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Salvage HDR for Locally Recurrent Prostate Cancer

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About this study

The study offers focal salvage brachytherapy for prostate cancer patients with a local recurrence after primary defintive radiotherapy

Condition
Prostate Cancer
Tested
High dose rate brachytherapy
Sponsor
Aarhus University Hospital

Who can join

Age
18 years and older
Sex
Male only
Healthy volunteers
Not accepted

Inclusion 17

  • Minimum age: 18 years
  • Eligible sex: Male
  • Study condition: Prostate Cancer
  • Man ≥ 18 years, who had definitive EBRT or BT for prostate cancer T1-3b, N0-1, M0
  • ≥ 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 7

  • Pubic arc interference or major calcifications within the prostate gland.
  • 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

Where

1 site, 1 recruiting

Department of Oncology

Aarhus, Region Midt, Denmark

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.