Trial Title:
OLIGOS: Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate
NCT ID:
NCT06273345
Condition:
Oligometastatic Prostate Carcinoma
Conditions: Official terms:
Neoplasms
Prostatic Neoplasms
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
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)
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Ospedale di Bressanone
Address:
City:
Bressanone
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Michael Aigner, MD
Email:
michael.aigner@sabes.it
Investigator:
Last name:
Michael Aigner, MD
Email:
Principal Investigator
Facility:
Name:
Casa di Cura Abano Terme
Address:
City:
Abano Terme
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Daniele Romagnoli, MD
Email:
dromagnolo@casacura.it
Investigator:
Last name:
Daniele Romagnoli, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale di Dolo
Address:
City:
Dolo
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Gianna Pace, MD
Email:
gianna.pace@aulss3.veneto.it
Investigator:
Last name:
Gianna Pace, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale di Bassano Del Grappa
Address:
City:
Bassano Del Grappa
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Antonio Celia, MD
Email:
antonio.celia@aulss7.veneto.it
Investigator:
Last name:
Antonio Celia, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale dell'Angelo - Mestre
Address:
City:
Mestre
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Francesco Gerardo Mandato, MD
Email:
francesco.mandato@aulss3.veneto.it
Investigator:
Last name:
Francesco Gerardo Mandato, MD
Email:
Principal Investigator
Facility:
Name:
Istituto Oncologico Veneto IRCCS
Address:
City:
Padova
Zip:
35128
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Angelo Porreca, MD
Phone:
0423 421321
Phone ext:
+39
Email:
angelo.porreca@iov.veneto.it
Contact backup:
Last name:
Gian Luca De Salvo, MD
Phone:
049 8215710
Phone ext:
+39
Email:
gianluca.desalvo@iov.veneto.it
Investigator:
Last name:
Angelo Porreca, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedale Università Padova
Address:
City:
Padova
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Fabio Zattoni, MD
Email:
fabio.zattoni@unipd.it
Investigator:
Last name:
Fabio Zattoni, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale MAter Salutis - Legnago
Address:
City:
Padova
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Pierpaolo Curti, MD
Phone:
0442 622387
Phone ext:
+39
Email:
pierpaolo.curti@aulss9.veneto.it
Investigator:
Last name:
Pierpaolo Curti, MD
Email:
Principal Investigator
Facility:
Name:
Ospedali Riuniti Padova Sud
Address:
City:
Padova
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Nicola Zanovello, MD
Email:
nicola.zanovello@aulss6.veneto.it
Investigator:
Last name:
Nicola Zanovello, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
Address:
City:
Trieste
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Carlo Trombetta, MD
Email:
trombcar@units.it
Investigator:
Last name:
Carlo Trombetta, MD
Email:
Principal Investigator
Facility:
Name:
Presidio Ospedaliero Universitario Santa Maria della Misericorida (ASU FC)
Address:
City:
Udine
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Gianluca Giannarini, MD
Email:
gianluca.giannarini@asufc.sanita.fvg.it
Investigator:
Last name:
Gianluca Giannarini, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera Universitaria Integrata - Verona
Address:
City:
Verona
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Alessandro Antonelli, MD
Phone:
0458127702/03
Phone ext:
+39
Email:
alessandro.antonelli@aovr.veneto.it
Investigator:
Last name:
Alessandro Antonelli, MD
Email:
Principal Investigator
Start date:
January 23, 2023
Completion date:
January 2025
Lead sponsor:
Agency:
Istituto Oncologico Veneto IRCCS
Agency class:
Other
Source:
Istituto Oncologico Veneto IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06273345
