2022-501894-37-00RecruitingPhase 2
"APalutamide and stEReotactic body radiation therapy for low burden metastatic hormone senSItive prostate cancer, a rANdomized trial -PERSIAN".
Source: EU CTIS (euclinicaltrials.eu) · Last updated 22 Oct 2026
Brief summary (registry, in English)
To compare the benefit, in terms of rate of complete biochemical response at 6 months from treatment start (PSA < 0.2 ng/ml), obtained adding stereotactic body radiotherapy on all sites of metastatic disease in patients affected by oligometastatic hormone sensitive prostate carcinoma, undergoing androgen deprivation therapy and Apalutamide. Study will compare patients undergoing standard systemic treatment alone, consisting of androgen deprivation therapy + Apalutamide (Arm A: Control) versus patients undergoing the same systemic treatment associated with stereotactic body radiotherapy on all sites of metastatic disease (Arm B: Treatment).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 4 Nov 2022
- Start date
- 2 Mar 2023
- Lead sponsor
- Fondazione Radioterapia Oncologica Onlus
- Diseases
- Prostate cancer
- EU CT number
- 2022-501894-37-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 180
- 22 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence of visceral disease
- De novo metastatic disease
- Any condition for which, in the opinion of the treating physician, SBRT should not be proposed or could be contraindicated
Other
- Any contraindication to the use of Apalutamide
Who the study is looking for
- Patients who have signed written informed consent
- Adult patients ≥ 18 years
- Oligometastatic hormone sensitive prostate cancer defined as presence of <= 5 non-visceral metastatic lesions
- All lesions must be amenable to SBRT in judgment of treating radiation oncologist
- Patients with metastatic recurrence after previous radical prostatectomy or definitive radiotherapy will be included in the trial, provided that radical approach on prostate is administered
- Androgen deprivation therapy (ADT) started <= 6 months before enrollment
- Patients should be eligible to Apalutamide treatment
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Sanitaria Locale Cn2 Alba-Bra | Alba | Italy | Recruiting |
| Azienda Sanitaria Usl Toscana Sud Est | Arezzo | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico | Bologna | Italy | Recruiting |
| Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS | Candiolo | Italy | Recruiting |
| Careggi University Hospital | Florence | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Ospedali Riuniti | Foggia | Italy | Recruiting |
| Azienda Sanitaria Locale Napoli 2 Nord | Frattamaggiore | Italy | Recruiting |
| IRCCS Ospedale Policlinico San Martino | Genoa | Italy | Recruiting |
| Ospedale Generale Provinciale Di Macerata | Macerata | Italy | Recruiting |
| Humanitas Istituto Clinico Catanese S.p.A. | Misterbianco | Italy | Recruiting |
| Azienda Ospedaliero - Universitaria di Modena | Modena | Italy | Recruiting |
| Istituto Oncologico Veneto | Padova | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Parma | Parma | Italy | Recruiting |
| Università degli Studi di Perugia | Perugia | Italy | Recruiting |
| Azienda USL IRCCS di Reggio Emilia | Reggio Emilia | Italy | Recruiting |
| Azienda Ospedaliera Policlinico Universitario Tor Vergata | Rome | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Italy | Recruiting |
| Sapienza University Of Rome | Rome | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Sant Andre | Rome | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Senese | Siena | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino | Turin | Italy | Recruiting |
| Azienda Sanitaria Universitaria Friuli Centrale | Udine | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.