Active — Not RecruitingNot Applicable

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

Switzerland28 participantsStarted 2024-08-20

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Multiparametric magnetic resonance imaging local control of the dominant intraprostatic lesion

Timeframe: 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

Timeframe: 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.

Trial details

NCT IDNCT06822491

SponsorUniversity of Zurich

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06

View on ClinicalTrials.gov More Prostate Carcinoma trials

Plain-language summary

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Multiparametric magnetic resonance imaging local control of the dominant intraprostatic lesion

Timeframe: 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

Timeframe: 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.