Oligometastatic Prostate CarcinomaOLIGOSNCT06273345
OLIGOS: Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate
An observational study of Oligometastatic Prostate Carcinoma, run by Istituto Oncologico Veneto IRCCS at 12 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Oligometastatic Prostate Carcinoma
- How many people
- 150 participants
- Where
- 12 sitesItaly
- Study dates
- 23 Jan 2023to Jan 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Italy12 sites, 12 recruiting
- Recruiting
Casa di Cura Abano Terme
Abano Terme, Padova
Daniele Romagnoli, MD, dromagnolo@casacura.it
Daniele Romagnoli, MD
- Recruiting
Ospedale di Bassano Del Grappa
Bassano del Grappa, Vicenza
Antonio Celia, MD, antonio.celia@aulss7.veneto.it
Antonio Celia, MD
- Not yet recruiting
Ospedale di Bressanone
Brixen, Bolzano
Michael Aigner, MD, michael.aigner@sabes.it
Michael Aigner, MD
- Recruiting
Ospedale di Dolo
Dolo, Venezia
Gianna Pace, MD, gianna.pace@aulss3.veneto.it
Gianna Pace, MD
- Recruiting
Ospedale dell'Angelo - Mestre
Mestre
Francesco Gerardo Mandato, MD, francesco.mandato@aulss3.veneto.it
Francesco Gerardo Mandato, MD
- Recruiting
Istituto Oncologico Veneto IRCCS
Padova, 35128
Angelo Porreca, MD, 0423 421321 ext. +39, angelo.porreca@iov.veneto.it
Gian Luca De Salvo, MD, 049 8215710 ext. +39, gianluca.desalvo@iov.veneto.it
- Not yet recruiting
Azienda Ospedale Università Padova
Padova
Fabio Zattoni, MD, fabio.zattoni@unipd.it
Fabio Zattoni, MD
- Not yet recruiting
Ospedale MAter Salutis - Legnago
Padova
Pierpaolo Curti, MD, 0442 622387 ext. +39, pierpaolo.curti@aulss9.veneto.it
Pierpaolo Curti, MD
- Recruiting
Ospedali Riuniti Padova Sud
Padova
Nicola Zanovello, MD, nicola.zanovello@aulss6.veneto.it
Nicola Zanovello, MD
- Not yet recruiting
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
Trieste
Carlo Trombetta, MD, trombcar@units.it
Carlo Trombetta, MD
- Not yet recruiting
Presidio Ospedaliero Universitario Santa Maria della Misericorida (ASU FC)
Udine
Gianluca Giannarini, MD, gianluca.giannarini@asufc.sanita.fvg.it
Gianluca Giannarini, MD
- Recruiting
Azienda Ospedaliera Universitaria Integrata - Verona
Verona
Alessandro Antonelli, MD, 0458127702/03 ext. +39, alessandro.antonelli@aovr.veneto.it
Alessandro Antonelli, MD
About this study
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)).
Read more
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.
- Conditions
- Oligometastatic Prostate Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (6)
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.
Measured: 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
Measured: 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).
Measured: 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
Measured: From admission to discharge, assessed up to 3 years
Quality of life assessment
Assessment of QoL using the EPIC-26 Short Form questionnaire.
Measured: 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
Measured: From admission to discharge, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start23 Jan 2023
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oligometastatic Prostate CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Istituto Oncologico Veneto IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273345
- Sponsor's protocol ID
- IOV-PR-1-2022-OLIGOS
- Acronym
- OLIGOS
- Status last verified
- Apr 2025
- First submitted
- 6 Feb 2024
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OLIGOS: Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate
- ClinicalTrials.gov ID
- NCT06273345
- Acronym / sponsor ID
- OLIGOS / IOV-PR-1-2022-OLIGOS
- Conditions
- Oligometastatic Prostate Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Istituto Oncologico Veneto IRCCSUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival (OS)
Time frame: from the start date of the chosen treatment to the date of the subject's death from any cause, up to 3 years
Impact of primary tumour treatment in addition to systemic therapy on overall survival (OS) in patients with new-onset oligometastatic prostate neoplasia.
6 secondary outcomes
Cancer-specific survival
Time frame: from the start date of the chosen treatment to the subject's death caused by the malignancy, up to 3 years.
CRPCa development
Time frame: From the date of randomization up to 3 years
Radiological progression-free survival
Time frame: From the treatment start date to radiological progression, up to 3 years
Quality of life assessment
Time frame: From admission to discharge, assessed up to 3 years
Quality of life assessment
Time frame: From admission to discharge, assessed up to 3 years
Complications
Time frame: From admission to discharge, assessed up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oligometastatic Prostate Carcinoma, run by Istituto Oncologico Veneto IRCCS at 12 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angelo Porreca, MD (0423 421321 ext. +39, angelo.porreca@iov.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: from the start date of the chosen treatment to the date of the subject's death from any cause, up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.