Trials / Active Not Recruiting
Active Not RecruitingNCT05003752
Hypo-Combi Trial: Hypofractionated EBRT Plus HDR-BT Boost for Prostate Cancer
Hypo-Combi Trial: Combined Hypofractionated External Beam Radiation Therapy (EBRT) Plus Interstitial High-Dose-Rate Brachytherapy (HDR-BT) Boost for Intermediate/High Risk Prostate Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- German Oncology Center, Cyprus · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Hypo-Combi Trial: A Prospective Phase I/II Study of Combined Hypofractionated External Beam Radiation Therapy (EBRT) plus Interstitial High-Dose-Rate Brachytherapy (HDR-BT) for Intermediate/High Risk Prostate Cancer
Detailed description
The Phase I/II trial will prospectively assess the acute, early late and late gastrointestinal (GI), genitourinary (GU) and sexual toxicity of combined hypofractionated external beam radiation therapy (EBRT) plus high dose-rate brachytherapy (HDR-BT) schedule (total dose of EBRT 36 Gy/ in 12 fractions of 3 Gy plus HDR-BT with a total physical dose of 14 Gy in a single fraction) for patients with unfavourable intermediate/high risk (based on NCCN stratification guidelines) organ-confined prostate cancer, not requiring pelvic irradiation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | External beam radiation therapy, High-dose-rate brachytherapy | Combined hypofractionated external beam radiation therapy (EBRT) plus high dose-rate brachytherapy (HDR-BT) schedule (total dose of EBRT 36 Gy/ in 12 fractions of 3 Gy plus HDR-BT with a total physical dose of 14 Gy in a single fraction) |
| DRUG | Goserelin 10.8 mg | Androgen deprivation will be administered based on NCCN guidelines in patients with unfavorable intermediate/high risk organ-confined prostate cancer |
Timeline
- Start date
- 2021-08-01
- Primary completion
- 2022-12-31
- Completion
- 2026-08-01
- First posted
- 2021-08-12
- Last updated
- 2023-03-07
Locations
1 site across 1 country: Cyprus
Source: ClinicalTrials.gov record NCT05003752. Inclusion in this directory is not an endorsement.