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Eenmalige plaatselijke inwendige bestraling voor de behandeling van patiënten met teruggekeerde prostaatkanker

PRostatE Cancer MRI guided focal SalvagE high-dose-rate brachytherapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20394
Enrollment
88
Registered
2018-02-05
Start date
2018-02-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer High-dose-rate brachytherapy Recurrent disease

Interventions

Single fraction focal high-dose-rate brachytherapy to a dose of 19 Gray

Sponsors

University Medical Center Utrecht
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Age >18 years; - Recurrence >2 years after primary radiotherapy treatment (LDR-BT or EBRT); - PSA at time of salvage 9 months; - Maximum stage T3b tumor (extra prostatic extension into the seminal vesicle(s)); - Acceptable toxicity of primary radiation treatment (IPSS 70 - Written informed consent; - Fit for spinal anesthesia.

Exclusion criteria

Exclusion criteria: - Distant metastases; - Previous pelvic radiotherapy for another malignancy; - Prior prostate treatment(s) like a recent transurethral resection of the prostate (TURP) (15); - Anticoagulant administration continuously required, except for platelet aggregation inhibitors (for example Ascal/Persantin).

Design outcomes

Primary

MeasureTime frame
To investigate the occurrence of acute and late (>3 months) grade >2 GI and/or GU toxicity (aiming for 2 toxicity) after MRI-guided focal salvage HDR-BT for locally recurrent prostate cancer.

Secondary

MeasureTime frame
- QoL; - Biochemical disease free survival; - Assessment of dose restrictions to prevent/reduce acute and late GU/GI toxicity; - Predictive factors for tumor control, to optimize patient selection.

Contacts

Public ContactJ.R.N. Voort van Zyp, van der

UMC Utrecht, Department of Radiotherapy

J.R.N.vanderVoortvanZyp@umcutrecht.nl+31 (0)88 7558800

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)