Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk, Localized Prostate Cancer

NCT06518226 | Recruiting

• 1 other identifier: NL85364.041.23
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess the non-inferiority irradiating low and intermediate risk, localized prostate cancer in two fractions of radiotherapy, compared to five fractions of radiotherapy which is the standard of care. The main question it aims to answer are: \- Do participants in the interventional arm have more physician-reported grade 2 or higher acute Common Terminology Criteria for Adverse Events (CTCAE) genitourinary (GU) side effects? Participants in the intervention arm will receive two fractions of radiotherapy, in which the prostate is irradiated with 12 Gy per fraction and the tumor receives a boost of up to 13.5 Gray (Gy), over the course of 8 days. Those in the control arm will receive five fractions of radiotherapy of 7.25 Gy each to the prostate, without a boost to the tumor, over the course of 16-18 days.

Conditions

Prostate Cancer; Prostate Adenocarcinoma; Localized Prostate Carcinoma

Keywords

MR-guided adaptive radiotherapy; MRgRT; Quality of life; Patient-reported outcomes; Ultrahypofractionation

Outcome Measures

Primary Outcomes (1)

• Incidence of acute grade >= 2 genitourinary (GU) physician-reported toxicity

  This is scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 scale. Scores will be retrieved from the hospital information system.

  90 days after treatment

Secondary Outcomes (7)

• Incidence of acute grade >= 2 gastrointestinal (GI) physician-reported toxicity

  Up to 5 years

• Incidences of late grade >= 2 GU physician-reported toxicity

  Up to 5 years

• Incidences of acute grade >= 2 GI physician-reported toxicity

  Up to 5 years

• Oncological treatment related quality of life (QoL)

  Up to 5 years

• Patient reported Health related quality of life (HRQoL)

  Up to 5 years

Study Arms (2)

Ultrahypofractionated MRgRT in 2 fractions

EXPERIMENTAL

MRgRT to the prostate in 2 fractions of 12 Gy, with a focal boost of 13.5 Gy to the gross tumor volume (GTV), administered over the course of 8 days.

Radiation: Ultrahypofractionated MRgRT in 2 fractions

Standard of care: MRgRT in 5 fractions

ACTIVE COMPARATOR

MRgRT to the prostate in 5 fractions of 7.25 Gy to the prostate without focal boost, administered over the course of 16-18 days.

Radiation: Standard of care: MRgRT in 5 fractions

Interventions

Ultrahypofractionated MRgRT in 2 fractions RADIATION

2x12 Gy with boost to GTV up to 13.5 Gy

Ultrahypofractionated MRgRT in 2 fractions

Standard of care: MRgRT in 5 fractions RADIATION

5x7.25 Gy

Standard of care: MRgRT in 5 fractions

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

RECRUITING

Related Publications (2)

• Westley RL, Biscombe K, Dunlop A, Mitchell A, Oelfke U, Nill S, Murray J, Pathmanathan A, Hafeez S, Parker C, Ratnakumaran R, Alexander S, Herbert T, Hall E, Tree AC. Interim Toxicity Analysis From the Randomized HERMES Trial of 2- and 5-Fraction Magnetic Resonance Imaging-Guided Adaptive Prostate Radiation Therapy. Int J Radiat Oncol Biol Phys. 2024 Mar 1;118(3):682-687. doi: 10.1016/j.ijrobp.2023.09.032. Epub 2023 Sep 29.

  PMID: 37776979 BACKGROUND

• Lalmahomed TA, Monninkhof EM, van Rijssel MJ, van Melick HHE, Verkooijen HM, de Boer JCJ, van der Voort van Zyp JRN. Two-fraction Ultrahypofractionated Radiotherapy with focal BOost for intermediate-risk, localized prostate cancer (TURBO): study protocol of a phase II, randomized controlled clinical trial. Trials. 2025 Dec 29;26(1):586. doi: 10.1186/s13063-025-09297-5.

  PMID: 41466435 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Tariq A. Lalmahomed, MD

CONTACT

+31 (0)887574536; t.a.lalmahomed-2@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 24, 2024
• Study Start: March 28, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): February 1, 2031
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)