Radical Prostatectomy and External Beam Radiotherapy in mCRPC With 223Radium-dicloride (RaProRad)

Prostate Cancer Clinical Trial

— RaProRad  

Official title:

Evaluation of Previeus Radical Prostatectomy and/or External Beam Radiotherapy as Protective Factors in mCRPC Patients Treated With 223Radium-dicloride and Correlation With Overall Survival: an Italian Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04110782
• Other study ID #: MP2018SAP
• Status: Recruiting
• Start date: September 2015
• Est. completion date: January 2020

Study information

• Verified date: September 2019
• Source: Azienda Policlinico Umberto I
• Contact: Giuseppe De Vincentis, MD, PhD
• Phone: 00390649978596
• Email: giuseppe.devincentis[@]uniroma1.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 2020
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Radium223
55 kBq/ Kg

Locations

Country	Name	City	State
Italy	Policlinico Umberto I	Rome

Sponsors (6)

Lead Sponsor	Collaborator
Azienda Policlinico Umberto I	Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo, Ospedale Civile Spirito Santo, Università degli Studi di Bari Aldo Moro, Università degli Studi di Sassari, University of Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Parker C, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fosså 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, Franzén L, Coleman R, Vogelzang NJ, O'Bryan-Tear CG, Staudacher K, Garcia-Vargas J, Shan M, Bruland ØS, 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. — View Citation

Parker CC, Coleman RE, Sartor O, Vogelzang NJ, Bottomley D, Heinrich D, Helle SI, O'Sullivan JM, Fosså 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, Franzén L, Bruland ØS, 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. 2017 Jul 10. pii: S0302-2838(17)30516-X. doi: 10.1016/j.eururo.2017.06.021. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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