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NCT Number: NCT06273345

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

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.

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Key information

Conditions

Oligometastatic Prostate Carcinoma

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Ospedale di Bressanone, Brixen, Bolzano, Italy

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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.

  2. CRPCa development

    Time frame: From the date of randomization up to 3 years

    Serum testosterone levels < 50 ng/dL or 1.7 nmol/L in association with biochemical progression or radiological progression

  3. Radiological progression-free survival

    Time frame: From the treatment start date to radiological progression, up to 3 years

    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).

  4. Quality of life assessment

    Time frame: From admission to discharge, assessed up to 3 years

    Assessment of QoL using the EuroQol 5-dimensional 5-level questionnaire (EQ-5D-5L)19

  5. Quality of life assessment

    Time frame: From admission to discharge, assessed up to 3 years

    Assessment of QoL using the EPIC-26 Short Form questionnaire.

  6. Complications

    Time frame: From admission to discharge, assessed up to 3 years

    Evaluation of complications related to radiotherapy treatment, according to CTCAE v5.0 and surgical treatment, evaluated according to the Clavien Dindo classification

Study contacts

Contact information is provided by the study sponsor or research team.

Angelo Porreca, MD

CONTACT

[email protected]

0423 421321 ext. +39

Gian Luca De Salvo, MD

CONTACT

[email protected]

049 8215710 ext. +39

Sponsors and collaborators

Lead sponsor

Istituto Oncologico Veneto IRCCS

Other

Registry information

Acronym: OLIGOS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 22, 2024
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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