CyberKnife Radiosurgery for Localized Prostatic Carcinoma
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ClinicalTrials.gov Identifier: NCT01045148 |
Recruitment Status
:
Recruiting
First Posted
: January 8, 2010
Last Update Posted
: July 21, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Radiation: CyberKnife Radiosurgery | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 258 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Virtual HDR CyberKnife Radiosurgery for Localized Prostatic Carcinoma: A Phase II Study |
Study Start Date : | March 2006 |
Estimated Primary Completion Date : | December 2020 |

Arm | Intervention/treatment |
---|---|
CyberKnife Radiosurgery
CyberKnife Radiosurgery
|
Radiation: CyberKnife Radiosurgery
High Dose 3800 cGy/4 fractions
Radiation: CyberKnife Radiosurgery
Moderate Dose 3400 cGy/5 fractions
|
- To evaluate the effects of CK prostate radiosurgery in terms of morbidity/QOL, relative to other commonly used methods of prostate cancer treatment and the pattern of PSA decline and biochemical relapse-free survival thereafter. [ Time Frame: 5 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate, clinical stage T1b - T2b (AJCC 6th Edition, see Appendix II), NX/N0, M0.
- Karnofsky performance status > 80.
-
Patient must be ≥ 18 years of age.
- Gleason Sum < or = 7
- Prostate-specific antigen < or = 20 ng/ml
- Patients must sign a study-specific informed consent form prior to study entry.
Exclusion Criteria:
- Stage < T1b, T2c, T3 or T4 disease (AJCC 6th Edition, see Appendix II).
- Gleason Score > 7.
- PSA > 20 ng/ml.
- Lymph node involvement (N1).
- Evidence of distant metastases (M1).
- Radical surgery for carcinoma of the prostate, prior pelvic radiation, pelvic surgical clips or other metallic foreign bodies.
- History of hormonal therapy (antiandrogen or 5 alpha reductase treatment within three months prior to treatment).
- 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.
- Metallic Hip prosthesis.
- History of inflammatory bowel disease

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01045148
Contact: Carlyn A Tripp | 619-230-0400 ext 224 | ctripp@genhp.com |
United States, California | |
CyberKnife Centers of San Diego | Recruiting |
San Diego, California, United States, 92024 | |
Contact: Carlyn A Tripp 619-230-0400 ext 224 ctripp@genhp.com | |
Principal Investigator: Donald B Fuller, M.D. |
Principal Investigator: | Donald B Fuller, M.D. | CyberKnife Centers of San Diego/Radiation Medical Group- Genesis Healthcare Partners |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Carlyn Tripp, Donald Fuller, M.D., CyberKnife Centers of San Diego |
ClinicalTrials.gov Identifier: | NCT01045148 History of Changes |
Other Study ID Numbers: |
Virtual HDR CK Radiosurgery |
First Posted: | January 8, 2010 Key Record Dates |
Last Update Posted: | July 21, 2017 |
Last Verified: | July 2017 |
Keywords provided by Carlyn Tripp, CyberKnife Centers of San Diego:
Prostatic Cancer Prostatic Neoplasms Prostate Neoplasms Cancer of the Prostate |
Additional relevant MeSH terms:
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |