Analysis of the efficacy and safety of Radium223 in men with advanced prostate cancer

Prospective, single center study on radium-223 dichloride in patients with castration-resistant prostate cancer

Status

Recruiting

Phases

Phase 3

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN12835467

Enrollment

Registered

2018-01-24

Start date

2018-03-01

Completion date

Unknown

Last updated

2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic castration resistant prostate cancer with bone metastases Cancer Metastatic castration resistant prostate cancer with bone metastases

Interventions

Participants are treated with injections of radium-223 dichloride [55 kBq/kg body weight (BW)] every 4 weeks (Q4W) for up to six injections. The administration of radium-223 in men with advanced pro

EAU, ASCO, etc). After a multidisciplinary team discussion and a reevaluation in the nuclear medicine deptartment, the participants are treated with radium-223 dichloride. The participants are treat

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Patients with progressive mCRPC and castrate levels of testosterone (<50 ng/dl) 2. Chemonaive or postchemotherapy 3. Symptomatic bone metastases, treated with Radium 223

Exclusion criteria

Exclusion criteria: 1. Patient 3 4. Patients with exclusive visceral metastases 5. Patient with non castrated testosterone levels 6. Patient concomitant use of abiraterone acetate, enzalutamide, docetaxel, cabazitaxel, mitoxantrone

Design outcomes

Primary

Measure	Time frame
Overall survival (defined as the time between treatment initiation and either the date of death or the last follow-up for surviving patients is measured using the patient records at monthly follow ups.	—

Secondary

Measure	Time frame
1. Treatment-related toxicity is measured using the National Cancer Institute Common Terminology Criteria for Adverse Events 4.02 toxicity scale monthly follow ups 2. Biochemical bone markers (alkaline phosphatase and bone alkaline phosphatase) and laboratory exams variation is measured using routine laboratory exams at monthly follow ups 3. Progression free survival (PFS) (defined as the time from the first dose of Radium 223 to the first clinical (pain, general status) or new radiographic event) measured using patients notes at monthly follow ups 4. Performance status is measured using the Eastern Cooperative Oncology Group (ECOG) and the pain by the Brief Pain Inventory scale at monthly follow ups	—

Measure

Time frame

1. Treatment-related toxicity is measured using the National Cancer Institute Common Terminology Criteria for Adverse Events 4.02 toxicity scale monthly follow ups 2. Biochemical bone markers (alkaline phosphatase and bone alkaline phosphatase) and laboratory exams variation is measured using routine laboratory exams at monthly follow ups 3. Progression free survival (PFS) (defined as the time from the first dose of Radium 223 to the first clinical (pain, general status) or new radiographic event) measured using patients notes at monthly follow ups 4. Performance status is measured using the Eastern Cooperative Oncology Group (ECOG) and the pain by the Brief Pain Inventory scale at monthly follow ups

—

Countries

Italy

Contacts

Public ContactManlio Mascia

manlio.mascia@ausl.pe.it+39 3202212153

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026