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Focal Salvage Brachytherapy Study (FocaSaBra)

ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorThe Greater Poland Cancer Centre

About this trial

The aim of this prospective phase II study is to evaluate the toxicity of salvage partial (focal) prostate brachytherapy in patients after prior radiotherapy (standard teleradiotherapy with / without brachytherapy, hypofractionated, self-reactive HDR / LDR brachytherapy) with local recurrence on the part of the prostate gland.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histopathologically confirmed by biopsy (fusion mapping biopsy preferred) recurrence of prostate cancer after prior radical radiotherapy (brachytherapy, external beam radiotherapy alone or with brachytherapy boost, stereotaxic radiotherapy)

Localized tumor lesion assessed by MRI or in the case of MR contraindications with TRUS and CT

Exclusion of distant metastases using CT, MR, or PET imaging

PSA doubling time over six months

Disqualifiers

PSA value> 10ng / ml

General condition according to the WHO scale> 2

Dysuria on the IPSS scale> 20 points

PSA doubling time <6 months

Trial design

Design model

Single group

Treatments tested in this trial

  • brachytherapy

    Radiation

    Radiation: focal low dose rate or high dose rate brachytherapy for the lesion with appropriate margin, defined in magnetic resonance or positron emission tomography All recruited participants will be treated with interstitial brachytherapy for local recurrence of prostate cancer. The low dose rate of brachytherapy is used with a total dose of 145 Gy in the clinical target volume for participants after hypofractionated radiotherapy, a high dose rate brachytherapy as monotherapy or boost with external beam radiotherapy The high dose rate brachytherapy with two fractions of 13 Gy in the clinical target volume with a 3 to 14 days break is used after primary low dose rate brachytherapy or external beam radiotherapy alone.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: ExperimentalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Assessment of the change in the urological toxicity in points with the International Prostate Symptoms Scale

Assessment of the change in the urological toxicity in points with the International Prostate Symptoms Scale - IPSS within 0-35 points

Time frame
change from baseline to 24 months of follow-up
2

Assessment of the change in the erectile function in points with the International Index of Erectile Function 5 (IIEF-5) (0-25 points)

Assessment of the change in the erectile function in points with the International Index of Erectile Function 5 (IIEF-5): scale 0-25 points

Time frame
change from baseline to 24 months of follow-up
3

Assessment of the change in the quality of life in points with EORTC C30 and PR25 protocols. (0-100 points)

Assessment of the change in the quality of life in points with EORTC C30 and PR25 protocols, scale: 0-100 points

Time frame
change from baseline to 24 months of follow-up

Secondary outcomes

1

Assessment of the adverse events in the percentage of grades with the CTCAE v4.0

Assessment of the adverse events in the percentage of grades with the CTCAE v4.0 scale: 0-5 grades

Time frame
24 months after treatment

Other outcomes

Sponsors and contacts

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

The Greater Poland Cancer Centre

Lead sponsor

Source ClinicalTrials.gov
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