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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-20

Study Completion Date

2031-06-30

Brief Summary

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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.

Detailed Description

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Background: Stereotactic body radiotherapy (SBRT) is an established standard of care treatment for localized prostate cancer. Recent pathological studies suggest the presence of a dominant intraprostatic lesion (DIL) within the prostate, which serve as a central driver of tumor aggressiveness and recurrence after treatment. Prostate-specific antigen (PSA) monitoring is the cornerstone of follow-up, though time to PSA nadir after SBRT can extend to 3 years.

Methods: This phase II observational study aims to evaluate the correlation between PSA response and early multiparametric magnetic resonance imaging (mpMRI) changes of the DIL(s) at 6- or 9-months following online adaptive SBRT for intermediate to (very) high risk localized prostate cancer. The primary outcome is the achievement of local control as assessed by mpMRI at 6 months post-SBRT or, if necessary, at 9 months post-SBRT (in case of image non complete response at 6 months). A complete imaging response is defined as the disappearance of all morphological and functional mpMRI changes of PIRADS (Prostate Imaging Reporting and Data System) ≥3 lesion(s) correlating with Gleason ≥7a pathology. No confirmatory biopsies will be conducted. The required sample size for this study will be 28 patients, assuming a complete response rate of 80% at 6 months, targeting an acceptable margin of error with 95% confidence, and a margin of error of 15%.

Conditions

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

Keywords

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DIL Dominant intraprostatic lesion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthias Guckenberger, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

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University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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RAO-24-005

Identifier Type: -

Identifier Source: org_study_id