Two-fraction radiotherapy 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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

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

• PSMA-targeted therapy with hormone suppression for low-volume metastatic prostate cancer

  This phase II trial tests leuprolide acetate alone versus with 177Lu-PSMA-617 (with or without abiraterone acetate and prednisone) in men with hormone-sensitive, low-volume metastatic prostate cancer.

  Recruiting Phase 2 Mayo Clinic · Rochester, Minnesota · NCT07650240

• Effects of exercise therapy on prostate cancer indicators

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• MRI-based microboost SBRT with de-escalated whole-gland radiation for localized prostate cancer

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  Recruiting Phase 2 Georgetown University · Washington D.C., District of Columbia · NCT07644598

• Lower-dose radiation to parts of the prostate for some men with prostate cancer

  This study tests whether a smaller amount of radiation aimed at specific parts of the prostate can reduce side effects compared with giving the full prostate the same dose.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07635238

• Short-term hormone therapy with PSMA PET/CT before prostate removal for high-risk localized prostate cancer

  This trial will test whether giving short-term androgen-deprivation therapy (ADT) before prostate removal lowers PSMA PET signal and helps predict recurrence risk in men with localized high-risk prostate cancer.

  Recruiting Phase 2 Baptist Health South Florida · Miami, Florida · NCT07455903

• PSMA PET/CT plus MRI to find higher‑grade prostate cancer in men on active surveillance

  This study tries adding rhPSMA-7.3 (flotufolastat F18) PET/CT to standard mpMRI to see if it finds higher-grade prostate cancer in men on active surveillance.

  Recruiting Phase 2 Icahn School of Medicine at Mount Sinai · New York, New York · NCT07285057

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.