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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06273345
Other study ID # IOV-PR-1-2022-OLIGOS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 23, 2023
Est. completion date January 2025

Study information

Verified date February 2024
Source Istituto Oncologico Veneto IRCCS
Contact Angelo Porreca, MD
Phone 0423 421321
Email angelo.porreca@iov.veneto.it
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The proposed study consists of a multicentre prospective observational study involving patients with oligometastatic prostatic neoplasia defined according to CHAARTED criteria. The aim of the study is the creation of a registry including patients with newly diagnosed OMPCa, belonging to the main urological centres in the Triveneto region, in order to evaluate the oncological outcomes and the impact on the quality of life of local treatment of the primary neoplasm (surgical or radiotherapy) in addition to systemic hormonal treatment (ADT as monotherapy or in combination with Docetaxel/androgen receptor signal inhibitors (ARTA)). The above criteria define 'high metastatic volume' disease with the following parameters - ≥ 4 bone metastases, including at least one outside the spine and pelvis - Presence of visceral metastases Consequently, patients included in the study should not have the above-mentioned characteristics.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date January 2025
Est. primary completion date January 2025
Accepts healthy volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of new-onset prostate neoplasia (any risk category according to EAU guidelines). - Histological confirmation of disease by prostate biopsies. Absence of neuroendocrine differentiation - Low volume of metastatic disease defined according to CHAARTED study criteria (< of 4 bone metastases, absence of visceral metastases) - Patients without previous treatment of primary malignancy (e.g. previous radical prostatectomy, previous RT) - Patients treated with systemic therapy (ADT as monotherapy or in combination) for less than 6 months prior to enrolment - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Patients eligible for local treatment of primary malignancy and concomitant systemic therapy - Signature of informed consent Exclusion Criteria: - Inability or unwillingness to give written informed consent - High volume metastatic disease defined according to CHARTEED criteria - ECOG performance status > 1 - Patients included in other clinical trials - Contraindications to hormone/systemic therapy administration - Previous treatment of primary tumour (RP, RT or other treatment of primary tumour)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Casa di Cura Abano Terme Abano Terme Padova
Italy Ospedale di Bassano Del Grappa Bassano Del Grappa Vicenza
Italy Ospedale di Bressanone Bressanone Bolzano
Italy Ospedale di Dolo Dolo Venezia
Italy Ospedale dell'Angelo - Mestre Mestre
Italy Azienda Ospedale Università Padova Padova
Italy Istituto Oncologico Veneto IRCCS Padova
Italy Ospedale MAter Salutis - Legnago Padova
Italy Ospedali Riuniti Padova Sud Padova
Italy Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) Trieste
Italy Presidio Ospedaliero Universitario Santa Maria della Misericorida (ASU FC) Udine
Italy Azienda Ospedaliera Universitaria Integrata - Verona Verona

Sponsors (1)

Lead Sponsor Collaborator
Istituto Oncologico Veneto IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival (OS) Impact of primary tumour treatment in addition to systemic therapy on overall survival (OS) in patients with new-onset oligometastatic prostate neoplasia. from the start date of the chosen treatment to the date of the subject's death from any cause, up to 3 years
Secondary Cancer-specific survival CSS is defined as the time (quantified in months) from the start date of the chosen treatment and the subject's death caused by the malignancy. from the start date of the chosen treatment to the subject's death caused by the malignancy, up to 3 years.
Secondary CRPCa development Serum testosterone levels < 50 ng/dL or 1.7 nmol/L in association with biochemical progression or radiological progression From the date of randomization up to 3 years
Secondary Radiological progression-free survival Definition of radiological progression (r-PFS): time from treatment start date to radiological progression (appearance of two or more new lesions on bone scintigraphy or appearance of visceral lesions). From the treatment start date to radiological progression, up to 3 years
Secondary Quality of life assessment Assessment of QoL using the EuroQol 5-dimensional 5-level questionnaire (EQ-5D-5L)19 From admission to discharge, assessed up to 3 years
Secondary Quality of life assessment Assessment of QoL using the EPIC-26 Short Form questionnaire. From admission to discharge, assessed up to 3 years
Secondary Complications Evaluation of complications related to radiotherapy treatment, according to CTCAE v5.0 and surgical treatment, evaluated according to the Clavien Dindo classification From admission to discharge, assessed up to 3 years
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