Comparing radioablation with and without hormone therapy for prostate cancer
Radioablation +/- Hormonotherapy for Prostate Cancer Oligorecurrences (RADIOSA Trial): Potential of Imaging and Biology
PHASE2 · European Institute of Oncology · NCT03940235
This study is testing whether adding hormone therapy to radiation treatment helps men with prostate cancer live longer and feel better compared to radiation alone.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | European Institute of Oncology (other) |
| Locations | 1 site (Milan, MI - Milano) |
| Trial ID | NCT03940235 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of stereotactic body radiotherapy (SBRT) alone versus SBRT combined with androgen deprivation therapy (ADT) in patients with oligometastatic prostate cancer. The primary objective is to compare progression-free survival (PFS) between the two treatment arms, while secondary endpoints include overall survival, biochemical progression-free survival, and quality of life assessments. The study also involves the collection of biological samples for future research on predictive and diagnostic factors related to treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include men aged 18 and older with histologically confirmed adenocarcinoma of the prostate and specific oligometastatic conditions.
Not a fit: Patients with serious comorbidities or contraindications to SBRT or ADT, as well as those with previous invasive cancers within the last three years, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment strategy for patients with oligometastatic prostate cancer, potentially improving their survival and quality of life.
How similar studies have performed: Other studies have shown promise in using SBRT for oligometastatic prostate cancer, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically proven initial diagnosis of adenocarcinoma of the prostate; * Biochemical relapse of PCa following radical local prostate treatment (radical prostatectomy, primary radiotherapy or radical prostatectomy +/- prostate bed adjuvant/salvage radiotherapy) +/- ADT according to the European Association of Urology (EAU) guidelines 2016 \[18\] or after any salvage therapy if biochemical progression is diagnosed in the context of castration sensitive PCa; * Nodal relapse in the pelvis, extra-regional nodal relapse (M1a), bone metastases (M1b) on Ch-PET/CT or WBMRI with a maximum of 3 lesions; * Serum testosterone level \>50 ng/dl at the time of randomization (castration sensitive PCa) * Eastern Cooperative Oncology Group (ECOG) performance status 0-1; * Age ≥18 years; * Written informed consent signed Exclusion criteria * Serious concomitant comorbidities or contraindication to SBRT and/or ADT; * Previous invasive cancer (within 3 years before the prostate cancer diagnosis) apart from non-melanoma skin malignancies; * No ability to complete questionnaires about QoL; * Presence of mental diseases that cannot ensure valid informed consent;
Where this trial is running
Milan, MI - Milano
- Istituto Europeo di Oncologia IRCCS — Milan, MI - Milano, Italy (RECRUITING)
Study contacts
- Study coordinator: Barbara A Jereczek-Fossa, Prof
- Email: barbara.jereczek@ieo.it
- Phone: +39 0257489037
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Oligometastatic Prostate Cancer