Two-fraction radiotherapy for localized prostate cancer
Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk, Localized Prostate Cancer (TURBO): Phase 2, Randomized Controlled Clinical Trial
This study is testing if giving radiotherapy in just two sessions instead of five can effectively treat localized prostate cancer while causing fewer side effects for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | UMC Utrecht Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Utrecht) |
| Trial ID | NCT06518226 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of delivering radiotherapy in two fractions for patients with intermediate risk, localized prostate cancer, comparing it to the standard five-fraction treatment. Participants in the intervention group will receive 12 Gy per fraction with a tumor boost, while the control group will receive 7.25 Gy per fraction without a boost. The study will assess the occurrence of acute genitourinary side effects and aims to optimize treatment duration and costs while maintaining quality of life. The use of MR-guided adaptive radiotherapy (MRgRT) allows for precise targeting of the tumor, potentially reducing toxicity.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with histopathologically confirmed intermediate risk prostate adenocarcinoma requiring radical treatment.
Not a fit: Patients with contraindications to MRI, significant comorbidities, or previous pelvic radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to shorter treatment times and improved quality of life for patients with localized prostate cancer.
How similar studies have performed: Previous studies have shown the feasibility of hypofractionated radiotherapy, but this specific approach using MRgRT is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Histopathological confirmation of prostate adenocarcinoma requiring radical treatment * European Association of Urology (EAU) intermediate risk prostate cancer, defined as Prostate Specific Antigen (PSA) level of \< 20 ng/ml, Gleason score ≤ 7, cT1c-cT2b/iT3a (non-bulky, \< 20mm) * Written informed consent * Ability and willingness to comply with Patient Reported Outcome Measure (PROM) questionnaires schedule throughout the study * Inclusion in the Multi-OutcoMe EvaluatioN of radiation Therapy Using the MR-Linac Study (MOMENTUM) Exclusion Criteria: * Contraindications to MRI * International Prostate Symptom Score (IPSS) of 15 or higher * Prostate volume \> 80 cc * Comorbidities which predispose to significant toxicity (e.g., inflammatory bowel disease) * Metal pelvic implants which cause artefact on MR-imaging sequences * Previous radical prostatectomy * Previous pelvic radiotherapy * Previous invasive malignancy within the last 5 years, excluding basal cell carcinoma of the skin
Where this trial is running
Utrecht
- University Medical Center Utrecht — Utrecht, Netherlands (Recruiting)
Study contacts
- Study coordinator: Tariq A. Lalmahomed, MD
- Email: t.a.lalmahomed-2@umcutrecht.nl
- Phone: +31 (0)887574536
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.