Status:
ENROLLING_BY_INVITATION
Moderately Hypofractionated Radiotherapy for Prostate Cancer.
Lead Sponsor:
Tatarstan Cancer Center
Conditions:
Prostatic Neoplasms
Genital Neoplasms
Eligibility:
MALE
18-100 years
Phase:
PHASE2
Brief Summary
Radiation therapy is one of the standard treatments for men with prostate cancer. Moderately hypofractionated radiotherapy has been established to be equivalent to standard fractionated radiotherapy i...
Detailed Description
OBJECTIVES: Primary Compare the biochemical relapse free survival (DFS) of patients with prostate cancer treated with hypofractionated regimens 70 Gy in 28 fractions and 60 Gy in 20 fractions intens...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 1\. Histologically confirmed adenocarcinoma of the prostate. 2 The presence of the following studies: TRUS of the prostate gland, pelvis MRI, OSG.
- 3 Histological evaluation of prostate biopsy with assignment of the Gleason index.
- 4 Clinical stage T1-3N0M0 (AJCC 7th edition). 5 ECOG performance status 0-1 6 Age limit 18 years. 7 Patient consent to participate in a clinical study.
- Exclusion criteria:
- Prior or concurrent lymphomatous/hematogenous malignancy or other invasive malignancy except nonmelanomatous skin cancer or any other cancer for which the patient has been continually disease-free for ≥ 5 years (e.g., carcinoma in situ of the bladder or oral cavity)
- Distatnt metastases.
- Metastases in the lymph nodes of prostate cancer.
- Radical prostatectomy or cryodestruction of the prostate gland in history.
- Radiation of a small pelvis in the anamnesis. Bilateral orchectomy history.
- Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months, transmural myocardial infarction within the past 6 months, acute bacterial or fungal infection requiring IV antibiotics, chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study treatment, hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
Exclusion
Key Trial Info
Start Date :
January 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2030
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03827616
Start Date
January 25 2019
End Date
February 1 2030
Last Update
February 12 2019
Active Locations (1)
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1
Tatarstan Cancer Cente
Kazan', Tatarstan Republic, Russia, 420029