Trials / Completed
CompletedNCT02946008
Neoadjuvant Stereotactic Body Radiotherapy Prior to Radical Prostatectomy for High Risk Prostate Cancer
A Phase I Trial of Neoadjuvant Stereotactic Body Radiotherapy Prior to Radical Prostatectomy for High Risk Prostate Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- University of Michigan Rogel Cancer Center · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a single-arm prospective non-randomized, non-blinded trial to assess the safety of neoadjuvant stereotactic body radiation therapy (SBRT) before surgery in high risk prostate cancer patients. Radiation therapy will be delivered over 5 treatment sessions for approximately 1.5 weeks total.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Stereotactic Body Radiation Therapy | Delivered over 5 treatment sessions for approximately 1.5 weeks total. |
| PROCEDURE | Radical Prostatectomy | Open, laparoscopic, or robotic radical prostatectomy and pelvic lymph node dissection to remove the prostate, seminal vesicles, and pelvic lymph nodes. |
Timeline
- Start date
- 2017-03-27
- Primary completion
- 2018-04-10
- Completion
- 2019-07-12
- First posted
- 2016-10-26
- Last updated
- 2019-11-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02946008. Inclusion in this directory is not an endorsement.