Taking people in ItalyPhase 2
Tests radiation added to apalutamide and hormone therapy in prostate cancer
Tests stereotactic body radiation added to hormone therapy in men with metastatic prostate cancer.
Key facts
- Who runs it
- Fondazione Radioterapia Oncologica Onlus
- Where
- Alba, Arezzo, Bologna, Candiolo, Florence, Foggia, Frattamaggiore, Genoa, Macerata, Misterbianco, Modena, Padova, Parma, Perugia, Reggio Emilia, Rome, Siena, Turin, and Udine, ItalySee the 22 sites
- Trial code
- Registry title
- "APalutamide and stEReotactic body radiation therapy for low burden metastatic hormone senSItive prostate cancer, a rANdomized trial -PERSIAN".
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 180 people, planned
- Started
- 2 Mar 2023
- Planned end
- 1 Feb 2026
- Type of study
- Interventional
- Record updated
- 22 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer that still responds to hormone treatment and has spread to a few places (5 or fewer). It tests adding focused radiation to standard drug treatment.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Hormone-sensitive prostate cancer with 5 or fewer metastatic lesions, none in the organs (non-visceral). All lesions must be treatable with stereotactic body radiotherapy (SBRT). Spread that came back after earlier prostate surgery or radiotherapy is accepted if the prostate itself is also treated.
- Earlier treatment
- Androgen deprivation therapy (ADT) must have started 6 months or less before joining.
Main reasons for not taking part
- Cancer in the organs (visceral disease)
- Cancer that had already spread when first diagnosed (de novo metastatic disease)
- Any reason not to use Apalutamide
- Any reason the treating doctor thinks SBRT should not be given
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Any contraindication to the use of Apalutamide
Where in Italy
- Azienda Sanitaria Locale Cn2 Alba-BraAlba, ItalyTaking people
- Azienda Sanitaria Usl Toscana Sud EstArezzo, ItalyTaking people
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyTaking people
- Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCSCandiolo, ItalyTaking people
- Careggi University HospitalFlorence, ItalyTaking people
- Azienda Ospedaliero Universitaria Ospedali RiunitiFoggia, ItalyTaking people
- Azienda Sanitaria Locale Napoli 2 NordFrattamaggiore, ItalyTaking people
- IRCCS Ospedale Policlinico San MartinoGenoa, ItalyTaking people
- Ospedale Generale Provinciale Di MacerataMacerata, ItalyTaking people
- Humanitas Istituto Clinico Catanese S.p.A.Misterbianco, ItalyTaking people
- Azienda Ospedaliero - Universitaria di ModenaModena, ItalyTaking people
- Istituto Oncologico VenetoPadova, ItalyTaking people
- Azienda Ospedaliero Universitaria ParmaParma, ItalyTaking people
- Università degli Studi di PerugiaPerugia, ItalyTaking people
- Azienda USL IRCCS di Reggio EmiliaReggio Emilia, ItalyTaking people
- Azienda Ospedaliera Policlinico Universitario Tor VergataRome, ItalyTaking people
- Azienda Ospedaliero-Universitaria Sant AndreRome, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
- Sapienza University Of RomeRome, ItalyTaking people
- Azienda Ospedaliera Universitaria SeneseSiena, ItalyTaking people
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyTaking people
- Azienda Sanitaria Universitaria Friuli CentraleUdine, ItalyTaking people
About the trial
What the trial wants to find out
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).
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- "APalutamide and stEReotactic body radiation therapy for low burden metastatic hormone senSItive prostate cancer, a rANdomized trial -PERSIAN".
- Plain-language title
- Tests radiation added to apalutamide and hormone therapy in prostate cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 22 October 2026