Standard Moderately Hypofractionated RT vs. Ultra-hypofractionated Focal Lesion Ablative Microboost in Prostate Cancer

Launched by THE NETHERLANDS CANCER INSTITUTE · Jan 30, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different types of radiation therapy for men with prostate cancer. It compares the standard treatment, which involves giving radiation in 20 sessions (called moderately hypofractionated radiotherapy), to a newer approach that uses fewer sessions (only 5) but delivers a higher dose of radiation to the tumor site (known as SBRT with a focal boost). The goal is to see which method works better in helping to control the cancer while keeping side effects low.

To participate in this trial, men must be 18 years or older and have been diagnosed with prostate cancer that has not spread beyond the prostate. They should also have specific risk factors that categorize them as having intermediate or high-risk prostate cancer. Participants can expect to receive either the standard treatment or the experimental treatment and will be monitored closely for side effects and outcomes. This study is currently recruiting participants and aims to provide important information on the effectiveness of these different radiation therapy approaches.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Men ≥ 18 years with histologically confirmed prostate adenocarcinoma
• • No evidence of lymph node or distant metastases N0M0.
• • MRI visible tumor on mpMRI (PI-RADS v2 ≥ 4).
• * Intermediate- or high-risk PCa, defined as at least one of the following risk criteria (note; both the clinical T-stage and imaging T stage are noted in the CRF):
• • clinical stage cT2c-T3a (UICC TNM 8th edition)
• • Imaging stage T2c, T3a or T3b with less than 5 mm invasion in the seminal vesicles (as defined on mp MRI)
• • ≥ Gleason score 4+3, (ISUP Grade groups 3,4 or 5)
• • PSA ≥ 20 ng/mL
• • World Health Organization (WHO) performance score ≤ 2
• • International prostate symptoms score (IPSS score) \< 15
• • PSA ≤ 30 ng/mL
• • Prostate volume ≤ 90 cc on MRI
• • Ability to give written informed consent and willingness to return for follow-up
• Exclusion Criteria:
• • Prior pelvic radiotherapy
• • TURP (transurethral prostate resection) within 6 months from start treatment
• • On-line image guidance based on either fiducial markers or high-quality CBCT or MRI according to local guidelines not feasible. For example: Unsafe to have gold fiducial marker implantation, if gold fiducial markers are used for image guidance. Distorted images on MR because of hip protheses prohibit accurate MR image guidance, if MR is used for image guidance.
• • Contraindications to MRI according to local hospital guidelines.