Prostate CarcinomaPRODARTNCT06822491

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

An observational study of Prostate Carcinoma and Localized Prostate Adenocarcinoma, run by University of Zurich at 1 site in Switzerland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Carcinoma, Localized Prostate Adenocarcinoma, Stereotactic Body Radiotherapy
How many people: 28 participants
Where: 1 siteSwitzerland
Study dates: 20 Aug 2024to Jun 2031
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Study population: Patients referred to our tertiary referral centre for prostate cancer

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

University Hospital Zurich
Zurich, 8091

Other trials in Switzerland

About this study

Official title: 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)

Read the detailed description

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: Prostate Carcinoma, Localized Prostate Adenocarcinoma, Stereotactic Body Radiotherapy, Stereotactic Radiotherapy, Magnetic Resonance Imaging, Multiparametric MRI
Keywords: DIL, Dominant intraprostatic lesion
Medical subject headings: Prostatic Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 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
To correlate late prostate-specific antigen response with early multiparametric magnetic resonance imaging changes of the PIRADS ≥3 lesion(s) correlating with Gleason ≥7a pathology
Measured: Yearly (up to 5 years post SBRT)
Correlation of genitourinary and gastrointestinal toxicity with early multiparametric magnetic resonance imaging changes
Correlating genitourinary and/or gastrointestinal toxicity (according to common terminology criteria for adverse events [CTCAE] version 5.0) with structural and/or functional changes of the prostate and/or surrounding organs on early multiparametric magnetic resonance imaging
Measured: 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
Quality of life (according to EPIC-26) and relation to early structural and/or functional changes of the prostate and/or surrounding organs on multiparametric magnetic resonance imaging
Measured: 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.
To evaluate prostate volume change intra-treatment and after adaptive prostate SBRT and to correlate to treatment toxicity.
Measured: 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
Quantitative imaging features will be used to predict outcome and side effects on the different images.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Aug 2024Jun 2031

First posted12 Feb 2025
Study start20 Aug 2024
Primary completionJun 2026 (estimated)
Study completionJun 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
More trials run by University of ZurichThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 28 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06822491
Sponsor's protocol ID: RAO-24-005
Acronym: PRODART
Status last verified: Dec 2025
First submitted: 6 Feb 2025
Last updated: 23 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data that underlie the results reported in this trial after de-identification. Other documents may be shared include the study protocol.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT06822491
Acronym / sponsor ID: PRODART / RAO-24-005
Conditions: Prostate Carcinoma, Localized Prostate Adenocarcinoma, Stereotactic Body Radiotherapy, Stereotactic Radiotherapy, Magnetic Resonance Imaging, Multiparametric MRI
Keywords: DIL, Dominant intraprostatic lesion
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 28 participants (estimated)
Lead sponsor: University of ZurichUniversity, hospital or other
Study start: 20 Aug 2024 (actual)
Primary completion: Jun 2026 (estimated)
Study completion: Jun 2031 (estimated)
First posted: 12 Feb 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients referred to our tertiary referral centre for prostate cancer

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Multiparametric magnetic resonance imaging local control of the dominant intraprostatic lesion
Time frame: 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 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.
Correlation of early prostate-specific antigen response with early multiparametric magnetic resonance imaging changes
Time frame: 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 correlate early prostate-specific antigen response with early multiparametric magnetic resonance imaging changes of the PIRADS ≥3 lesion(s) correlating with Gleason ≥7a pathology

5 secondary outcomes

Correlation of late prostate-specific antigen response with early multiparametric magnetic resonance imaging changes
Time frame: Yearly (up to 5 years post SBRT)
Correlation of genitourinary and gastrointestinal toxicity with early multiparametric magnetic resonance imaging changes
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this trial after de-identification. Other documents may be shared include the study protocol.

Related trials for Prostate Carcinoma

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Matthias Guckenberger, Prof. Dr. med. principal investigator

University of Zurich

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Carcinoma and Localized Prostate Adenocarcinoma, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Multiparametric magnetic resonance imaging local control of the dominant intraprostatic lesion (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06822491.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.