NCT05003752Active, not recruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 29 Jun 2021
- Start date
- 1 Aug 2021
- Primary completion date
- 31 Dec 2022
- Lead sponsor
- German Oncology Center, Cyprus
- Diseases
- Prostate cancer
- NCT number
- NCT05003752
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 40
- From 1 Aug 2021 to the primary completion date, 31 Dec 2022
- 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
- Prior pelvic radiotherapy
- Prior TURP
- MRI non compatible metal implants
- Any treatment with radiation therapy, chemotherapy, immunotherapy, biotherapy and/or hormonal therapy for the currently diagnosed prostate cancer prior to registration.
- History of non-prostate malignancy, apart from patients that have been disease-free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence.
Other illness
- Known autoimmune disorders (e.g. inflammatory bowel disease, lupus, scleroderma)
- Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
Other
- Histopathological confirmation or suspicion in conventional or molecular imaging of regional or distant metastases
- Pre-existing fistulae
- Contraindication for general and spinal anaesthesia
- Inability to be placed in lithotomy position
Who the study is looking for
- The patient must consent to be in the study and must have signed an approved consent form
- Age \> 18 years old.
- Life expectancy of at least five years, excluding his diagnosis of prostate cancer.
- Histopathologically proven primary adenocarcinoma of the prostate
- The patient must be registered within 180 days following the histopathological confirmation of the malignancy
- Prostate volume \< 80ml
- International Prostate Symptom Score (IPSS) \< 18
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Patients with a history of non-prostate malignancies are eligible if they have been disease-free for 5 or more years prior to enrolment, are deemed by their physician to be at low risk for recurrence and they did not need pelvic radiotherapy as part of their treatment. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| German Oncology Center Coordinator of this site? Confirm its status | Limassol | Cyprus | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.