Clinical trial NCT04110782: Radical Prostatectomy and External Beam Radiotherapy in mCRPC With 223Radium-dicloride (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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Keywords: 223-Radium-dicloride
Radical prostatectomy
overall survival
Lead sponsor: Azienda Policlinico Umberto I
Sponsor class: OTHER
Collaborators: name: University of Bari Aldo Moro
name: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
name: University of Bologna
name: Università degli Studi di Sassari
name: Ospedale Civile Spirito Santo
First posted: 2019-10-01
Enrollment: 400
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: mCRPC patients admitt to Radium223 Therapy

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of overal survivall
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Umberto I
Study officials:
affiliation: University of Roma La Sapienza
name: Giuseppe De Vincentis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.