Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Patricia Willisch Santamaría, MD PhD
CONTACT
Pablo Raña Díez
CONTACT
Lead
Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic
The objectives of this prospective, multicenter study are: * Primary: 1\. Biochemical relapse-free survival, defined as the time to biochemical relapse (nadir plus 2 ng/mL - Phoenix criteria). * Secondary: 1. Local relapse-free survival, defined as the time from treatment to local relapse confirmed by imaging (choline PET/MRI). 2. Analysis of acute and chronic toxicity (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5). 3. Assessment of patient quality of life before and after treatment to analyze the impact of local re-irradiation on daily life using the following questionnaires: International Prostate Symptom Score (IPSS), Functional Assessment of Cancer Therapy-Prostate (FACT-P), and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Prostate Module (EORTC QLQ-PR25). Primary outcome measure: Biochemical relapse-free survival, and analysis of toxicity and quality of life in patients treated with salvage brachytherapy following radical treatment. Study population, total number of subjects, and duration: Patients who received radical-intent radiotherapy as their initial treatment (brachytherapy alone, external beam radiotherapy, or external beam radiotherapy plus a brachytherapy boost) and were diagnosed with local recurrence via next-generation imaging techniques (choline PET/PSMA PET) and prior biopsy; these patients are scheduled to undergo salvage brachytherapy as part of routine clinical practice. A calculated sample size of 63 patients will be reached over a 2-year recruitment period. Follow-up will be conducted according to standard clinical practice every 6 months for the 4-year duration of the study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
