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

NCT06822491 | Active Not Recruiting

• 1 other identifier: RAO-24-005
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Carcinoma; Localized Prostate Adenocarcinoma; Stereotactic Body Radiotherapy; Stereotactic Radiotherapy; Magnetic Resonance Imaging; Multiparametric MRI

Keywords

DIL; Dominant intraprostatic lesion

Outcome Measures

Primary Outcomes (2)

• Multiparametric magnetic resonance imaging local control of the dominant intraprostatic lesion

  To study multiparametric magnetic resonance imaging (mpMRI) local control of Prostate Imaging Reporting and Data System (PIRADS) ≥3 lesion(s) after SBRT. An image complete response is defined as disappearance of all morphological and functional PIRADS ≥3 lesion(s) correlating with Gleason ≥7a pathology in mpMRI.

  6 months after SBRT. In cases with image non-complete response at 6 months, 3 months later (in total 9 months after SBRT) an additional mpMRI will be performed.

• Correlation of early prostate-specific antigen response with early multiparametric magnetic resonance imaging changes

  To correlate early prostate-specific antigen response with early multiparametric magnetic resonance imaging changes of the PIRADS ≥3 lesion(s) correlating with Gleason ≥7a pathology

  6 months after SBRT. In cases with image non-complete response at 6 months, 3 months later (in total 9 months after SBRT) an additional mpMRI will be performed.

Secondary Outcomes (5)

• Correlation of late prostate-specific antigen response with early multiparametric magnetic resonance imaging changes

  Yearly (up to 5 years post SBRT)

• Correlation of genitourinary and gastrointestinal toxicity with early multiparametric magnetic resonance imaging changes

  6 months after SBRT. In cases with image non-complete response at 6 months, 3 months later (in total 9 months after SBRT) an additional mpMRI will be performed.

• Correlation of prostate quality of life with early multiparametric magnetic resonance imaging changes

  6 months after SBRT. In cases with image non-complete response at 6 months, 3 months later (in total 9 months after SBRT) an additional mpMRI will be performed.

• To evaluate prostate volume change during and after adaptive prostate SBRT and to correlate to treatment toxicity.

  Intra-treatment (within 1 week before the last fraction of SBRT) and 6 months after SBRT. In cases with image non-complete response at 6 months, 3 months later (in total 9 months after SBRT) an additional mpMRI will be performed.

• Exploratory image analysis

  6 months after SBRT. In cases with image non-complete response at 6 months, 3 months later (in total 9 months after SBRT) an additional mpMRI will be performed.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to our tertiary referral centre for prostate cancer

You may qualify if:

• 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

You may not qualify if:

• Previous (≤10 years) local therapy of the prostate including transurethral resection of the prostate (TURP),
• Contraindication for MRI;
• Previous (≤10 years) radiotherapy in the pelvis;
• Lymph node metastases or distant metastases (i.e. no localized prostate cancer);
• Participation in a clinical trial which might influence the results of this project;
• Claustrophobic anxiety;
• Uncontrolled intercurrent illness;
• Relation to investigator (family or professional)

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Matthias Guckenberger, Prof. Dr. med.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 12, 2025
• Study Start: August 20, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2031
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months after article publication.
• Access Criteria: Proposals to access study data should send request to matthias.guckenberger@usz.ch. To gain access, data requesters must sign data access agreement.

Locations

CH (1)