Robotic and Focused Stereotactic Radiation Treatment of Good Prognosis Prostatic Adenocarcinoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Centre Francois Baclesse, Luxembourg
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Delay between the initial diagnosis and date of salvage treatment
- Last Updated
- 3 years ago
Overview
Brief Summary
Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure.
Detailed Description
Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure. Second objectives : objectives: prostate-specific antigen (PSA) response, MRI response, toxicity (CTCAEv4), quality of life (International Prostate Symptom Score (IPSS) and The International Index of Erectile Function (IIEF5) scores). Method At first: Multiparametric Magnetic resonance imaging (MRI) - 12 biopsies within the whole gland. Placement under endorectal ultrasound control of 4 fiducials at least 2 cm spaced. Treatment : CyberKnife radiation treatment delivering 36.25 Gy in 5 fractions, in 10 days. Tracking using the 4 fiducials. Critical organs: Rectal and bladder wall: V35\<2cc. Bladder neck and urethra: V35\<1cc. Salvage treatments: in such a context, salvage surgery or salvage intensity modulation radiation therapy (IMRT) treatments can in theory remain valid and safe options.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Prostatic adenocarcinoma of Capra score≤2 invading no more than two adjacent of the 12 prostatic zones. Lesions\>3mm. Maximal urinary flow rate ≥ 10ml/s, mean flow rate ≥ 5ml/s, post micturation volume ≤80ml, IPSS score ≤15.
Exclusion Criteria
- •systemic disease, ulcerative hemorrhagic ulcer or Crohn diseases, bladder neck stenosis, urethral implants, transurethral prostatectomy (TURP), any recurrent prostatitis within the last 3 years.
Outcomes
Primary Outcomes
Delay between the initial diagnosis and date of salvage treatment
Time Frame: through study completion, up to 36 months
Delay between the initial diagnosis and date of salvage treatment
Secondary Outcomes
- IPSS evaluation(12, 24, 36 months)
- PSA evaluation(3, 6, 12, 18, 24, 30, 36 months)
- Acute and late toxicity(3, 6, 12, 18, 24, 30, 36 months)
- IIEF5 evaluation(12, 24, 36 months)
- Birads score evaluation(12, 24, 36 months)