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NCT06822491Active, not recruiting

Early Magnetic Resonance Imaging Response of the Dominant Intraprostatic Lesion After Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer and Correlation With Prostate Specific Antigen Response

Early Magnetic Resonance Imaging Response of the Dominant Intraprostatic Lesion After Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer and Correlation With Prostate Specific Antigen Response (PRODART)

Source: ClinicalTrials.gov · Last updated 23 Dec 2025

Brief summary (registry, in English)

The aim of this phase II study is to determine the early multiparametric magnetic resonance imaging response of the dominant intraprostatic lesion and correlate these findings with prostate specific antigen response in patients with intermediate to (very) high risk localized prostate cancer treated with online adaptive stereotactic radiotherapy without intraprostatic fiducial markers.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
28 (estimated)
First submitted
6 Feb 2025
Start date
20 Aug 2024
Primary completion date
Jun 2026
Lead sponsor
University of Zurich
NCT number
NCT06822491

What you commit to

  • Study type: Observational
  • Planned participants: 28
  • From 20 Aug 2024 to the primary completion date, Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous (≤10 years) local therapy of the prostate including transurethral resection of the prostate (TURP),
  • Previous (≤10 years) radiotherapy in the pelvis;

Other illness

  • Lymph node metastases or distant metastases (i.e. no localized prostate cancer);
  • Uncontrolled intercurrent illness;

Other

  • Contraindication for MRI;
  • Participation in a clinical trial which might influence the results of this project;
  • Claustrophobic anxiety;
  • Relation to investigator (family or professional)

Who the study is looking for

  • Patients with histologically confirmed localized prostate cancer who are planned for CT- or MRI-adaptive SBRT for prostate cancer;
  • Presence of PIRADS ≥3 lesion(s) in a mpMRI correlating with Gleason ≥7 score at diagnosis;
  • Intermediate to (very) high risk localized prostate cancer (≤ cT3b and cN0);
  • ECOG performance status of 0-2;
  • Age ≥ 18 years;
  • PSMA PET ≤3 months is compulsory for high-risk prostate cancer (as part of clinical routine);
  • Written informed consent.
  • Willingness and ability to comply with schedule

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital Zurich
Coordinator of this site? Confirm its status
ZurichSwitzerlandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.