Evaluation of Truebeam for Low-Intermediate Risk Prostate Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2011 |
| End Date: | December 2022 |
| Contact: | Department of Radiation Oncology |
| Phone: | 484-476-3587 |
Prospective Evaluation of Truebeam STX Stereotactic Body Radiosurgery for Low and Intermediate Risk Prostate Cancer
The primary safety purpose of this study is to estimate the rates of immediate and long-term
high grade (grade 3-5) gastrointestinal and genitourinary side effects during the five years
after TrueBeam stereotactic body radiotherapy in low-risk and intermediate-risk prostate
cancer patients. The primary efficacy purpose is to compare 5 year biochemical disease free
survival rates with TrueBeam to 5 year biochemical diseases free survival rates with
dose-escalated external beam radiation therapy.
high grade (grade 3-5) gastrointestinal and genitourinary side effects during the five years
after TrueBeam stereotactic body radiotherapy in low-risk and intermediate-risk prostate
cancer patients. The primary efficacy purpose is to compare 5 year biochemical disease free
survival rates with TrueBeam to 5 year biochemical diseases free survival rates with
dose-escalated external beam radiation therapy.
The prescribed PTV dose of 36.25Gy shall be given in 5 fractions using the Truebeam STx.
At one week after treatment, toxicity and AUA score will be evaluated. At 1 month following
treatment, patients will be assessed for acute toxicity, and will fill out AUA form, SF-12,
EPIC-26, SHIM and Utilization of Sexual Rx/Devices. At 3, 6, 12, 18, and 24 month intervals
(and every 6 months thereafter, through year 5, and annually through year 10, if
investigators opt to continue past year 5), patients will be seen and evaluated, including a
history, physical exam, ECOG performance status, PSA, toxicity evaluation, and AUA score. In
addition, at 6 months, 12 months and annually thereafter, the SF-12, EPIC-26, SHIM and
Utilization of Sexual Medications/Devices will be administered. Examination and studies may
be done at outside facility.
A prostate biopsy will be performed at time of biochemical or local clinical failure, and is
encouraged at 2 years following treatment and at time of distant failure.
At one week after treatment, toxicity and AUA score will be evaluated. At 1 month following
treatment, patients will be assessed for acute toxicity, and will fill out AUA form, SF-12,
EPIC-26, SHIM and Utilization of Sexual Rx/Devices. At 3, 6, 12, 18, and 24 month intervals
(and every 6 months thereafter, through year 5, and annually through year 10, if
investigators opt to continue past year 5), patients will be seen and evaluated, including a
history, physical exam, ECOG performance status, PSA, toxicity evaluation, and AUA score. In
addition, at 6 months, 12 months and annually thereafter, the SF-12, EPIC-26, SHIM and
Utilization of Sexual Medications/Devices will be administered. Examination and studies may
be done at outside facility.
A prostate biopsy will be performed at time of biochemical or local clinical failure, and is
encouraged at 2 years following treatment and at time of distant failure.
Inclusion Criteria:
- histologically proven prostate adenocarcinoma within 1 year of enrollment
- Low risk: Gleason
- Intermediate risk:Gleason
Stage T1b- T2b, Nx or NO, Mx or M0
- ECOG Performance Status 0-1
- No prior prostate radiation or other definitive therapy
Exclusion Criteria:
- implanted hardware or other material that would prohibit treatment planning or
delivery
- chemotherapy for a malignancy within the previous 5 years
- history of an invasive malignancy (other than this prostate cancer,or basal or
squamous skin cancers) within prior 5 years
- hormone ablation for 2 months prior to treatment or during treatment
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