Focused Stereotactic Radiation Treatment of Prostatic Adenocarcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2023-01-31

Brief Summary

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Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure.

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Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Cyberknife

Intervention Type RADIATION

Eligibility Criteria

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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.

Eligible Sex

MALE

Accepts Healthy Volunteers

No