Focal Brachytherapy in Patients With Selected Low-risk Prostate Cancer - a Phase-II-trial
Who is this study for? Adult patients with prostate cancer
What treatments are being studied? HDR-Brachytherapy
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This trial examines the feasibility and toxicity of focal brachytherapy in patients with low-risk prostate cancer.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• Age \> 18
• Histologically confirmed prostate cancer
• Gleason Score of index lesion ≤ 6 (3+3)
• Tumor stage: cT1-2a cN0 cM0
• Unilateral affection; index lesion ≤ 0.5ml with or without clinically non-significant lesion contralateral. No more than 25% of the punch should be affected. Therefore a 3D-TPM-biopsy is mandatory before treatment.
• PSA ≤ 10/ng/ml
• Prostate volume \< 60 m\^3
• No distant metastasis
• Life expectancy \> 10 years
• Informed consent
Locations
Other Locations
Germany
University Hospital
RECRUITING
Erlangen
Time Frame
Start Date: 2014-10
Estimated Completion Date: 2029-12
Participants
Target number of participants: 50
Treatments
Experimental: Focal Brachytherapy
HDR-Brachytherapy, 2 fractions within at least 24 but max. 30 hours, each 13,5 Gy
Related Therapeutic Areas
Sponsors
Leads: University of Erlangen-Nürnberg Medical School