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Clinical Trials/NL-OMON56580
NL-OMON56580
Recruiting
Phase 2

Two-fraction Ultra-hypofractionated Radiotherapy with Focal Boost for low- and intermediate risk, localized prostate cancer (TURBO):phase II, randomized controlled clinical trial - TURBO

niversitair Medisch Centrum Utrecht0 sites160 target enrollmentTBD
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Conditionsprostate adenocarcinomaprostate cancer100276561001818810036958

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
prostate adenocarcinoma
Sponsor
niversitair Medisch Centrum Utrecht
Enrollment
160
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
niversitair Medisch Centrum Utrecht

Eligibility Criteria

Inclusion Criteria

  • •Age \>\=18 years
  • •Histopathological confirmation of prostate adenocarcinoma requiring radical
  • •Intraprostatic tumor visible and delineable on diagnostic imaging
  • •EAU intermediate risk prostate cancer
  • •o PSA \< 20 ng/ml
  • •o Gleason score \<\= 7
  • •o cT1c\-cT2b/iT3a (non\-bulky, \< 20mm)
  • •Written informed consent
  • •Informed consent to share medical data and fill out quality of life
  • •questionnaires in the MOMENTUM study.

Exclusion Criteria

  • •Contraindication to MRI (e.g., pacemaker)
  • •IPSS 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 (e.g.,
  • •total hip replacement)
  • •Previous radical prostatectomy
  • •Previous pelvic radiotherapy
  • •Previous invasive malignancy within the last 5 years, excluding basal cell

Outcomes

Primary Outcomes

Not specified

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