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

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.

Study Overview

• Status: Recruiting
• Conditions: Oligometastatic Prostate Carcinoma

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Angelo Porreca, MD; Phone Number: +39 0423 421321; Email: angelo.porreca@iov.veneto.it
• Study Contact Backup: Name: Gian Luca De Salvo, MD; Phone Number: +39 049 8215710; Email: gianluca.desalvo@iov.veneto.it

Study Locations

• Italy
  • Mestre, Italy
    • Recruiting
    • Ospedale dell'Angelo - Mestre
    • Contact: Francesco Gerardo Mandato, MD; Email: francesco.mandato@aulss3.veneto.it
    • Principal Investigator: Francesco Gerardo Mandato, MD
  • Padova, Italy, 35128
    • Recruiting
    • Istituto Oncologico Veneto IRCCS
    • Contact: Angelo Porreca, MD; Phone Number: +39 0423 421321; Email: angelo.porreca@iov.veneto.it
    • Contact: Gian Luca De Salvo, MD; Phone Number: +39 049 8215710; Email: gianluca.desalvo@iov.veneto.it
    • Principal Investigator: Angelo Porreca, MD
  • Padova, Italy
    • Not yet recruiting
    • Azienda Ospedale Universita Padova
    • Contact: Fabio Zattoni, MD; Email: fabio.zattoni@unipd.it
    • Principal Investigator: Fabio Zattoni, MD
  • Padova, Italy
    • Not yet recruiting
    • Ospedale MAter Salutis - Legnago
    • Contact: Pierpaolo Curti, MD; Phone Number: +39 0442 622387; Email: pierpaolo.curti@aulss9.veneto.it
    • Principal Investigator: Pierpaolo Curti, MD
  • Padova, Italy
    • Recruiting
    • Ospedali Riuniti Padova Sud
    • Principal Investigator: Nicola Zanovello, MD
    • Contact: Nicola Zanovello, MD; Email: nicola.zanovello@aulss6.veneto.it
  • Trieste, Italy
    • Not yet recruiting
    • Azienda sanitaria universitaria Giuliano Isontina (ASU GI)
    • Contact: Carlo Trombetta, MD; Email: trombcar@units.it
    • Principal Investigator: Carlo Trombetta, MD
  • Udine, Italy
    • Not yet recruiting
    • Presidio Ospedaliero Universitario Santa Maria della Misericorida (ASU FC)
    • Contact: Gianluca Giannarini, MD; Email: gianluca.giannarini@asufc.sanita.fvg.it
    • Principal Investigator: Gianluca Giannarini, MD
  • Verona, Italy
    • Recruiting
    • Azienda Ospedaliera Universitaria Integrata - Verona
    • Contact: Alessandro Antonelli, MD; Phone Number: +39 0458127702/03; Email: alessandro.antonelli@aovr.veneto.it
    • Principal Investigator: Alessandro Antonelli, MD
  • Bolzano
    • Bressanone, Bolzano, Italy
      • Not yet recruiting
      • Ospedale di Bressanone
      • Contact: Michael Aigner, MD; Email: michael.aigner@sabes.it
      • Principal Investigator: Michael Aigner, MD
  • Padova
    • Abano Terme, Padova, Italy
      • Recruiting
      • Casa di Cura Abano Terme
      • Contact: Daniele Romagnoli, MD; Email: dromagnolo@casacura.it
      • Principal Investigator: Daniele Romagnoli, MD
  • Venezia
    • Dolo, Venezia, Italy
      • Recruiting
      • Ospedale di Dolo
      • Contact: Gianna Pace, MD; Email: gianna.pace@aulss3.veneto.it
      • Principal Investigator: Gianna Pace, MD
  • Vicenza
    • Bassano Del Grappa, Vicenza, Italy
      • Recruiting
      • Ospedale di Bassano del Grappa
      • Contact: Antonio Celia, MD; Email: antonio.celia@aulss7.veneto.it
      • Principal Investigator: Antonio Celia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with a diagnosis of new-onset oligo-metastatic prostatic neoplasia are included in the study. The definition of oligo-metastatic neoplasm is based on the CHARTEED criteria (less than 4 metastases, absence of visceral metastases).

All patients should undergo staging by conventional imaging techniques (total body bone scintigraphy, CT abdomen with mdc) or with PET-CT (choline or PSMA) and multiparametric prostate MRI to assess the local extension (clinical stage) of the disease, surgical resectability of the disease and radiotherapy planning.

In addition, individual cases should be discussed in the multidisciplinary oncology group of the enrolling centre. The choice of treatment type will be based on the decision of the multidisciplinary team and the patient's preferences.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Single arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
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
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
Quality of life assessment	Assessment of QoL using the EPIC-26 Short Form questionnaire.	From admission to discharge, assessed up to 3 years
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

Collaborators and Investigators

• Sponsor: Istituto Oncologico Veneto IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Estimated): February 22, 2024

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Neoplasms; Prostatic Neoplasms
• Other Study ID Numbers: IOV-PR-1-2022-OLIGOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No