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Dosnedtrappning vid prostatastrålbehandling med MR-Linac i två fraktioner (DESTINATION 2)

3 november 2026 uppdaterad av: The Netherlands Cancer Institute

Dosdeeskalering vid strålbehandling av prostatacancer med MR-Linac i 2 fraktioner

The goal of this clinical trial is to find out whether lowering the radiation dose to parts of the prostate without visible tumor on MRI can reduce side effects while still effectively treating prostate cancer in men with low or intermediate-risk prostate cancer.

The main questions it aims to answer are:

  • Does reducing the radiation dose to healthy prostate tissue lower the risk of bowel and urinary side effects?
  • Can we maintain good cancer control by keeping a high dose for MRI-visible tumor areas?

Researchers will compare two treatment approaches:

  • One group receives a uniform high dose to the entire prostate.
  • The other group receives a lower dose to healthy prostate tissue and a high dose only to visible tumor areas.

Participants will:

  • Receive two sessions of MRI-guided radiotherapy using an MR-Linac.
  • Complete questionnaires about urinary, bowel, and sexual health before and after treatment.
  • Have follow-up visits to monitor side effects and PSA levels for up to 2 years.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

54

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Floris Pos, MD, PhD
  • Telefonnummer: +31205129111
  • E-post: f.pos@nki.nl

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Manlig

Beskrivning

Inclusion Criteria:

  1. Men aged ≥18 years
  2. Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy
  3. Gleason score 3+3, 3+4 or 4+3 (ISUP Grade groups (GG) 1, 2 or 3)
  4. MRI-visible tumour(s) of PIRADS v2 grade 3 or higher and able to be delineated on T2 and diffusion-weighted imaging +/- dynamic contrast-enhanced imaging. Tumour nodule visible on MRI should be considered able to be boosted by treating clinician and <2.5cm in maximal dimension. MRI must be performed within 3 months of trial entry
  5. The MRI-defined lesion must be confirmed as malignant on biopsies (any Gleason grade is sufficient as long as Gleason score is reported).
  6. MRI stages mT1 and T2 or mT3a with ≤ 1mm tumour outside gland AND otherwise favourable intermediate risk characteristics (Gleason 3+3, 3+4)(as staged by AJCC TNM 2018)
  7. PSA <20 ng/ml prior to starting androgen deprivation therapy (ADT).
  8. WHO Performance status 0-2
  9. Ability of the participant to understand and the willingness to sign a written informed consent (IC) form.
  10. Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study.

Exclusion Criteria:

  1. Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)
  2. IPSS Score > 19
  3. High grade disease (GG3) occult to MRI-defined lesion. As a guide, any pathology for which you would consider surveillance is allowed outside of the MRI-defined area.
  4. Prostate volume >90cc
  5. Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up
  6. Hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging
  7. Previous pelvic radiotherapy
  8. Patients needing >6 months of ADT due to disease parameters.
  9. Previous invasive malignancy within the last 2 years excluding basal or squamous cell carcinomas of the skin, low risk non-muscle invasive bladder cancer (assuming cystoscopic follow up now negative) or small renal masses on surveillance.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: Uniform dos SBRT
Strålning: uniform dose radiotherapy

27 Gy dose in 2 fractions to the whole prostate+/- seminal vesicles with a 0mm PTV margin using MR-linac
Övrig: Deeskalerad dos SBRT
Strålning: De-escalated dose radiotherapy

The benign prostate +/- SV CTV will receive 20 Gy in 2 fractions with a 0mm PTV margin using MR-linac. The intraprostatic tumor masses (on MRI) will receive 27 Gy in 2 fractions. A 4mm GTV to PTV margin will be added to the in-traprostatic MR visible tumour to form PTV 27Gy.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Acute GU toxicity
Tidsram: within 13 weeks of starting radiotherapy

Physician-reported acute Grade 2 or higher CTCAE GU toxicity observed within 13 weeks of starting radiotherapy
within 13 weeks of starting radiotherapy

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Dosimetry
Tidsram: During Radiotherapy treatment of 8 days

Estimate the accumulated dose differences between treatment arms in terms of dose to prostate CTV, rectum, urethra and bladder
During Radiotherapy treatment of 8 days
Late GI toxicity
Tidsram: 1 and 2 years after radiotherapy treatment

Physician reported late GI toxicity according to CTCAE v5.0
1 and 2 years after radiotherapy treatment
Biochemical relapse-free survival
Tidsram: 2 years

Assess biochemical relapse-free survival for 2 years
2 years
Severity of erectile dysfunction experienced by patient
Tidsram: Before radiotherapy treatment, and at 6, 12 and 24 months after radiotherapy treatment

The IIEF-5 patient reported outcomes (PROs) assess the acute severity of erectile dysfunction
Before radiotherapy treatment, and at 6, 12 and 24 months after radiotherapy treatment
Acute GI toxicity
Tidsram: At baseline, after the last fraction, and 2, 4 and 12 weeks after radiotherapy treatment

Physician reported acute GI toxicity according to CTCAE v5.0
At baseline, after the last fraction, and 2, 4 and 12 weeks after radiotherapy treatment
Late GU toxicity
Tidsram: 1 and 2 years after radiotherapy treatment

Physician reported late GU toxicity according to CTCAE v5.0
1 and 2 years after radiotherapy treatment
Late sexual toxicity
Tidsram: 1 and 2 years after radiotherapy treatment

Physician reported late sexual toxicity according to CTCAE v5.0
1 and 2 years after radiotherapy treatment
Severity of urinary symptoms (GU) experienced by patient
Tidsram: Before radiotherapy treatment, after the last fraction, at 2, 4 and 12 weeks post-treatment, and at 6, 12 and 24 months after radiotherapy treatment

The patient reported outcomes (PROs) International Prostate Symptoms Score (IPSS) assess the severity of urinary symptoms what the patient experiences
Before radiotherapy treatment, after the last fraction, at 2, 4 and 12 weeks post-treatment, and at 6, 12 and 24 months after radiotherapy treatment
Health-related quality of life experienced by patient
Tidsram: Before start radiotherapy, week 4 and week 12, at 6, 12 and 24 months after radiotherapy treatment.

The EPIC-26 patient reported outcomes (PROs) assess the health-related quality of life
Before start radiotherapy, week 4 and week 12, at 6, 12 and 24 months after radiotherapy treatment.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The Netherlands Cancer Institute

Samarbetspartners

Elekta Limited
Radiotherapiegroep
MRL Consortium

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

17 november 2025

Primärt slutförande (Beräknad)

1 februari 2027

Avslutad studie (Beräknad)

1 december 2028

Studieregistreringsdatum

Först inskickad

2 oktober 2025

Först inskickad som uppfyllde QC-kriterierna

2 februari 2026

Första postat (Faktisk)

6 februari 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • M24DTI

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

It is intended that data will be shared within the MOMENTUM collaboration, between centres delivering treatment in the same way as DESTINATION2. Pseudonymised data will be stored within MOMENTUM for at least 5 years. Storage will be cloud based and as the treating centre we will have free access to the data and control over who else can assess it.

Tidsram för IPD-delning

5 years

Läkemedels- och apparatinformation, studiedokument

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Nej

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Nej

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