NCT04110782

Brief Summary

The investigators provided a multicenter analysis aiming to investigate, in a clinical practice setting, the prognostic relevance of previous primary radical prostatectomy (RP) or external beam radiotherapy (RT) in terms of Overall Survival as opposed to patients with no primary treatment performed, in a cohort of patients enrolled in 223-Ra treatment for mCRPC. 223-Ra has been administered from investigators according to the current label authorization and all patients underwent 223-Ra treatment, until disease progression or unacceptable toxicity.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

3.8 years

First QC Date

June 20, 2019

Last Update Submit

September 30, 2019

Conditions

Prostate Cancer

Keywords

223-Radium-diclorideRadical prostatectomyoverall survival

Outcome Measures

Primary Outcomes (1)

  • Evaluation of overal survivall

    The survival function, possibly stratified by categorical covariates of interest, was computed using the Kaplan-Meier product-limit estimator.

    From date of first 223Ra administration until the date of death from any cause or the date of the first documented progression disease, assessed up to 48 months

Study Arms (1)

Radium223

Other: Radium223

Interventions

Radium223OTHER

55 kBq/ Kg

Radium223

Eligibility Criteria

Sexmale(Gender-based eligibility)
Gender Eligibility DetailsProstate cancer
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

mCRPC patients admitt to Radium223 Therapy

You may qualify if:

  • histological confirmation of prostatic adenocarcinoma, at least two symptomatic bone secondary lesions detected by bone scan and no known visceral metastases, except for malignant lymphadenopathy with less than 3 cm in the short axis diameter

You may not qualify if:

  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) score \>2 and inadequate hematological, hepatic and renal function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Umberto I

Rome, 00161, Italy

RECRUITING

Related Publications (2)

  • Parker C, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fossa SD, Chodacki A, Wiechno P, Logue J, Seke M, Widmark A, Johannessen DC, Hoskin P, Bottomley D, James ND, Solberg A, Syndikus I, Kliment J, Wedel S, Boehmer S, Dall'Oglio M, Franzen L, Coleman R, Vogelzang NJ, O'Bryan-Tear CG, Staudacher K, Garcia-Vargas J, Shan M, Bruland OS, Sartor O; ALSYMPCA Investigators. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013 Jul 18;369(3):213-23. doi: 10.1056/NEJMoa1213755.

    PMID: 23863050BACKGROUND

  • Parker CC, Coleman RE, Sartor O, Vogelzang NJ, Bottomley D, Heinrich D, Helle SI, O'Sullivan JM, Fossa SD, Chodacki A, Wiechno P, Logue J, Seke M, Widmark A, Johannessen DC, Hoskin P, James ND, Solberg A, Syndikus I, Kliment J, Wedel S, Boehmer S, Dall'Oglio M, Franzen L, Bruland OS, Petrenciuc O, Staudacher K, Li R, Nilsson S. Three-year Safety of Radium-223 Dichloride in Patients with Castration-resistant Prostate Cancer and Symptomatic Bone Metastases from Phase 3 Randomized Alpharadin in Symptomatic Prostate Cancer Trial. Eur Urol. 2018 Mar;73(3):427-435. doi: 10.1016/j.eururo.2017.06.021. Epub 2017 Jul 11.

    PMID: 28705540BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radium-223

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Giuseppe De Vincentis, MD, PhD

    University of Roma La Sapienza

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe De Vincentis, MD, PhD

CONTACT

00390649978596giuseppe.devincentis@uniroma1.it

VIVIANA FRANTELLIZZI, MD

CONTACT

00390649978573viviana.frantellizzi@uniroma1.it

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 20, 2019

First Posted

October 1, 2019

Study Start

September 1, 2015

Primary Completion

June 1, 2019

Study Completion

January 1, 2020

Last Updated

October 1, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

Clinical and anagraphical data

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
starting 12 months after publication

Locations

IT(1)