--- title: Treatment Outcomes in a Non-study Population of Symptomatic mCRPC Patients Treated With Radium-223 nct_id: NCT03223727 overall_status: COMPLETED sponsor: The Netherlands Cancer Institute study_type: OBSERVATIONAL primary_condition: Prostate Cancer Metastatic countries: Netherlands canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03223727.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03223727" ct_last_update_post_date: 2023-04-18 last_seen_at: "2026-05-12T07:02:59.985Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Treatment Outcomes in a Non-study Population of Symptomatic mCRPC Patients Treated With Radium-223 **Official Title:** Registry of Treatment Outcomes in a Non-study Population of Symptomatic Metastasized Castration Resistant Prostate Cancer (mCRPC) Patients Treated With Radium-223 **NCT ID:** [NCT03223727](https://clinicaltrials.gov/study/NCT03223727) ## Key Facts - **Status:** COMPLETED - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 100 - **Lead Sponsor:** The Netherlands Cancer Institute - **Collaborators:** Bayer - **Conditions:** Prostate Cancer Metastatic, Bone Metastases - **Start Date:** 2015-10-30 - **Completion Date:** 2023-02-03 - **CT.gov Last Update:** 2023-04-18 ## Brief Summary This registry aims to evaluate the efficacy of Rad-223 treatment in a non-study population of CRPC patients treated earlier with Docetaxel and patients not treated earlier with Docetaxel and efficacy of the first subsequent therapy. The indication for treatment with Radium-223 will be at the physician's decision. All patients treated with Radium-223 can be included in this registry. The registry only dictates the collection of base line characteristics, expansion of regular blood tests and patient reported pain scores. ## Detailed Description Serum and blood markers of bone metabolism will be evaluated at Base Line, 1st, 2nd, 3rd and 6th (or last) Radium- 223 treatment. Every blood draw prior to Radium-223 treatment At baseline, tests include (but not restricted to): Testosterone, vitamin D-25-OH (Calciferol), C-reactive protein, Rank Ligand, IL6, BSAF, P1NP and CTX. Patients need to be fasting when blood is collected. (2x8,5 ml gel tube; Limited to 100 patients in selected centres). Before 2nd, 3rd, 4th and 6th (or last) Radium-223 treatment, tests include (but not restricted to): C-reactive protein, Rank, Ligand, IL6, BSAF, P1NP and CTX. Patients need to be fasting when blood is collected. (2x8,5 ml gel tube; Limited to 100 patients in selected centers). Moreover, levels of osteoclast precursors (CD34+) will be evaluated (10 ml heparinized blood) prior to the first Radium-223 treatment, 3rd and last treatment (Limited to 100 patients in selected centres). All above-mentioned blood collections will be from the same venipuncture as standard clinical labs. Experimental assessments will be evaluated for their value as biomarkers of treatment outcome. ## Eligibility - **Minimum age:** 18 Years - **Sex:** MALE - **Healthy Volunteers:** No ``` Inclusion Criteria: * At the physicians discretion * Age 18 year and older. * Written informed consent Exclusion Criteria: * Previous treatment with Radium-223. * Participation in another Radium-223 study. ``` ## Interventions - **Blood tests** (DIAGNOSTIC_TEST) — Blood tests for several bone markers (see summary) ## Primary Outcomes - **Efficacy of treatment on pain outcomes, as mentioned by the patient** _(time frame: through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment))_ — Evaluate Radium-223 treatment efficacy by patient, by several questionnaires (FACT-P, BPI-S and use of painmedication). - **Efficacy of treatment by patient records** _(time frame: through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment))_ — But also by patient records (records of bonescans, CT scans, blood measurements, out-patient clinic visits). All of these assessments will be combined to come to a final reported value (Progressive disease, stable disease, partial remission or complete remission) ## Secondary Outcomes - **Symptomatic Skeletal Event** _(time frame: through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment))_ - **Clinical Parameters assessed by the WHO PS.** _(time frame: through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment))_ - **Number of participants with treatment-related adverse events as assessed by CTCAE v4.0** _(time frame: through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment))_ - **Subsequent therapy after Radium-223: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0** _(time frame: through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment))_ - **Biomarkers** _(time frame: through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment))_ ## Locations (2) - The Netherlands Cancer Intitute, Amsterdam, Netherlands - Franciscus Gasthuis & Vlietland, Rotterdam, Netherlands ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.the netherlands cancer intitute|amsterdam||netherlands` — added _(2026-05-12)_ - `locations.franciscus gasthuis & vlietland|rotterdam||netherlands` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT03223727.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT03223727* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*