Prostate Cancer
Conditions
Keywords
prostate cancer, good prognosis, focused treatment, Cyberknife
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.
Interventions
RADIATIONCyberknife
Sponsors
Centre Francois Baclesse, Luxembourg
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delay between the initial diagnosis and date of salvage treatment | through study completion, up to 36 months | Delay between the initial diagnosis and date of salvage treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PSA evaluation | 3, 6, 12, 18, 24, 30, 36 months | PSA dosage |
| Birads score evaluation | 12, 24, 36 months | Multiparametric prostatic MRI |
| Acute and late toxicity | 3, 6, 12, 18, 24, 30, 36 months | Acute and late toxicity using the CTCAEv4 |
| IPSS evaluation | 12, 24, 36 months | IPSS score |
| IIEF5 evaluation | 12, 24, 36 months | IIEF5 score |
Countries
Luxembourg
Outcome results
None listed