Observational Study on Extreme Hypofractionation for Localized Prostate Cancer

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Apr 19, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat localized prostate cancer using a method called extreme hypofractionation or stereotactic body radiotherapy (SBRT). This treatment delivers higher doses of radiation in fewer sessions, which can make the treatment process quicker and potentially just as effective as traditional methods. The researchers want to see if this approach works well and is safe for men with intermediate or select high-risk prostate cancer, especially those who may have existing urinary issues.

To participate in the trial, men must be at least 18 years old and have a confirmed diagnosis of localized prostate cancer that meets certain risk criteria. They shouldn't have had previous radiation treatments or surgeries for prostate cancer, and they need to be able to undergo specific imaging tests. Participants can expect to receive specialized radiation therapy while helping researchers gather important information about this treatment option. It’s important to know that while this trial is seeking to include a broader range of patients, some individuals with certain health conditions may not be eligible.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • men ≥ 18 years
• • histologically confirmed clinically localized adenocarcinoma of the prostate
• • intermediate- or high-risk PCa, defined as
• OR at least one of the following criteria:
• • clinical stage: cT2a-c, cT3a or cT3b (AJCC 7th edition)
• • Gleason Score ≥ 7 (ISUP grade group 2 or higher)
• OR at least two of the following criteria:
• • clinical stage: cT1c (AJCC 7th edition)
• • Gleason Score ≥ 7 (ISUP grade group 2 or higher)
• • calculated risk for lymph node involvement (Roach formula) \<35%.
• • no evidence of disease spread beyond the prostate and/or seminal vesicles
• • imaging with mpMRI of the prostate and pelvis (compliant with the PIRADS v2.1 guidelines) within 90 days prior to registration, or required to be performed after registration to the trial
• • ability to understand, and willingness to sign, the written informed consent
• • willingness to comply with scheduled visits, treatment, and other procedures
• Exclusion Criteria:
• • prior pelvic irradiation (external beam radiotherapy or brachytherapy)
• • previous radical prostatectomy, cryosurgery, or HIFU for prostate cancer
• • previous or concurrent cytotoxic chemotherapy for prostate cancer
• • patients with neuroendocrine or small cell carcinoma of the prostate
• • clinical stage cT4 (invasion of adjacent organ like bladder or rectum, visualized on mpMRI and/or ultrasound and endoscopy) (AJCC 7th edition)
• • significant urinary obstruction of other voiding symptoms (IPSS \> 18) is allowed, however should be discussed with the principal investigator and left to the discretion of the treating physician
• • high risk of lymph node involvement, as calculated with the Roach formula ≥ 35% (https://www.evidencio.com/models/show/1144) Of note, in case of ambiguity of regional lymph node involvement on CT or MRI findings (when Roach formula is \< 35%, and all other eligibility criteria are met), dedicated imaging with PSMA PET-CT or extended pelvic lymph node dissection must be obtained to rule out lymph node involvement
• • evidence of distant metastases (based on CT scan, MRI of the pelvis, bone scan within 90 days prior to registration; if the bone scan is suspicious but not unequivocal, dedicated X-ray and/or MRI must be obtained to rule out metastasis)
• • contraindications to MRI according to the Radiology Department guidelines (metal implants, noncompatible cardiac device, deep brain stimulators, cochlear implants, metallic foreign body in the eye or aneurysm clips in the brain, severe claustrophobia).
• • World Health Organization (WHO) performance score \> 2
• • patients with severe inflammatory bowel disease rendering radiotherapy impossible (active Crohn's Disease or Ulcerative Colitis), or patients known with ataxia telangiectasia
• • implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
• • prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease-free for a minimum of 5 years.
• • (carcinoma in situ of the bladder or oral cavity is permissible)