CyberKnife Radiosurgery for Locally Recurrent Prostate CA
This study is currently recruiting participants.
Verified September 2011 by CyberKnife Centers of San Diego
Sponsor:
CyberKnife Centers of San Diego
Information provided by (Responsible Party):
Carlyn Tripp, CyberKnife Centers of San Diego
ClinicalTrials.gov Identifier:
NCT00851916
First received: February 25, 2009
Last updated: September 19, 2011
Last verified: September 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Recurrent Prostate Cancer |
Radiation: CyberKnife Radiosurgery |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | VIRTUAL HDR CYBERKNIFE RADIOSURGERY FOR LOCALLY RECURRENT PROSTATIC CARCINOMA: A PHASE II STUDY |
Resource links provided by NLM:
Further study details as provided by CyberKnife Centers of San Diego:
Primary Outcome Measures:
- Establish pattern of PSA decline [ Time Frame: Post CyberKnife Radiosurgery - 5 year f/up ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Quality of Life realitive to other commonly used radiation treatment methods for recurrent prostate cancer [ Time Frame: Post CyberKnife Radiosurgery/5 yr. f/up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | February 2009 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
CyberKnife Radiosurgery
Single arm study using CyberKnife radiosurgery to treat recurrent prostate cancer patients that have already received external beam radiotherapy.
|
Radiation: CyberKnife Radiosurgery
CyberKnife Radiosurgery
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00851916
Contacts
| Contact: Carlyn Tripp | 619-230-0400 ext 224 | ctripp@rmgmed.com |
Locations
| United States, California | |
| CybeKnife Centers of San Diego | Recruiting |
| San Diego, California, United States, 92024 | |
| Principal Investigator: Donald B. Fuller, M.D. | |
Sponsors and Collaborators
CyberKnife Centers of San Diego
Investigators
| Principal Investigator: | Donald B Fuller, M.D. | CyberKnife Centers of San Diego |
More Information
No publications provided
| Responsible Party: | Carlyn Tripp, Donald Fuller, M.D., CyberKnife Centers of San Diego |
| ClinicalTrials.gov Identifier: | NCT00851916 History of Changes |
| Other Study ID Numbers: | CK Recurrent Prostate SD |
| Study First Received: | February 25, 2009 |
| Last Updated: | September 19, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013