Status:
UNKNOWN
Short-term High Precision Radiotherapy for Early Prostate Cancer With Concomitant Boost on the Dominant Lesion
Lead Sponsor:
European Institute of Oncology
Conditions:
Adenocarcinoma of Prostate
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The present research project aims to improve the current treatment for prostate-confined tumor, evaluating the safety and feasibility of a very short hypofractionated radiotherapy schedule administere...
Detailed Description
Approximately 70% of men with newly diagnosed prostate cancer feature organ-confined disease. Conventional treatment options for prostate-confined cancer include radical prostatectomy, external beam r...
Eligibility Criteria
Inclusion
- \- Histologically confirmed adenocarcinoma of prostate, including the following 2011 National Comprehensive Cancer Network (NCCN) risk categories: very low (T1c PSA \<10 ng/ml, Gleason score \<7, fewer than 3 positive biopsy cores, \<50% cancer in each core, PSA density \<0.15 ng/ml) or low (T1-T2a, PSA \<10 ng/ml, Gleason score \<7) or intermediate (T2b or T2c, PSA between 10 and 20 ng/ml, Gleason score of 7)
- cN0 and cM0 stage
- Age \> 18 years
- Good performance status (ECOG\< 2),
- No previous pelvic radiotherapy
- No previous prostatectomy
- No hormonal treatment (neoadjuvant or concomitant)
- No concomitant bowel inflammatory disease or other serious comorbidities
- Good urinary flow (peak flow \> 10 ml/s)
- No previous invasive cancer (within 5 years before the prostate cancer diagnosis) apart from non-melanoma skin malignancies.
Exclusion
- Extraprostatic tumor extension (T3) or locally advanced disease (T4)
- Pelvic lymph node metastasis (N1)
- Distant metastasis (M1)
- Urinary obstructive symptoms (IPSS \> 20)
- Previous pelvic radiotherapy
- Severe systemic disorders
- Concomitant disorders including: chronic urinary or intestinal inflammatory conditions (for example, ulcerous recto-colitis, Crohn disease), anti-coagulant treatment (warfarin, heparin)
- Previous malignancy except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like in situ cervix cancer or non muscle invasive bladder cancer
- Non conformity of the radiotherapy dose distribution when compared to the dose constraints
- Psychiatric disorders or any other condition that can can make unreliable the informed consent
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01913717
Start Date
January 1 2014
End Date
July 1 2023
Last Update
June 28 2023
Active Locations (1)
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1
European Institute of Oncology
Milan, Italy