A study investigating the safety of radium-223 dichloride, given as a 50kBq/kg dose every four weeks to patients with castration-resistant prostate cancer that has spread to bone, who have already been treated with a course of six doses of radium-223 dichloride 50kBq/kg every four weeks.
- Conditions
- Castration Resistant Prostate cancer patients with bone metastasesMedDRA version: 19.0Level: LLTClassification code 10036916Term: Prostate cancer stage DSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-003046-17-DE
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 40
- Histologically or cytologically confirmed adenocarcinoma of the prostate at any given point in time during disease history
- CRPC (castration-resistant prostate cancer) with clinical or radiologically confirmed bone progression
- Treatment with 6 injections of radium-223 dichloride 50 kBq/kg and no evidence of progression to bone (according to Prostate Cancer Clinical Trials Working Group 2 [PCWG2] criteria) during the first course of treatment
- Re-treatment with radium-223 dichloride is indicated based on one or
more of the following:
o Radiological progression (according to PCWG2 criteria) in bone after the initial course of radium-223 dichloride treatment or
o Clinical progression defined as:
- Confirmed rising PSA (2 subsequent values showing PSA increase [a minimum value of 2 ng/mL {µg/L}], at least 1 week apart) after the initial course of radium-223 dichloride treatment or
- Substantial worsening of pain after the initial course of radium-223 dichloride treatment, based on the investigator’s determination. This pain should be due to the existing bone metastasis.
- Signed written informed consent prior to participating in any study related procedures. Willing and able to comply with the protocol, including follow-up visits and examinations
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
- History of a radium-223 dichloride-related serious adverse event (SAE) or CTCAE Grade 3 or 4 adverse event (AE) during or after the initial course of radium-223 dichloride treatment that led to the discontinuation of treatment
- Less than 30 days from the last dose administered in the initial course of radium-223 dichloride treatment
- Visceral metastases 1 cm or greater in largest diameter and / or requiring local or systemic therapeutic intervention, as assessed by abdominal and pelvic magnetic resonance imaging (MRI) / computed tomography (CT) scan and / or chest X-ray within 30 days of the start of treatment
- Lymphadenopathy with lymph nodes exceeding 6 cm in short-axis diameter and / or requiring local or systemic therapeutic intervention. Enlarged lymph nodes of any size if the lymphadenopathy is thought to be a contributor to concurrent hydronephrosis
- Current central nervous system (CNS) metastases
- Chronic conditions associated with non-malignant abnormal bone growth (e.g., confirmed Paget’s disease of bone)
- Treatment with chemotherapy after the initial course of radium-223 dichloride treatment
- Prior hemibody external radiotherapy
- Prior systemic radiotherapy with strontium-89, samarium-153, rhenium-186, or rhenium-188
- Any other serious illness or medical conditions
-- Crohn’s disease or ulcerative colitis
-- History of documented bone marrow dysplasia
-- Unmanageable fecal incontinence
- Imminent or established spinal cord compression based on clinical findings and / or MRI that has not yet been treated
- Other malignancy treated within the last 3 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method