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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02283346 |
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Date of registration:
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03/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Single Fraction HDR Brachytherapy Plus Hypofractionated EBRT for Low-risk Prostate Cancer: Phase II Trial
AC-P01 |
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Scientific title:
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Single Fraction High Dose Rate (HDR) Brachytherapy Plus Hypofractionated External Beam Radiotherapy (EBRT) for Low-risk Prostate Cancer: Phase II Trial |
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Date of first enrolment:
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November 2014 |
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Target sample size:
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60 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02283346 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Lucas G Sapienza, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AC Camargo Cancer Center |
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Name:
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Lucas G Sapienza, MD |
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Address:
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Telephone:
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+55(11)987612991 |
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Email:
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lucasgsapienza@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Biopsy confirming adenocarcinoma of the prostate
- Low-risk Prostate Cancer: less than or equal T2a stage + PSA less than or equal to 10
ng/ml stage + Gleason score less than or equal to 6
- Prostate volume than or equal to 60cc
Exclusion Criteria:
- Adjuvant Hormone
- Prior pelvic radiotherapy
- Adjuvant Chemotherapy
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostatic Neoplasms
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Intervention(s)
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Radiation: HDR brachytherapy + hypofractionated EBRT
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Primary Outcome(s)
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Acute and Late rectal and urinary morbidity
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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biochemical control
[Time Frame: 3 years]
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costs analysis of the treatment
[Time Frame: one week after the treatment]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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