OLIGOS: Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate

Oligometastatic Prostate Carcinoma Clinical Trial

— OLIGOS  

Official title:

OLIGOS: Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06273345
• Other study ID #: IOV-PR-1-2022-OLIGOS
• Status: Recruiting
• 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
• 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
• 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)

Related Conditions & MeSH terms

• Neoplasms
• Oligometastatic Prostate Carcinoma
• Prostatic Neoplasms

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