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

NCT ID: NCT04110782

Last Updated: 2019-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2020-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Radium223

Radium223

Intervention Type OTHER

55 kBq/ Kg

Interventions

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Radium223

55 kBq/ Kg

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Bari Aldo Moro

OTHER

Sponsor Role collaborator

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

OTHER

Sponsor Role collaborator

University of Bologna

OTHER

Sponsor Role collaborator

Università degli Studi di Sassari

OTHER

Sponsor Role collaborator

Ospedale Civile Spirito Santo

OTHER

Sponsor Role collaborator

Azienda Policlinico Umberto I

OTHER

Sponsor Role lead

Responsible Party

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De Vincentis Giuseppe

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giuseppe De Vincentis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Roma La Sapienza

Locations

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Policlinico Umberto I

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giuseppe De Vincentis, MD, PhD

Role: CONTACT

[email protected]
00390649978596

VIVIANA FRANTELLIZZI, MD

Role: CONTACT

[email protected]
00390649978573

Facility Contacts

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Giuseppe De Vincentis, MD, PhD

Role: primary

[email protected]
00390649978596

VIVIANA FRANTELLIZZI, MD

Role: backup

[email protected]
00390649978573

References

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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.

Reference Type BACKGROUND
PMID: 23863050 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28705540 (View on PubMed)

Other Identifiers

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MP2018SAP

Identifier Type: -

Identifier Source: org_study_id

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