"APalutamide and stEReotactic body radiation therapy for low burden metastatic hormone senSItive prostate cancer, a rANdomized trial -PERSIAN".
Key facts
- Where
- Alba, Arezzo, Bologna, Candiolo, Florence, Foggia, Frattamaggiore, Genoa, Macerata, Misterbianco, Modena, Padova, Parma, Perugia, Reggio Emilia, Rome, Siena, Turin és Udine, OlaszországSee the 22 sites
- Phase
- 2. fázis
Where in Olaszország
- Azienda Sanitaria Locale Cn2 Alba-BraAlba, OlaszországTaking people
- Azienda Sanitaria Usl Toscana Sud EstArezzo, OlaszországTaking people
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, OlaszországTaking people
- Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCSCandiolo, OlaszországTaking people
- Careggi University HospitalFlorence, OlaszországTaking people
- Azienda Ospedaliero Universitaria Ospedali RiunitiFoggia, OlaszországTaking people
- Azienda Sanitaria Locale Napoli 2 NordFrattamaggiore, OlaszországTaking people
- IRCCS Ospedale Policlinico San MartinoGenoa, OlaszországTaking people
- Ospedale Generale Provinciale Di MacerataMacerata, OlaszországTaking people
- Humanitas Istituto Clinico Catanese S.p.A.Misterbianco, OlaszországTaking people
- Azienda Ospedaliero - Universitaria di ModenaModena, OlaszországTaking people
- Istituto Oncologico VenetoPadova, OlaszországTaking people
- Azienda Ospedaliero Universitaria ParmaParma, OlaszországTaking people
- Università degli Studi di PerugiaPerugia, OlaszországTaking people
- Azienda USL IRCCS di Reggio EmiliaReggio Emilia, OlaszországTaking people
- Azienda Ospedaliera Policlinico Universitario Tor VergataRome, OlaszországTaking people
- Azienda Ospedaliero-Universitaria Sant AndreRome, OlaszországTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, OlaszországTaking people
- Sapienza University Of RomeRome, OlaszországTaking people
- Azienda Ospedaliera Universitaria SeneseSiena, OlaszországTaking people
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, OlaszországTaking people
- Azienda Sanitaria Universitaria Friuli CentraleUdine, OlaszországTaking people
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?
Trial details
- Who runs it
- Fondazione Radioterapia Oncologica Onlus
- Trial code
- EU 2022-501894-37-00
- Record updated
- 2026. október 22.
- Original description
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).Read full original descriptionShow less
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).
Inclusion: 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.
Exclusion: 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.