Status:
COMPLETED
SBRT in 4 Fractions for Prostate Cancer
Lead Sponsor:
Istituto Clinico Humanitas
Conditions:
Prostate Cancer
Eligibility:
MALE
18-85 years
Phase:
NA
Brief Summary
This is a prospective multicentric phase-I-II pilot feasibility study. The main objective is to study early and late side effects of hypofractionated accelerated RT for prostate cancer with FFF (Free ...
Eligibility Criteria
Inclusion
- Age ≤ 85years.
- WHO performance status ≤ 2.
- PSA\>10 and ≤ 20 ng/ml or Gleason Score 7 or T2a-T2c.
- Histologically proven prostate adenocarcinoma
- No pathologic lymph nodes on CT/ MRI scan.
- No distant metastases.
- No previous prostate surgery other than TURP (at least 6 weeks interval before initiation of RT).
- No malignant tumours in the previous 5 years.
- IPSS 0-7.
- Combined HT according to risk factors.
- Informed consent.
Exclusion
- Prostate size greater than 60cc.
- Previous TURP less than 6 weeks before radiotherapy.
- Previous prostate surgery other than TURP.
- Diabetes \*.
- Use of anticoagulants drugs \*.
- Chronic inflammatory bowel disease \*.
- Previous pelvic irradiation.
- Inability to obtain written informed consent.
Key Trial Info
Start Date :
June 12 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2018
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03873090
Start Date
June 12 2013
End Date
May 23 2018
Last Update
March 13 2019
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