Identifying risks in low-risk prostate cancer patients on active surveillance

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 study focuses on patients diagnosed with low-risk prostate cancer who are eligible for active surveillance. It aims to identify those at higher risk of disease progression by utilizing advanced imaging techniques, such as PSMA PET scans, and molecular analysis through whole exome sequencing and immunohistochemistry. Participants will undergo a confirmatory biopsy one year after diagnosis to assess the predictive accuracy of a multivariable model that integrates these advanced biomarkers. The goal is to improve risk stratification for better management of prostate cancer.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically proven low-risk PCa (PSA ≤10 ng/ml; clinical stage ≤T2a, and biopsy ISUP GG 1)
* Non-metastatic status at study inclusion (patient enrollment).
* No prior or concomitant androgen deprivation therapy
* Ability to understand a written informed consent and willingness to sign it.

Exclusion Criteria:

* Unable to tolerate a PSMA-PET scan
* Unwillingness to be managed with AS
* Receipt of neoadjuvant or curative-intent therapies
* Pacemaker
* Inability to obtain the FFPE prostate biopsy specimens from the initial biopsy

Where it's running

• IRCCS Ospedale San Raffaele
  Milan, Italy, Italy Recruiting

Study contacts

• Study coordinator: Giorgio Gandaglia
• Email: gandaglia.giorgio@hsr.it
• Phone: +39 0226438068

Similar studies

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

• Using PSMA PET/CT imaging to help choose which men with low-risk prostate cancer can enter active surveillance

  The team will test whether delayed Ga-68 PSMA PET/CT scans using the Istanbul PSMA PET/CT Criteria can help decide which men with biopsy-confirmed low-risk prostate cancer can safely choose active surveillance.

  Recruiting at 10 sites Istanbul University - Cerrahpasa · Istanbul, Turkey and 9 other locations · NCT07168616

• Reducing prostate cancer treatment from 5 to 3 doses of radiotherapy

  This study is testing whether giving fewer doses of radiotherapy for early prostate cancer can still be just as effective and have fewer side effects for patients.

  Recruiting NHS Lothian · Edinburgh · NCT06117059

• Liquid biopsy biomarkers to detect and monitor pancreatic cancer

  Researchers test blood-based microRNA signals to see if they can identify pancreatic cancer risk or early disease in people with familial or hereditary risk or mucinous cysts.

  Recruiting Università Vita-Salute San Raffaele · Milan, MI · NCT07700992

• Adherence to Guideline-Directed Medical Therapy in Advanced Heart Failure

  This study tests how closely people with advanced heart failure follow the standard four-drug regimen in real-world care.

  Recruiting Università Vita-Salute San Raffaele · Bergamo and 1 other locations · NCT07560982

• Natural history and biomarker mapping for LAMA2-related dystrophy

  It will track how LAMA2-related dystrophy changes over time in children and adults and look for biological markers that match disease features.

  Recruiting Università Vita-Salute San Raffaele · Milan · NCT07125040

• Adding ketamine to ECT for treatment-resistant depression

  This trial will test whether giving IV ketamine during ECT helps adults with treatment-resistant major depression get better faster and have fewer thinking problems.

  Recruiting Phase 3 Università Vita-Salute San Raffaele · Milan · NCT07088380

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.