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MRI-guided Brachytherapy and Salvage SBRT Program

ConditionProstate Cancer (Post Prostatectomy)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-80
SponsorClinica Universidad de Navarra, Universidad de Navarra

About this trial

Brachytherapy followed by MRI-guided irradiation has the potential to improve treatment results in patients with local relapses after radical prostatectomy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathological confirmation is advised in all cases but it is not mandatory .

Distance < 5mm from the edge of the IPBR to any of the defined OARs (UV anastomosis, rectal wall, bladder wall, external urinary sphincter)

Distant Metastases

Isolated nodal relapses

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Brachytherapy and MR-Guided SBRT

    Radiation

    HDR Brachytherapy followed by MR-guided SBRT

Treatment groups

29 Participants
are divided into 1 treatment group
Group A: MRI-guided Brachytherapy and Salvage SBRT ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Biochemical control

To achieve 5-year biochemical control rate in 85% of the patients.

Time frame
5-year
2

Adverse Events

To decrease urinary grade 3 or greater toxicity below 3% and rectal grade 3 or greater toxicity below 1%.

Time frame
5-year

Secondary outcomes

1

QOL

Determination of QOL with the EORTC QLQ-PR25

Time frame
From enrollment to extended follow-up at 5 years with QOL assessment at 3, 6, 12 months after treatment and yearly thereafter

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clinica Universidad de Navarra, Universidad de Navarra

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: