Single fraction high-dose-rate brachytherapy monotherapy in prostate cancer * Phase I-II trial

Completed

Conditions: low-risk prostate cancer
prostate carcinoma
10038364

Registration Number: NL-OMON46332

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

Men aged 18-80 years
Histological confirmation of prostate adenocarcinoma
Gleason score * 7
Clinical stage T1c-T2a, N0-X, M0
PSA * 15 ng/ml
WHO performance status 0-2
Prostate volume * 50 ml
IPSS score * 12
Maximum urinary flow rate * 15 ml/s at uroflowmetry and residual volume of < 100 ml
Ability and willingness to comply with follow-up and completion of questionnaires
Written informed consent.

Exclusion Criteria

Previous malignancy within the last 5 years, except basal cell carcinoma or squamous cell carcinoma of the skin
In case of Gleason score 7: more than 3 positive biopsies
Prior pelvic radiotherapy
Prior androgen deprivation therapy (including androgen agonists and antagonists)
Any prior active treatment for prostate cancer (Patients previously on active surveillance are eligible if they continue to meet all other eligibility criteria)
Life expectancy <5 years
Prior TURP (transurethral resection of the prostate)
Co-morbidity preventing general or spinal anesthesia
Hip prostheses or any other implants/hardware that would introduce substantial CT artifacts
Medical conditions likely to make radiotherapy inadvisable e.g. inflammatory bowel disease or significant urinary symptoms
Anticoagulation with coumarins or bleeding tendency making brachytherapy unsafe in the opinion of the clinician
Medical condition or implant that prohibits MRI imaging
Participation in another concurrent treatment protocol.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>In phase I the incidence of acute (up to 3 months after treatment)<br /><br>gastrointestinal (GI) and genitourinary (GU) toxicity grade 3 or higher will be<br /><br>determined for each dose level. In phase II the acute and one-year late<br /><br>toxicity incidences will be evaluated as primary endpoints. </p><br>

Secondary Outcome Measures