Ignite Creation Date:
2024-05-06 @ 3:25 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02283346
Status:
UNKNOWN
Last Update Posted:
2014-11-05
First Post:
2014-11-03
Brief Title:
Single Fraction HDR Brachytherapy Plus Hypofractionated EBRT for Low-risk Prostate Cancer Phase II Trial
Sponsor:
AC Camargo Cancer Center
Organization:
AC Camargo Cancer Center
Study Overview
Official Title:
Single Fraction High Dose Rate HDR Brachytherapy Plus Hypofractionated External Beam Radiotherapy EBRT for Low-risk Prostate Cancer Phase II Trial
Status:
UNKNOWN
Status Verified Date:
2014-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AC-P01
Brief Summary:
The hypofractionated external radiation EBRT is a technique that radiation dose delivery using higher daily fractions than those used routinely In this way can cause more damage tumor especially in tissues that have a slower proliferation rate as in the case of prostate cancer Furthermore achieves a reduction in total treatment time and probably a lesser chance of development of collateral in tissues of high multiplication rate as the lining of the rectum and bladder effects
With brachytherapy boost for high dose rate is achieved by administering a more intense dose on the tumor and lower the sound around the region to be treated tissues improving the therapeutic window
Treatment with retracted and fully ambulatory time has potential benefit as early patient return to usual activities and optimizing the flow of patients who require treatment with radiotherapy This prospective study aims to assess the results and the toxicity profile of this treatment regimen retracted
With brachytherapy boost for high dose rate is achieved by administering a more intense dose on the tumor and lower the sound around the region to be treated tissues improving the therapeutic window
Treatment with retracted and fully ambulatory time has potential benefit as early patient return to usual activities and optimizing the flow of patients who require treatment with radiotherapy This prospective study aims to assess the results and the toxicity profile of this treatment regimen retracted
Detailed Description:
OBJECTIVE The primary objective is to analyze the toxicity profile via a phase II study of treatment of patients with low risk prostate cancer with the association of hypo fractionated EBRT and HDR brachytherapy boost
It will also analyze the biochemical control and expense to the procedure
STUDY DESIGN Prospective phase II study and not randomized Patients with localized low-risk prostate cancer will be recruited to participate in protocol hypofractionated external beam radiotherapy followed by brachytherapy high dose rate
INCLUSION CRITERIA
Biopsy confirming adenocarcinoma of the prostate
Low risk prostate cancer less than or equal T2a and less than or equal to 10 ng PSA ml stage and Gleason score less than or equal to 6
Prostate volume less than or equal to 60cc
EXCLUSION CRITERIA
Patients under 18 or over 90 years
Adjuvant Hormone any duration
Prior pelvic radiotherapy
Adjuvant Chemotherapy
OUTCOMES
Primary outcomes
Reduction of rectal acute morbidity within three months of treatment and late after three months to twelve months from the last treatment recruited patient
Reduction of acute urinary morbidity within three months of treatment and late after three months to twelve months from the last treatment recruited patient
The primary outcomes toxicity will be evaluated in patients who receive more than 90 of the intended dose protocol with crte and HDR brachytherapy
Scale used CTCAE v403 Published online May 282009 by the United States Department of Health and Human Services - NIH - attached
Secondary outcomes
Biochemical control serial PSA measurements at intervals of three months in the first year four months in the second year six months of the third year onwards
Cost-analysis procedure
STAGING
Performing the following tests
1 Physical examination - rectal TR
2 transrectal US TRUS
3 pelvic CT
4 serum prostatic specific antigen PSA dosage
5 Bone Scan
ETHICAL ASPECTS The treatment regimen will be monitored for the possible emergence of excessive toxicity considering that the same appearance in more than 25 of cases will be cause for termination of the protocol
The study will begin after approval by the Research Ethics Committee CEP of the AC Camargo Cancer Center Each patient will sign a term of informed consent IC prior to study entry The term was written in accessible laymans language the patient following the ethical recommendations Patients may withdraw from the study at any time without prejudice to the proposed treatment We declare the confidentiality of personally identifiable patient it is not possible to identify it during analysis and publication of data
It will also analyze the biochemical control and expense to the procedure
STUDY DESIGN Prospective phase II study and not randomized Patients with localized low-risk prostate cancer will be recruited to participate in protocol hypofractionated external beam radiotherapy followed by brachytherapy high dose rate
INCLUSION CRITERIA
Biopsy confirming adenocarcinoma of the prostate
Low risk prostate cancer less than or equal T2a and less than or equal to 10 ng PSA ml stage and Gleason score less than or equal to 6
Prostate volume less than or equal to 60cc
EXCLUSION CRITERIA
Patients under 18 or over 90 years
Adjuvant Hormone any duration
Prior pelvic radiotherapy
Adjuvant Chemotherapy
OUTCOMES
Primary outcomes
Reduction of rectal acute morbidity within three months of treatment and late after three months to twelve months from the last treatment recruited patient
Reduction of acute urinary morbidity within three months of treatment and late after three months to twelve months from the last treatment recruited patient
The primary outcomes toxicity will be evaluated in patients who receive more than 90 of the intended dose protocol with crte and HDR brachytherapy
Scale used CTCAE v403 Published online May 282009 by the United States Department of Health and Human Services - NIH - attached
Secondary outcomes
Biochemical control serial PSA measurements at intervals of three months in the first year four months in the second year six months of the third year onwards
Cost-analysis procedure
STAGING
Performing the following tests
1 Physical examination - rectal TR
2 transrectal US TRUS
3 pelvic CT
4 serum prostatic specific antigen PSA dosage
5 Bone Scan
ETHICAL ASPECTS The treatment regimen will be monitored for the possible emergence of excessive toxicity considering that the same appearance in more than 25 of cases will be cause for termination of the protocol
The study will begin after approval by the Research Ethics Committee CEP of the AC Camargo Cancer Center Each patient will sign a term of informed consent IC prior to study entry The term was written in accessible laymans language the patient following the ethical recommendations Patients may withdraw from the study at any time without prejudice to the proposed treatment We declare the confidentiality of personally identifiable patient it is not possible to identify it during analysis and publication of data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None