Phase 3 Prostate Cancer Trial, Recruiting NCT06717711 Sponsor: Regina Elena Cancer Institute Condition: Prostate Cancer
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Phase 3 Prostate Cancer Trial, Recruiting

NCT06717711
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 to 75 years old
  • People whose PSA blood test result is below 10 ng/mL before surgery
  • People whose prostate cancer has been graded as ISUP grade 2 or lower, and has not spread beyond the prostate (stage cT2 or lower), based on a biopsy
  • People who are having a type of keyhole robotic prostate removal surgery where the surgeon takes care to preserve the nerves around the prostate
  • People whose score on a sexual function questionnaire (called the IIEF-5) is 17 or higher before surgery
  • People whose first PSA blood test result after surgery (taken around 45 days later) is below 0.1
  • People whose final tissue results after surgery confirm the cancer is ISUP grade 2 or lower and has not spread to a certain extent (pT stage below 3b)
  • People who are willing and able to follow the study requirements, including completing questionnaires about sexual function and quality of life
  • People who are able to provide written consent to take part in the trial

Who may not be able to join:

  • People for whom robotic surgery is not safe due to anaesthesia-related health concerns
  • People who have previously had radiotherapy to the pelvis or hormone treatment to lower testosterone (androgen deprivation therapy)
  • People who experience serious complications after surgery (graded as Clavien-Dindo grade 3 or higher — confirm with trial site)
  • People for whom a group of medications used to treat erectile difficulties (called PDE5 inhibitors) would not be safe due to heart or blood vessel health concerns

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 0652665005

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Regina Elena Cancer Institute
Registry
ClinicalTrials.gov
Start date
31 August 2024
Est. completion
31 August 2025

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Erectile Function

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov