Prostate Cancer Trial, Recruiting NCT05936736 Sponsor: IRCCS San Raffaele Condition: Prostate Cancer
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Prostate Cancer Trial, Recruiting

NCT05936736
Recruiting Not Applicable

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 who have been diagnosed with prostate cancer (a type called adenocarcinoma), confirmed by a tissue biopsy, across a range of grades from low to high
  • People who are over 18 years of age
  • People who have signed a consent form agreeing to take part in the trial
  • People whose lymph nodes have been confirmed as cancer-free by imaging scans (such as a PSMA PET/CT and/or pelvic MRI) within the past 3 months, where guidelines recommend this check
  • People whose cancer has been confirmed as not having spread to distant parts of the body, based on appropriate scans within the past 3 months, where guidelines recommend this check
  • People with acceptable bladder flow test results — specifically, a peak urine flow ideally at or above 15 ml per second and a low amount of urine left in the bladder after urinating (50 ml or less); people with slightly lower flow rates may still be considered if a short course of hormone therapy improves results to at least 12 ml per second
  • People with a general health status rated as reasonably functional (confirm with trial site for exact rating)
  • People who have not previously had radiotherapy to the pelvis
  • People who are able to complete quality-of-life questionnaires about urinary, sexual, and general health (confirm with trial site for specific forms required)

Who may not be able to join:

  • People with serious conditions affecting other major body systems
  • People with psychological or other conditions that would prevent them from being able to sign a consent form
  • People who have had another invasive cancer in the past, unless it was a non-melanoma skin cancer, or unless they have been free of any cancer for at least 3 years (certain early-stage cancers such as carcinoma in situ may still be considered — confirm with trial site)
  • People whose cancer has spread to the lymph nodes
  • People whose cancer has spread to distant parts of the body
  • People who score more than 20 points on a urinary symptom questionnaire (called the IPSS)
  • People whose bladder flow test shows a maximum flow rate at or below 11 ml per second and/or more than 100 ml of urine remaining in the bladder after urinating
  • People with ongoing inflammatory conditions of the urinary or digestive system, such as ulcerative colitis or Crohn's disease
  • People with an overactive bladder
  • People for whom small marker implants (called fiducials) cannot be placed in the prostate
  • People who are unable or unwilling to have a bladder catheter inserted for planning scans
  • People who are unable to have an MRI scan for treatment planning
  • People for whom hormone therapy would not be medically appropriate, if their cancer risk level requires it
  • People whose cancer or anatomy means that safe radiation dose limits cannot be met within the treatment plan

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
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Nadia Di Muzio, Prof, IRCCS San Raffaele Scientific Institute

Phone: +390226437634

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
Not Applicable
Sponsor
IRCCS San Raffaele
Registry
ClinicalTrials.gov
Start date
8 November 2023
Est. completion
1 May 2028

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Acute toxicity

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