CyberKnife Radiosurgery for Locally Recurrent Prostate CA
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | February 2009 |
| Contact: | Carlyn Tripp |
| Email: | ctripp@rmgmed.com |
| Phone: | 619-230-0400 |
VIRTUAL HDR CYBERKNIFE RADIOSURGERY FOR LOCALLY RECURRENT PROSTATIC CARCINOMA: A PHASE II STUDY
The purpose of this study is to scientifically evaluate the effects (good and bad) of a new
type of radiation treatment in patients with locally recurrent prostate cancer after prior
radiotherapy. The treatment is known as prostate radiosurgery, and is distinguished from
traditional radiotherapy by the application of smaller, more precisely controlled margins
around the area targeted for full dose radiation, and far fewer treatments, using a much
larger dose per treatment.
This research is being done to see what advantages, if any, prostate radiosurgery may have
over other salvage treatment methods, including brachytherapy, cryosurgery, high intensity
focused ultrasound (HIFU), hormonal therapy and radical prostatectomy.
type of radiation treatment in patients with locally recurrent prostate cancer after prior
radiotherapy. The treatment is known as prostate radiosurgery, and is distinguished from
traditional radiotherapy by the application of smaller, more precisely controlled margins
around the area targeted for full dose radiation, and far fewer treatments, using a much
larger dose per treatment.
This research is being done to see what advantages, if any, prostate radiosurgery may have
over other salvage treatment methods, including brachytherapy, cryosurgery, high intensity
focused ultrasound (HIFU), hormonal therapy and radical prostatectomy.
Inclusion Criteria:
- Histologically confirmed recurrent adenocarcinoma of the prostate, clinical stage T1
- T3 (AJCC 6th Edition, see Appendix II), NX/N0, M0, following prior prostate
radiotherapy.
- Karnofsky performance status >80.
- Greater than 5 year life expectancy
- Greater than 2 years since the original course of radiotherapy.
- Absence of distant metastases by radiologic or pathologic assessment.
- Absence of lymph node involvement by radiologic or pathologic assessment.
- Patients must sign a study-specific informed consent form prior to study entry.
Exclusion Criteria:
- Stage T4 disease (AJCC 6th Edition, see Appendix II).
- Less than 2 years since the original course of radiotherapy.
- Lymph node involvement (N1).
- Evidence of distant metastases (M1).
- Radical surgery for carcinoma of the prostate
- Previous or concurrent cancers other than basal, in situ, or squamous cell skin
cancers unless disease-free for ≥ 5 years.
- Major medical or psychiatric illness, which in the investigator's opinion, would
prevent completion of treatment and would interfere with follow-up.
- History of inflammatory bowel disease
- Late GI or GU Morbidity > Grade 1 from the prior course of radiotherapy
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