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Feasibility of MRI-guided focal salvage high-dose-rate brachytherapy for locally recurrent prostate cancer

Feasibility of MRI-guided focal salvage high-dose-rate brachytherapy for locally recurrent prostate cancer - MRI-guided focal salvage HDR-BT for locally recurrent prostate cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47701
Enrollment
30
Registered
2013-04-16
Start date
2013-07-11
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

prostate cancer recurrent prostate carcinoma

Interventions

High-dose-rate brachytherapy will be performed for patients with recurrent prostate carcinoma. The treatment will include a single fraction of 19 Gy. Salvage high-dose-rate brachytherapy will be per

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age >=18 years - Biopsy proven local recurrence - Biopsy proven recurrence at least 2 years after primary radiotherapy treatment (low-dose-rate brachytherapie or external beam radiation therapy) - Limited and non-aggressive tumor presentation at time of salvage (Prostate Spedific Antigen (PSA) at time of salvage =70 - Written informed consent - Fit for spinal anaesthesia

Exclusion criteria

Exclusion criteria: - Distant metastasis - Severe toxicity during primary radiation treatment (International Prostate Symptom Score (IPSS)>15) - Patients who meet exclusion criteria for MRI following the protocol of the radiology department of the UMC Utrecht - Anticoagulant administration continuously required, except for Ascal - Discongruence between prostate biopsies and contrast MR imaging - No prior prostate cancer treatment(s) (like a recent TURP (

Design outcomes

Primary

MeasureTime frame
Incidence of grade>=3 gastro-intestinal and/or urogenital toxicity after MRI guided focal salvage therapy for locally recurrent prostate cancer. Toxicity will be determined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (National Cancer Institute).

Secondary

MeasureTime frame
- To determine the technical feasibility of MRI guided focal high-dose rate brachytherapy as salvage therapy for locally recurrent prostate cancer - Quality of life - Biochemical disease free survival (Phoenix criteria)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 19, 2026