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NCT Number: NCT06397755

Observational Study of Patients Who Underwent Diagnostic Investigation (Prostate Biopsy) and/or Radical Prostatectomy Surgery.

This is a single-center, observational, prospective and retrospective study on quality of life and disease status of patients who underwent prostate biopsy and/or radical prostatectomy.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

About this study

A database was created with the intention of collecting data related to patients who underwent prostate biopsy and/or radical prostatectomy.

Only anamnesis and biopsy procedure data are collected for patients underwent prostate biopsy.

Anamnesis, surgery, histological report and hospitalization data are collected for patients who underwent radical prostatectomy.

Each patient will be followed for 50 years from the date of radical prostatectomy surgery.

Each patient will receive a questionnaire before radical prostatectomy. A follow up questionnaire will be collected after surgery relating to quality of life. The data for each patient will then be transferred to the database itself. The data collected will be handled following the most strict GCPs and privacy norms.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with a suspicious prostate disease who underwent prostate biopsy and/or radical prostatectomy;
  • Adult patients > 18 years
  • Ability to read and sign the informed consent

Exclusion criteria

  • Patients < 18 years
  • mental or physical disability that may prevent the patient from satisfying the requirements of the protocol
  • Inability to read and sign the informed consent

Treatment and study plan

Prostate Biopsy and/or Radical Prostatectomy

Procedure

Prostate Biopsy: procedure to remove samples of suspicious tissue from the prostate Radical Prostatectomy: surgery to remove the prostate gland and seminal vesicles (and sometimes nearby lymph nodes) after a prostate cancer diagnosis

Primary outcomes

  1. Clinically significant Prostate Cancer

    Time frame: 1 month

    Diagnosis of clinically significant PCa at prostate biopsy

  2. Overall survival

    Time frame: every 6 month after surgery up to 50 years after surgery

    Death by any cause

  3. Cancer-specific mortality

    Time frame: every 6 month after surgery up to 50 years after surgery

    Death from prostate cancer

  4. Biochemical recurrence

    Time frame: every 6 month after surgery up to 50 years after surgery

    PSA >= 0.2 ng/ml in 2 consecutive measures

Secondary outcomes

  1. Erectile function

    Time frame: every 6 month after surgery up to 50 years after surgery

    IIEF-EF >=21

  2. Urinary continence

    Time frame: every 6 month after surgery up to 50 years after surgery

    No pads over a 24 hour period

Study contacts

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

Andrea Salonia

CONTACT

[email protected]

+39 0226435661

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Important dates

Study start
2015
Primary completion
2065
Study completion
2065
First posted
May 3, 2024
Registry last updated
May 3, 2024

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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