Karnofsky Performance Status (KPS): ≥70% within 14 days before start of study treatment (ECOG 1)
• Life expectancy at least 6 months.
• Acceptable hematology and serum biochemistry screening values
• Eligible for use of docetaxel according to the product information (package insert or similar).

Exclusion criteria

• Has received an investigational therapeutic drug within the last 4 weeks prior to start of study treatment, or is scheduled to receive one during the treatment period.
• Has received external radiotherapy within the last 4 weeks prior to start of study treatment.
• Has an immediate need for radiotherapy.
• Has received prior hemibody external radiotherapy .
• Has received systemic radiotherapy (e.g. samarium, strontium etc.) for the treatment of bone metastases.
• Has received cytotoxic chemotherapy within the last 4 weeks prior to start of study treatment, or has not recovered to grade 1 or 0 from adverse events due to cytotoxic chemotherapy administered more than 4 weeks earlier.
• Has received more than ten previous infusions of docetaxel.
• Previous known experience of grade ≥ 3 docetaxel related toxicities or docetaxel toxicity related dose interruption or discontinuation.
• Previous use of G-CSF for persistent neutropenia after docetaxel treatment.
• Has received blood transfusion or erythropoietin (EPO) within the last 4 weeks prior to start of study treatment.
• Has received prior treatment with Alpharadin.
• Malignant lymphadenopathy exceeding 3 cm in short-axis diameter.
• Symptomatic nodal disease, i.e. scrotal, penile or leg edema.
• Visceral metastases from CRPC (>2 lung and/or liver metastases [size ≥2cm]), as assessed by CT scan or MRI of the chest/abdomen/pelvis within the last 8 weeks prior to start of study treatment.
• Uncontrolled loco-regional disease.
• Other primary tumor (other than CRPC) including haematological malignancy present within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer).
• Has imminent or established spinal cord compression based on clinical findings and/or MRI.
• Unmanageable fecal incontinence

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Radium-223 dichloride (Xofigo, BAY88-8223) + docetaxel

Experimental group

Description:

Alpharadin (Radium-223 dichloride) is administered intravenously as a bolus injection. In the randomized phase IIa part of the protocol, the dose established in the dose-escalation part of the protocol (Phase I) will be used, i.e. 5 doses of 50 kBq/kg b.w. every 6 weeks in combination with the approved step-down dose of docetaxel (60 mg/m\^2) administered intravenously every 3 weeks with 5 mg prednisone twice a day continuously and pre-medication with dexamethasone.

Treatment:

Drug: Docetaxel

Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

Docetaxel

Active Comparator group

Description:

Docetaxel (75 mg/m2) will be administered intravenously every 3 weeks with 5 mg prednisone twice a day continuously and pre-medication with dexamethasone. Step-down to 60 mg/m\^2 is allowed as per the approved docetaxel label.

Treatment:

Drug: Docetaxel