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Clinical Trials/NL-OMON56376
NL-OMON56376
Withdrawn
Not Applicable

Towards optimal treatment for high risk prostate cancer; stereotactic pelvic radiotherapy with focal boost to the primary tumor - HypoPRIME

Haaglanden Medisch Centrum0 sites228 target enrollmentTBD
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Haaglanden Medisch Centrum
Enrollment
228
Status
Withdrawn
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

Eligibility Criteria

Inclusion Criteria

  • •\- Men (aged \>\=18 years of age) diagnosed within 6 months before inclusion with
  • •high risk prostate cancer:
  • •o T3 based on digital rectal examination AND/OR
  • •o Grade \>\= 4 AND/OR
  • •o PSA \>\=20 ug/L
  • •\- Indication for elective lymph node irradiation (based on current clinical
  • •guidelines) OR N1 on imaging (with a maximum of 4 suspect lymph nodes)

Exclusion Criteria

  • •Prior pelvic radiotherapy
  • •TransUrethral Resection of the Prostate (TURP) \< 3 months ago
  • •Prostatectomy or other primary treatment for prostate cancer (e.g. HIFU,
  • •cryotherapy, etc)
  • •contraindications to MRI
  • •no visible lesion on MRI in prostate for boost
  • •no PSMA\-PET scan
  • •inflammatory bowel disease
  • •metastatic disease (M1\)
  • •unsuitable for SBRT or WPRT

Outcomes

Primary Outcomes

Not specified

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