Single Fraction HDR Brachytherapy Plus Hypofractionated EBRT for Low-risk Prostate Cancer: Phase II Trial (AC-P01)
Primary Purpose
Prostatic Neoplasms
Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
HDR brachytherapy + hypofractionated EBRT
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Prostate Cancer, HDR brachytherapy, hypo fractionated external beam radiotherapy, toxicity, biochemical control
Eligibility Criteria
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
Sites / Locations
- AC Camargo Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HDR Brachytherapy + EBRT
Arm Description
HDR brachytherapy + hypofractionated EBRT
Outcomes
Primary Outcome Measures
Acute and Late rectal and urinary morbidity
toxicity associated with the rectum and urinary tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)
Secondary Outcome Measures
biochemical control
serum PSA increase (2.0ng/ml above the nadir)
costs analysis of the treatment
Full Information
NCT ID
NCT02283346
First Posted
November 3, 2014
Last Updated
November 4, 2014
Sponsor
AC Camargo Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT02283346
Brief Title
Single Fraction HDR Brachytherapy Plus Hypofractionated EBRT for Low-risk Prostate Cancer: Phase II Trial
Acronym
AC-P01
Official Title
Single Fraction High Dose Rate (HDR) Brachytherapy Plus Hypofractionated External Beam Radiotherapy (EBRT) for Low-risk Prostate Cancer: Phase II Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AC Camargo Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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 v4.03, Published online: May 28,2009 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:
Physical examination - rectal (TR)
transrectal US (TRUS)
pelvic CT
serum prostatic specific antigen (PSA) dosage
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 layman's 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Prostate Cancer, HDR brachytherapy, hypo fractionated external beam radiotherapy, toxicity, biochemical control
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HDR Brachytherapy + EBRT
Arm Type
Experimental
Arm Description
HDR brachytherapy + hypofractionated EBRT
Intervention Type
Radiation
Intervention Name(s)
HDR brachytherapy + hypofractionated EBRT
Intervention Description
Single Fraction High Dose Rate (HDR) Brachytherapy One fraction with 10-15 Gray (Gy) (depending on normal tissues constraints).
+ Hypofractionated External Beam Radiotherapy (EBRT) The treatment will be held with fractions 2.5 Gy per day, with a final dose between 25 and 50 Gy (depending on normal tissues constraints).
Primary Outcome Measure Information:
Title
Acute and Late rectal and urinary morbidity
Description
toxicity associated with the rectum and urinary tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
biochemical control
Description
serum PSA increase (2.0ng/ml above the nadir)
Time Frame
3 years
Title
costs analysis of the treatment
Time Frame
one week after the treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucas G Sapienza, MD
Phone
+55(11)987612991
Email
lucasgsapienza@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucas G Sapienza, MD
Organizational Affiliation
AC Camargo Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
AC Camargo Cancer Center
City
São Paulo
State/Province
SP
ZIP/Postal Code
01509-010
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Single Fraction HDR Brachytherapy Plus Hypofractionated EBRT for Low-risk Prostate Cancer: Phase II Trial
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