Stereotactic Body Radiotherapy for Organ Confined Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Stereotactic Body Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of adenocarcinoma of the prostate
- History/physical examination with digital rectal examination of the prostate within 60 days prior to registration
- Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason scores 2-7
- Clinical stage T1-2b (DRE) (AJCC 7th edition) within 90 days of registration
- PSA < 20 ng/mL within 60 days prior to registration. PSA should not be obtained within 10 days after prostate biopsy. (Every effort should be made to obtain all serum PSA values obtained in the 1 year prior to treatment to allow for calculation of PSA kinetics.)
- Not more than one intermediate risk factor (T2b/GS7/PSA 10-20)
- Zubrod Performance Status 0-1 within 60 days prior to registration
- Age ≥ 21
- Patient must be able to provide study-specific informed consent prior to study entry.
- Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
Exclusion Criteria:
- Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (For example, carcinoma of the oral cavity is permissible; however, patients with prior history of bladder cancer are not allowed)
- T-stage ≥ T2c on staging MRI
- Evidence of distant metastases
- Regional lymph node involvement
- Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer
- Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
- Previous hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide) or LHRH antagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or surgical castration (orchiectomy)
- Use of finasteride within 30 days prior to registration. PSA should not be obtained prior to 30 days after stopping finasteride.
- Use of dutasteride within 90 days prior to registration. PSA should not be obtained prior to 90 days after stopping dutasteride.
- Previous or concurrent cytotoxic chemotherapy for prostate cancer
Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol. (Patients on Coumadin or other blood thinning agents are eligible for this study.)
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
Sites / Locations
- National Cancer Centre SingaporeRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stereotactic Body Radiotherapy
Arm Description
An extreme hypofractionated regimen of 36.25Gy in 5 fractions over 10-11 days
Outcomes
Primary Outcome Measures
The rate of late severe GI and GU toxicities
Secondary Outcome Measures
The rate of late severe GI and GU toxicities
The rate of acute severe GI and GU toxicities
PSA failure-free survival
Disease-free survival (DFS)
Time to local progression
Time to distant and/or regional failure
Disease-specific survival
Freedom from biochemical recurrence (FFBR)
Overall survival (OS)
The change in quality of life outcomes from baseline
Full Information
NCT ID
NCT02313298
First Posted
December 7, 2014
Last Updated
March 27, 2018
Sponsor
National Cancer Centre, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT02313298
Brief Title
Stereotactic Body Radiotherapy for Organ Confined Prostate Cancer
Official Title
A Phase II Trial of Prostate Stereotactic Radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Centre, Singapore
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A single arm phase II study of SBRT for prostate cancer to primarily assess acute and late toxicity and secondarily PSA outcomes and quality of life measurements of an extreme hypofractionated regimen of 36.25Gy in 5 fractions over 10-11 days.
Detailed Description
This is a single arm phase II study of SBRT for prostate cancer to primarily assess acute and late toxicity and secondarily PSA outcomes and quality of life measurements of an extreme hypofractionated regimen of 36.25Gy in 5 fractions over 10-11 days. The radiation therapy is to be delivered using intensity modulated radiotherapy (IMRT) with the aid of volumetric image guidance to ensure accuracy. Toxicity will be measured at preset intervals, as will HRQOL parameters using the Expanded Prostate Index Composite (EPIC) questionaire which focuses on bowel, urinary, sexual and hormonal symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stereotactic Body Radiotherapy
Arm Type
Experimental
Arm Description
An extreme hypofractionated regimen of 36.25Gy in 5 fractions over 10-11 days
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiotherapy
Intervention Description
IMRT or similar techniques that use inverse treatment planning
Primary Outcome Measure Information:
Title
The rate of late severe GI and GU toxicities
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The rate of late severe GI and GU toxicities
Time Frame
1 and 5 years
Title
The rate of acute severe GI and GU toxicities
Time Frame
1, 2 and 5 years
Title
PSA failure-free survival
Time Frame
1, 2 and 5 years
Title
Disease-free survival (DFS)
Time Frame
1, 2 and 5 years
Title
Time to local progression
Time Frame
1, 2 and 5 years
Title
Time to distant and/or regional failure
Time Frame
1, 2 and 5 years
Title
Disease-specific survival
Time Frame
1, 2 and 5 years
Title
Freedom from biochemical recurrence (FFBR)
Time Frame
1, 2 and 5 years
Title
Overall survival (OS)
Time Frame
1, 2 and 5 years
Title
The change in quality of life outcomes from baseline
Time Frame
1, 2 and 5 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diagnosis of adenocarcinoma of the prostate
History/physical examination with digital rectal examination of the prostate within 60 days prior to registration
Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason scores 2-7
Clinical stage T1-2b (DRE) (AJCC 7th edition) within 90 days of registration
PSA < 20 ng/mL within 60 days prior to registration. PSA should not be obtained within 10 days after prostate biopsy. (Every effort should be made to obtain all serum PSA values obtained in the 1 year prior to treatment to allow for calculation of PSA kinetics.)
Not more than one intermediate risk factor (T2b/GS7/PSA 10-20)
Zubrod Performance Status 0-1 within 60 days prior to registration
Age ≥ 21
Patient must be able to provide study-specific informed consent prior to study entry.
Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
Exclusion Criteria:
Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (For example, carcinoma of the oral cavity is permissible; however, patients with prior history of bladder cancer are not allowed)
T-stage ≥ T2c on staging MRI
Evidence of distant metastases
Regional lymph node involvement
Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer
Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
Previous hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide) or LHRH antagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or surgical castration (orchiectomy)
Use of finasteride within 30 days prior to registration. PSA should not be obtained prior to 30 days after stopping finasteride.
Use of dutasteride within 90 days prior to registration. PSA should not be obtained prior to 90 days after stopping dutasteride.
Previous or concurrent cytotoxic chemotherapy for prostate cancer
Severe, active co-morbidity, defined as follows:
Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
Transmural myocardial infarction within the last 6 months
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol. (Patients on Coumadin or other blood thinning agents are eligible for this study.)
Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan YH Teh
Phone
63214204
Email
jonathan.Teh.Y.H@nccs.com.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Sheena XF Tan
Phone
63214204
Email
Sheena.Tan.X.F@nccs.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melvin LK Chua
Organizational Affiliation
National Cancer Centre, Singapore
Official's Role
Study Director
Facility Information:
Facility Name
National Cancer Centre Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Stereotactic Body Radiotherapy for Organ Confined Prostate Cancer
We'll reach out to this number within 24 hrs