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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27850
Enrollment
30
Registered
2016-10-17
Start date
2013-05-01
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 (HDR) brachytherapy, radiorecurrent disease.

Interventions

Single fraction HDR treatment to a dose of 19 Gray

Sponsors

University Medical Center Utrecht
Lead Sponsor

Eligibility

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 brachytherapy or external beam radiation therapy); - Limited and non-aggressive tumor presentation at time of salvage (PSA at time of salvage 70; - Written informed consent; - Fit for anaesthesia.

Exclusion criteria

Exclusion criteria: - Distant metastases; - Severe toxicity from primary radiation treatment (IPSS>15); - Patients who meet exclusion criteria for MRI following the protocol of the radiology department of the UMC Utrecht (see appendix); - Anticoagulant administration continuously required, except for Ascal; - Discongruence between prostate biopsies and contrast MR imaging; - Prior prostate treatment(s) (like a recent TURP (<6 months before focal salvage HDR treatment), HIFU, cryosurgery), except for radiotherapy.

Design outcomes

Primary

MeasureTime frame
To investigate the occurrence of gastrointestinal and/or genitourinary toxicity after focal salvage HDR-BT for locally recurrent prostate cancer.

Secondary

MeasureTime frame
- To determine the technical feasibility of MRI guided focal HDR-BT as salvage treatment for locally recurrent prostate cancer; - Quality of life; - Biochemical disease free survival (as defined by Phoenix criterium nadir+2)

Contacts

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

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)