Patients with prostate cancer (PCa) who experience PSA progression and who are without detectable metastases following maximal local treatment consisting of radical prostatectomy (RP) + pelvic lymphadenectomy (PLND) and external beam radiotherapy (EBRT), or who present only with biochemical relapse after salvage lymph node dissection. Among patients with PSA relapse, those at major risk of metastatic progression will be studied.
Conditions
Interventions
Trade Name: Xofigo
Product Name: radium-223 dichloride
Pharmaceutical Form: Injection
Sponsors
UZLeuven
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Subjects must meet all the following criteria to be enrolled in the study: 1. Male aged 18 years or older with histological confirmation of prostatic adenocarcinoma. 2. Ability to provide informed consent and demonstration of willingness to follow all study phases. 3. Patient has to agree to use effective birth control method during and for 6 months after discontinuation of study treatment. 4. Patient is experiencing biochemical progression according to the following definition: a. PSA >0.2 ng/ml following maximal local treatment consisting of RP and PLND and adjuvant or salvage EBRT b. PSA >0.2 ng/ml following maximal local therapy consisting of salvage LND in patients treated primarily by RP + PLND and adjuvant or salvage EBRT. 5. Negative prognostic factors for metastatic progression. a. At least 1 of the risk factors should be present according to the following specific patient scenarios (for group at point 4a). • Salvage EBRT group (at least one of subsequent factors) - PSADT 25 g/l 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: Patients should not meet any of the following criteria: 1. Previous (ADT stopped at least 6 months before screening is allowed and serum testosterone assay should be evaluated in these patients to exclude levels 25% of bone marrow, including hemibody radiation. 3. Bone systemic therapy. 4. Other malignancy treated within the last 3 years. 5. Have any contraindication to imaging diagnostic procedures (Choline PET-CT,18F- Fluoride PET-CT and whole-body MRI). 6. Diagnosis of visceral and/or node and/or bone metastases at Choline PET-CT and/or 18F- Fluoride PET-CT and/or whole-body MRI. 7. Any other serious illness or medical condition, such as but not limited to: - Any major infection - Cardiac failure New York Heart Association (NYHA) III or IV - Crohn's disease or ulcerative colitis - Bone marrow dysplasia - Fecal incontinence 8. Medical condition or other elements that, in the investigator's opinion, could decrease the possibility to reach objectives of the study. 9. ECOG performance status =2 10. Life expectancy < 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the clinical safety/tolerability of Radium-223 treatment in patients affected by prostate cancer with biochemical relapse after maximal local treatment with high risk of metastatic progression. Safety and feasibility results could be used to plan an eventual phase II/III trial.;Secondary Objective: To assess biomarkers (PSA and bALP) and imaging progression to metastatic disease after Radium-223 treatment.;Primary end point(s): •Throughout the entire study, safety data will be collected as frequencies of different AE/SAE obtaining proportions of side effects in order to confirm tolerability patterns for the present study population. •Feasibility variables will be collected as: recruitment rates, consent rates, completion rates; completion of the study will test logistic, procedural and administrative feasibility.;Timepoint(s) of evaluation of this end point: •Throughout the entire study, safety data will be collected: from the first visit before the first dose and then every 4 weeks before drug injection (for a total of 6 injections). Every 3 months for 4 visits after the last dose and thyen every 3 months until the end of the study. •Feasibility variables will be collected at the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): evaluate PSA progression kinetics (median time to PSA progression). PSA progression is every confirmed (3 confirmatory PSA measurements, at least 1 week apart) PSA relapse with an increase superior to 50% from PSA nadir or confirmed PSA (3 confirmatory PSA measurements, at least 1 week apart) detectability when PSA became not more detectable. •bALP will be sampled during treatment and follow-up. bALP will be assessed as the proportion of patients who have biochemical values out of normality range. Time to bALP progression will be measured in order to better understand the bALP variations (median time to bALP progression) during the study. •Metastasis outbreak will be detected by medical imaging (Choline PETCT, 18F-Fluoride PET-CT and whole-body MRI ) before treatment and follow up with a maximum number of 2 imaging sessions (screening included).;Timepoint(s) of evaluation of this end point: •PSA will be assessed: from screening visit, at every visit time. •bALP will be assessed: from screening visit, at every visit time. •Metastasis outbreak will be detected by medical imaging (Choline PETCT, 18F-Fluoride PET-CT and whole-body MRI ) before treatment and follow up ( at PSA progression or end of follow up). | — |
Countries
Belgium
Contacts
Public ContactClinical Trial Center (CTC)
UZLeuven
Outcome results
None listed