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RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: uniform dose radiotherapy for Prostate Cancer (Adenocarcinoma)

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?

Official registry: https://clinicaltrials.gov/study/NCT07391982 · The Netherlands Cancer Institute · enrollment listed as 54

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are uniform dose radiotherapy, or De-escalated dose radiotherapy. The registry lists allocation as randomized. 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.

They plan to enroll about 54 people at Amsterdam. Taking part typically means a procedure as part of the study plus check-ins.

Official title (unrewritten)

Dose De-escalation in Prostate Radiotherapy Using an MR-Linac in 2 Fractions

Interventions: uniform dose radiotherapy, De-escalated dose radiotherapy

Primary outcome (registry wording): Acute GU toxicity

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Men only
  • Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy
  • Gleason score 3+3, 3+4 or 4+3 (ISUP Grade groups (GG) 1, 2 or 3)
  • The MRI-defined lesion must be confirmed as malignant on biopsies (any Gleason grade is sufficient as long as Gleason score is reported)
  • 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)
  • PSA \<20 ng/ml prior to starting androgen deprivation therapy (ADT)
  • WHO Performance status 0-2
  • Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study

Public study contact (from the registry)

Floris Pos, MD, PhD

+31205129111

f.pos@nki.nl

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07391982 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07391982?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07391982?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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