Status:
UNKNOWN
HDR Brachytherapy Plus Stereotactic Ablative Prostate Radiotherapy for Patients With Intermediate and High-risk Prostate Cancer
Lead Sponsor:
David Büchser
Conditions:
Prostatic Neoplasm
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
Dose escalation is nowadays a standard strategy in radiotherapy for prostate cancer. Besides, it is believed that due to the radiobiology characteristics of prostate cells (low alpha/beta ratio), the ...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of adenocarcinoma of the prostate.
- Intermediate or high-risk disease (as per NCCN criteria):
- Intermediate risk:
- Clinical stage ≤ T2c
- Gleason score 7 and initial PSA ≤ 20 ng/ml.
- Gleason score ≤ 6 and initial PSA \> 10 and ≤ 20 ng/ml.
- High risk,at least one of the following:
- Clinical stage T3a-b.
- Gleason score 8-10.
- Initial PSA \> 20 ng/ml.
- Life expectancy of more than 10 years
- Able and willing to complete Expanded Prostate Index Composite (EPIC) end EORTC questionnaires
- Eastern Cooperative Oncology Group (ECOG) of 0 - 2.
- Willing to give informed consent to participate in this clinical trial
- Give competent informed consent to participate in this trial.
Exclusion
- Documented nodal or distant metastases.
- Previous pelvic radiotherapy.
- Clinical stage T4.
- Clinical stage T3a or T3b in which the coverture of the extraprostatic disease is not feasible (as deemed by the treating physician).
- Prostate volume \> 70 cc (measured on MRI).
- Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) \>17
- Contra-indication to radical prostate radiotherapy
- Significant medical co-morbidity rendering patient unsuitable for general anaesthetic
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04523896
Start Date
July 1 2019
End Date
July 1 2023
Last Update
August 24 2020
Active Locations (1)
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1
Biocruces Bizkaia Health Research Institute/Cruces University Hospital
Barakaldo, Bizkaia, Spain, 48903