Impact of treatment on prostate cancer with limited metastasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicentre prospective observational study aims to create a registry of patients with newly diagnosed oligometastatic prostate carcinoma, following CHAARTED criteria. It will evaluate the oncological outcomes and quality of life impacts of local treatment (surgery or radiotherapy) combined with systemic hormonal therapy. The study focuses on patients with low-volume metastatic disease, ensuring they do not have high metastatic volume characteristics. Data will be collected from major urological centers in the Triveneto region.

Why it matters

Who can join: the full rules

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)

Where it's running

• Casa di Cura Abano Terme
  Abano Terme, Padova, Italy Recruiting
• Ospedale di Dolo
  Dolo, Venezia, Italy Recruiting
• Ospedale di Bassano Del Grappa
  Bassano del Grappa, Vicenza, Italy Recruiting
• Ospedale dell'Angelo - Mestre
  Mestre, Italy Recruiting
• Istituto Oncologico Veneto IRCCS
  Padova, Italy Recruiting
• Ospedali Riuniti Padova Sud
  Padova, Italy Recruiting

Study contacts

• Study coordinator: Angelo Porreca, MD
• Email: angelo.porreca@iov.veneto.it
• Phone: 0423 421321

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tailored survivorship care plans to improve health literacy after prostate cancer

  This will test whether a survivorship care plan designed for people with low health literacy helps Black or African American men who finished treatment for localized or oligometastatic prostate cancer better understand and access follow-up care than a standard plan.

  Recruiting at 3 sites Emory University · Atlanta, Georgia and 2 other locations · NCT06674863

• Using advanced imaging to predict lymph node spread in high-risk prostate cancer

  This study is testing a new imaging method to see if it can help doctors predict whether high-risk prostate cancer has spread to lymph nodes before surgery.

  Recruiting Mayo Clinic · Jacksonville, Florida · NCT06389786

• Prostate Radiotherapy and Metastasis-Directed Therapy in Synchronous Oligometastatic Prostate Cancer

  This registry follows men with new, limited metastatic prostate cancer who receive targeted radiotherapy to the prostate and all visible metastases to see how they do over time in real-world care.

  Recruiting Affidea Nu-med Center of Oncological DIagnostics and Therapy · Zamość, Lublin Voivodeship · NCT07686016

• Comprehensive radiotherapy to all metastases plus primary prostate radiotherapy versus prostate-only radiotherapy for men with oligometastatic prostate cancer

  This tests whether adding radiation to all PSMA-PET-visible metastases along with standard systemic therapy helps men with newly diagnosed oligometastatic prostate cancer stay progression-free longer than treating the prostate alone.

  Recruiting Peking University First Hospital · Beijing, Beijing Municipality and 2 other locations · NCT07015138

• Maximal tumor eradication for patients with oligometastatic prostate cancer

  This study is testing a new combination treatment for men with oligometastatic prostate cancer to see if it can improve their survival and quality of life.

  Recruiting Phase 2/3 RenJi Hospital · Shanghai · NCT06972511

• Genomic biomarker-guided therapy for advanced prostate cancer

  This study is testing if personalized treatment based on genetic markers can help men with advanced prostate cancer before surgery.

  Recruiting Phase 2 The First Affiliated Hospital of Xiamen University · Xiamen, Fujian · NCT06387056

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.