Observational study on extreme hypofractionation for localized prostate cancer

This study tests a new type of radiation treatment for men with localized prostate cancer to see if giving higher doses in fewer sessions can work better and be safer than the usual methods.

Quick facts

• Study type: Observational
• Enrollment: 246 (estimated)
• Sex: Male
• Sponsor: Universitaire Ziekenhuizen KU Leuven (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Leuven, Vlaams Brabant)
• Trial ID: NCT05344235 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness and safety of extreme hypofractionation, specifically stereotactic body radiotherapy (SBRT), for treating localized prostate cancer. It focuses on patients with intermediate- or high-risk prostate cancer, utilizing a higher dose per fraction to potentially improve treatment outcomes while reducing the number of treatment sessions. The study aims to gather data on patient responses to this innovative radiotherapy approach, contributing to the understanding of its benefits compared to traditional methods.

Who should consider this trial

Good fit: Ideal candidates for this study are men aged 18 and older with histologically confirmed localized adenocarcinoma of the prostate and classified as intermediate- or high-risk.

Not a fit: Patients with prior pelvic irradiation or those with evidence of disease spread beyond the prostate and/or seminal vesicles may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and efficient treatment option for patients with localized prostate cancer.

How similar studies have performed: Other studies have shown promising results with similar approaches to hypofractionated radiotherapy, indicating potential for success in this area.

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)

Where this trial is running

Leuven, Vlaams Brabant

• UZ Leuven — Leuven, Vlaams Brabant, Belgium (RECRUITING)

Study contacts

• Principal investigator: Gert De Meerleer, MD, PhD — UZ Leuven
• Study coordinator: Charlien Berghen, MD, PhD

Conditions: Prostate Cancer, Radiotherapy, SBRT