NCT03822494Active, not recruiting
CyberKnife Dose Escalation Prostate Cancer Trial
CyberKnife Dose Escalation for Unfavorable and High-risk Prostate Cancer
Source: ClinicalTrials.gov · Last updated 21 Feb 2025
Brief summary (registry, in English)
Stereotactic body radiation therapy (SBRT) has been employed in the treatment of prostate cancer. Multiple single institution experiences suggest high biochemical control rates with acceptable toxicity in low risk prostate cancer but efficacy data in unfavorable type prostate cancer is less convincing. CyberKnife-SBRT (CK-SBRT) can be used to escalate radiation dose delivery to the prostate while sparing normal tissue.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 28 Jan 2019
- Start date
- 12 Jul 2018
- Primary completion date
- 21 Jun 2023
- Lead sponsor
- Crozer-Keystone Health System
- Diseases
- Prostate cancer
- NCT number
- NCT03822494
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 12 Jul 2018 to the primary completion date, 21 Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication to hormone therapy
Other illness
- Other cancer diagnosis other than non-melanoma skin cancer with 5 years
- Metastatic prostate cancer
Other
- Prostate size greater than 100cc
- AUA greater than 20
- Implanted hardware impacting imaging
Who the study is looking for
- Histologically confirmed adenocarcinoma of the prostate diagnosed within 360 days of enrollment.
- Prostate Specific Antigen (PSA) documented within 90 days prior to registration.
- Clinical staging completed within 90 days of registration.
- No Nodal or Distant Metastases documented on CT or MRI of the pelvis and bone scan.
- Unfavorable Risk Prostate Carcinoma as Described is documented.
- No prior pelvic radiotherapy.
- No prior Trans-urethral resection of the prostate (TURP).
- Prostate volume \< 100 cc
- American Urologic Association (AUA) score \< 20
- No recent (within 5 years) or concurrent cancers other than non-melanoma skin cancers.
- Patient must have no medical or psychiatric illnesses that would interfere with treatment or follow-up.
- No implanted hardware adjacent to the prostate that would prohibit appropriate treatment planning and treatment delivery is allowed.
- Candidate for rectal spacer placement
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Philadelphia CyberKnife Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.