Observational study on extreme hypofractionation for localized prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• UZ Leuven
  Leuven, Vlaams Brabant, Belgium Recruiting

Study contacts

• Principal investigator: Gert De Meerleer, MD, PhD — UZ Leuven
• Study coordinator: Charlien Berghen, MD, PhD
• Email: charlien.berghen@uzleuven.be
• Phone: +3216347600

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• High Dose Rate Brachytherapy for Prostate Cancer Recurrence

  This study is testing if a special type of radiation treatment called High Dose Rate Brachytherapy can help men with prostate cancer that has come back after surgery feel better and have fewer side effects compared to regular radiation.

  Recruiting Clinica Universidad de Navarra, Universidad de Navarra · Pamplona, Foral Community of Navarre · NCT06982469

• Comparing two types of radiation therapy for prostate cancer treatment

  This study is testing whether a new type of radiation therapy for prostate cancer works better and is safer than a different method, while also looking at how well the treatment is tolerated by patients.

  Recruiting CHU de Quebec-Universite Laval · Québec · NCT05786742

• Analysis of outcomes and side effects in patients receiving radiation therapy

  This study looks at the results and side effects of radiation therapy in patients at Winterthur Cantonal Hospital to see how treatment can be improved for future patients.

  Recruiting Kantonsspital Winterthur KSW · Winterthur, Canton of Zurich · NCT05192876

• Using MRI scans to monitor cancer treatment response during radiation therapy

  This study is testing if regular MRI scans can help doctors see how well radiation therapy is working for patients with advanced cancers like glioblastoma and esophageal cancer.

  Recruiting at 2 sites Dana-Farber Cancer Institute · Boston, Massachusetts and 1 other locations · NCT04188535

• Primary tumor removal with targeted lymph node removal plus radiation for biliary tract cancer with lymph node spread

  This phase II study tests whether removing the main tumor and select nearby lymph nodes, followed by postoperative radiation, helps patients with biliary tract cancer and lymph node metastases.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT07893392

• Targeted alpha therapy for B7-H3 expressing solid tumors using AKY-2519

  This phase 1b trial tests a radiolabeled drug (AKY-2519) to see if it's safe and tolerable in adults with B7-H3 positive advanced solid tumors, including NSCLC and SCLC, with imaging to help guide use.

  Recruiting at 2 sites Phase 1 Aktis Oncology, Inc. · Miami, Florida and 1 other locations · NCT07887971

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.