Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2021-04-01
2035-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single arm
Single arm
High dose rate brachytherapy
High dose rate brachytherapy will be delivered to the site of recurrence within the prostate gland based on MRI and PSMA PET/CT
Interventions
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High dose rate brachytherapy
High dose rate brachytherapy will be delivered to the site of recurrence within the prostate gland based on MRI and PSMA PET/CT
Eligibility Criteria
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Inclusion Criteria
* ≥ 2 years since the end of primary radiotherapy
* PSA recurrence Phoenix criteria (nadir + 2)
* No evidence of regional lymph nodes or distant metastases on PSMA PET/CT
* MRI guided biopsy-proven local recurrence of adenocarcinoma in the prostate gland or seminal vesicles
* GTV identifiable on mpMRI
* No current endocrine therapy
* Plasma testosterone ≥1.75 nm/l
* PSA doubling time ≥ 6 months and ≤ 24 months
* Performance status 0-1
* DAN PSS score ≤ 20
* Maximal urinary flow ≥ 10 ml/s
* Life expectancy \> 5 years
* PSA ≤ 10 ug/L at recurrence
Exclusion Criteria
* Contraindication for spinal or general anaesthesia.
* Conditions indicating that the patient cannot go through the radiation therapy or follow-up, or a condition where the treating oncologist thinks the patient should not participate in the trial, for example due to language problems.
* Inflammatory bowel disease
* Contraindications to 3T MRI
* eGFR \< 30 ml/min
* ≥ Gr 3 urinary toxicity at baseline as assessed by CTCAE 4
18 Years
MALE
No
Sponsors
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Aarhus University Hospital
OTHER
Responsible Party
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Simon Buus
Principal investigator
Locations
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Department of Oncology
Aarhus, Region Midt, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1-10-72-218-19
Identifier Type: -
Identifier Source: org_study_id
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