Clinical trial NCT06273345: OLIGOS: Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate
Official title: OLIGOS: Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oligometastatic Prostate Carcinoma
Lead sponsor: Istituto Oncologico Veneto IRCCS
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Overall survival (OS)
timeFrame: from the start date of the chosen treatment to the date of the subject's death from any cause, up to 3 years
Secondary outcomes:
measure: Cancer-specific survival
timeFrame: from the start date of the chosen treatment to the subject's death caused by the malignancy, up to 3 years.
measure: CRPCa development
timeFrame: From the date of randomization up to 3 years
measure: Radiological progression-free survival
timeFrame: From the treatment start date to radiological progression, up to 3 years
measure: Quality of life assessment
timeFrame: From admission to discharge, assessed up to 3 years
measure: Quality of life assessment
timeFrame: From admission to discharge, assessed up to 3 years
measure: Complications
timeFrame: From admission to discharge, assessed up to 3 years
Other outcomes:
Locations:
city: Bressanone
country: Italy
facility: Ospedale di Bressanone
state: Bolzano
city: Abano Terme
country: Italy
facility: Casa di Cura Abano Terme
state: Padova
city: Dolo
country: Italy
facility: Ospedale di Dolo
state: Venezia
city: Bassano Del Grappa
country: Italy
facility: Ospedale di Bassano Del Grappa
state: Vicenza
city: Mestre
country: Italy
facility: Ospedale dell'Angelo - Mestre
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IRCCS
city: Padova
country: Italy
facility: Azienda Ospedale Università Padova
city: Padova
country: Italy
facility: Ospedale MAter Salutis - Legnago
city: Padova
country: Italy
facility: Ospedali Riuniti Padova Sud
city: Trieste
country: Italy
facility: Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
city: Udine
country: Italy
facility: Presidio Ospedaliero Universitario Santa Maria della Misericorida (ASU FC)
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata - Verona
Study officials:
References: