Evaluating CyberKnife for treating prostate cancer
Prospective Evaluation of Stereotactic Body Radiotherapy Boost for Unfavorable Localized Prostate Cancer
This study is testing if a new radiation treatment called CyberKnife can help men with prostate cancer feel better and have fewer side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | MemorialCare Health System Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Fountain Valley, California and 2 other locations) |
| Trial ID | NCT02016248 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and side effects of CyberKnife stereotactic ablative body radiation (SABR) in patients with prostate cancer. The CyberKnife system uses advanced technology to deliver high doses of radiation precisely to the tumor while minimizing damage to surrounding healthy tissue. The study aims to determine if this treatment can improve patient outcomes and assess its impact on quality of life over time. Patients with low to intermediate risk prostate cancer will be monitored for their response to this innovative treatment approach.
Who should consider this trial
Good fit: Ideal candidates for this study are men with histologically proven prostate adenocarcinoma who have not undergone prior prostatectomy or radiotherapy.
Not a fit: Patients with advanced prostate cancer or those who have had previous treatments such as prostatectomy or cryotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a more effective and less invasive option for patients with prostate cancer, potentially leading to quicker recovery times and improved quality of life.
How similar studies have performed: Other studies have shown promising results with similar stereotactic radiation approaches, indicating potential for success with this novel treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion * Histologically proven prostate adenocarcinoma * Biopsy within 12 months of date of registration required except for patients who already meet criteria for enrollment in the high risk arm of the protocol. For these patients, repeat biopsy will be at the discretion of the treating physician. In general, repeat biopsy is recommended for these patients, but is not required if it will not affect the treating physician's management decisions in regards to the care of the patient. * Clinical Stage I-IV, MX-M0 (AJCC VERSION 9) * M-stage determined by physical exam, CT, MRI, bone scan, PSMA PET/CT, or biopsy. * Prostate volume: ≤ 100 cc (recommended not required) * Determined using: volume = π/6 x length x height x width * Measurement from CT, MRI or ultrasound ≤ 90 days prior to registration. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * No prior prostatectomy or cryotherapy of the prostate * No prior radiotherapy to the prostate or lower pelvis * No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion. * Completion of patient questionnaires in section 3.7. * Consent signed Exclusion * No prior prostatectomy or cryotherapy of the prostate * No prior radiotherapy to the prostate or lower pelvis * No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
Where this trial is running
Fountain Valley, California and 2 other locations
- Orange Coast Memorial Medical Center — Fountain Valley, California, United States (Recruiting)
- Saddleback Memorial Medical Center — Laguna Hills, California, United States (Recruiting)
- Long Beach Memorial Medical Center — Long Beach, California, United States (Recruiting)
Study contacts
- Principal investigator: Asif Harsolia, MD — MemorialCare
- Study coordinator: Shelbe Tolentino (Santos)
- Email: stolentino2@memorialcare.org
- Phone: 562-933-9068
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.