Clinical trial NCT03223727: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer Metastatic
Bone Metastases
Keywords: Radium-223
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2017-07-21
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men with prostate cancer and bone metastasis, which are to be treated with Radium-223.

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 criteria: 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.

Primary outcomes:
measure: Efficacy of treatment on pain outcomes, as mentioned by the patient
timeFrame: through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
measure: Efficacy of treatment by patient records
timeFrame: through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
Secondary outcomes:
measure: Symptomatic Skeletal Event
timeFrame: through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
measure: Clinical Parameters assessed by the WHO PS.
timeFrame: through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
measure: Subsequent therapy after Radium-223: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
measure: Biomarkers
timeFrame: through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Intitute
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis & Vlietland
Study officials:
affiliation: The Netherlands Cancer Institute
name: Andre Bergman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: