Health TrialsbyHealthPanel

Partial Prostate Salvage High Dose Rate Brachytherapy

ConditionRecurrent Prostate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age45+
SponsorBritish Columbia Cancer Agency

About this trial

A dose-response relationship for radiation in the management of prostate cancer is well established. Local recurrence of prostate cancer after external beam radiotherapy occurs in at least 40% of patients treated because of inability to deliver sufficient dose through external beam techniques. These patients respond well to re-irradiation using brachytherapy with about 50% of selected patients remaining free of recurrence 5 years after salvage. Advanced imaging using multiparametric Magnetic Resonance Imaging (mpMRI) allows identification of the site of recurrence, permitting partial prostate salvage brachytherapy. There is extensive literature on Low Dose Rate salvage brachytherapy but less on High Dose Rate.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >45 and Life expectancy >10 years

Previous External Beam Radiotherapy (EBRT) or LDR brachytherapy w

> 3 year interval since EBRT or LDR Brachytherapy

No late toxicity from prior EBRT ≥ grade 2

Disqualifiers

Not compliant with criteria above

Unable to give informed consent

Trial design

Design model

Single group

Treatments tested in this trial

  • HDR partial prostate brachytherapy

    Radiation

    temporary radioactive implant

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: HDR partial prostate brachytherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Late adverse gastrointestinal or genitourinary events grade 3 or higher

Common Terminology Criteria for Adverse Events (CTCAE V4.0)

Time frame
3-60 months

Secondary outcomes

1

Late Quality of Life

Expanded Prostate Cancer Index (EPIC)

Time frame
3-60 months
2

Late lower urinary tract symptoms

International Prostate Symptom Score

Time frame
3-60 months
3

Acute grade 3 or higher gastrointestinal or genitourinary adverse events

Common Terminology Criteria for Adverse Events (CTCAE V4.0)

Time frame
0-3 months
4

Acute Quality of Life changes

Expanded Prostate Cancer Index (EPIC)

Time frame
0-3 months

Other outcomes

Sponsors and contacts

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

British Columbia Cancer Agency

Lead sponsor

Source ClinicalTrials.gov
Apply now