Metastatic castration sensitive prostate cancer
Conditions
Interventions
Trade Name: Xofigo 1000 kBq/mL solution for injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Radium 223 dichloride
CAS Number: 444811-40-9
Other descriptive name: Xofigo
Conc
Sponsors
Belfast Health and Social Care Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained prior to any study-related procedures 2. Histologically confirmed prostate cancer stage T1-4 N0-1, M1b 3. Patients with =3 bone metastases showing uptake at bone scintigraphy 4. WHO performance status 0 or 1. 5. Life expectancy of at least 12 months. 6. Age = 18years. 7. Absolute neutrophil count (ANC) = 1.5 x109/L 8. Platelet count = 100 x109/L 9. Hemoglobin =10.0 g/dL (100 g/L; 6.2 mmol/L) 10. Total bilirubin level = 1.5 x institutional upper limit of normal (ULN) 11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN 12. Creatinine = 1.5 x ULN 13. Albumin > 25 g/L 14. Patients, even if surgically sterilized (i.e. status post-vasectomy), who: - will abstain from intercourse - or must agree to use barrier contraception during and for 6 months after discontinuation of study treatment. If patient impregnates a woman while on treatment or within 3 months of discontinuing treatment, he should inform his treating physician immediately. 15. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial 16. 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: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Active uncontrolled bacterial, viral or fungal infection. 2. History of another malignancy within the last five years except adequately treated basal cell carcinoma of skin. 3. History of organ allografts requiring immunosuppressive therapy. 4. Serious uncontrolled concomitant disease. 5. Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period or follow-up 6. Received previous radiotherapy to > 25% of bone marrow, including hemibody radiation 7. Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium-223 chloride) for the treatment of bony metastases 8. Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) (or other imaging modality) 9. Imminent or history of spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI) 10. Any other serious illness or medical condition, such as but not limited to: i) Any infection = National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade 2 ii) Cardiac failure New York Heart Association (NYHA) III or IV iii) Crohn’s disease or ulcerative colitis iv) Bone marrow dysplasia v) Faecal incontinence vi) History of diverticulitis 11. Autologous bone marrow transplant or stem cell rescue within 4 months of study entry 12. Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity when clinically indicated or at the discretion of the investigator; however they may not be substituted for a required dose reduction.] [Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study entry or during the study]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In early metastatic prostate cancer is it feasible to deliver LHRH agonist therapy alongside external radiotherapy to prostate gland and pelvic lymph nodes and alongside intravenous radionuclide (Radium223) treatment without undue toxicity?;Secondary Objective: What effect does treatment as outlined in A10 have on blood markers of disease (PSA and ALP)? What effect does treatment as outlined in A10 have on disease as seen on radiographic studies (MRI)? What effect does treatment as outlined in A10 have on time to develop first Symptomatic Skeletal Event (SSE – defined as any of: first use of external beam radiotherapy to relieve skeletal symptoms; new symptomatic pathological vertebral or non-vertebral bone fracture; spinal cord compression; tumour-related orthopaedic surgical intervention.) What effect does treatment as outlined in A10 have on tumour cells detectable in blood?;Primary end point(s): Toxicity associated with concurrent treatment with LHRH agonist (hormone) injections, external beam radiotherapy to pelvis and intravenous Radium223 dichloride. ;Timepoint(s) of evaluation of this end point: Patients will be clinically assessed and complete EPIC radiotherapy toxicity assessment weekly during radiotherapy, then four weekly during Radium223 treatment phase. They will then be clinically assessed and complete EPIC radiotherapy toxicity assessment 8 weeks following last Radium223 injection and again at end of study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): What effect does treatment as outlined in A10 have on blood markers of disease? What effect does treatment as outlined in A10 have on disease as seen on radiographic studies (MRI)? What effect does treatment as outlined in A10 have on tumour cells detectable in blood? What effect does treatment as outlined in A10 have on time to develop first Symptomatic Skeletal Event (SSE – defined as any of: first use of external beam radiotherapy to relieve skeletal symptoms; new symptomatic pathological vertebral or non-vertebral bone fracture; spinal cord compression; tumour-related orthopaedic surgical intervention.);Timepoint(s) of evaluation of this end point: Blood markers of disease will be checked at baseline and prior to each cycle of Radium223 treatment (four weekly for six cycles in total). They will be checked again 8 weeks post last injection of Radium223 and again at end of study. Whole body MRI and bone scan will be performed at baseline and again 8 weeks following final injection of Radium223 and again at end of study. Peripheral blood will be checked for circulating tumour cells at baseline and prior to each cycle of Radium223 treatment (four weekly for six cycles in total). It will be checked again 8 weeks post last injection of Radium223 and again at end of study. | — |
Countries
United Kingdom
Contacts
Public ContactProf Joe O'Sullivan
Belfast Health and Social Care Trust
Outcome results
None listed