Oligometastatic Prostate Carcinoma
Conditions
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.
Interventions
None listed
Sponsors
Istituto Oncologico Veneto IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Cancer-specific survival | 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. |
| CRPCa development | 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 |
| Radiological progression-free survival | 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). |
| Quality of life assessment | From admission to discharge, assessed up to 3 years | Assessment of QoL using the EuroQol 5-dimensional 5-level questionnaire (EQ-5D-5L)19 |
| Complications | 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 |
Countries
Italy
Contacts
Primary ContactAngelo Porreca, MD
Backup ContactGian Luca De Salvo, MD
Outcome results
None listed