Trials / Completed
CompletedNCT02339948
Phase II Trial of SBRT + or - IMRT in Treatment of Patients With Clinically Confined Prostate Adenocarcinoma
A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) With or Without Intensity Modulated Radiation Therapy (IMRT) in the Treatment of Patients With Clinically Confined Prostate Adenocarcinoma
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 279 (actual)
- Sponsor
- GenesisCare USA · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Patients with locally confined prostate adenocarcinoma (clinical stage T1c - T2bN0M0, Gleason score 7, PSA 20 ng/ml) are assigned to one of two treatment arms. Low risk patients (T1c-T2a and PSA \<10 ng/ml and Gleason Score 6 or less) will receive 5 fractions of 8.0 Gy for a total of 40 Gy. Intermediate risk patients (T2b or PSA \>10 ng/ml orGleason Score 7) will receive 1.8 Gy of IMRT for 25 fractions over 5 weeks for a total of 45 Gy. They will then receive a boost consisting of 4, 5.5 Gy fractions after IMRT for a total of 22 Gy.
Detailed description
Patients with locally confined prostate adenocarcinoma (clinical stage T1c - T2bN0M0, Gleason score 7, PSA 20 ng/ml) are assigned to one of two treatment arms. Low risk patients (T1c-T2a and PSA \<10 ng/ml and Gleason Score 6 or less) will receive 5 fractions of 8.0 Gy for a total of 40 Gy. Intermediate risk patients (T2b or PSA \>10 ng/ml orGleason Score 7) will receive 1.8 Gy of IMRT for 25 fractions over 5 weeks for a total of 45 Gy. They will then receive a boost consisting of 4, 5.5 Gy fractions after IMRT for a total of 22 Gy. All patients will be assessed for toxicity at periodic time points following completion of treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | SBRT | 8.0 Gy per fraction for 5 fractions for a total of 40 Gy |
Timeline
- Start date
- 2006-06-01
- Primary completion
- 2019-10-01
- Completion
- 2019-10-01
- First posted
- 2015-01-16
- Last updated
- 2020-01-13
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02339948. Inclusion in this directory is not an endorsement.