"APalutamide and stEReotactic body radiation therapy for low burden metastatic hormone senSItive prostate cancer, a rANdomized trial -PERSIAN".

2022-501894-37-00 Protocol PERSIAN Therapeutic exploratory (Phase II) Ongoing, recruiting

Start 2 Mar 2023 · Status Ongoing, recruiting · 1 EU/EEA countries · 22 sites · Protocol PERSIAN

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ongoing, recruiting
Participants planned 180
Countries 1
Sites 22

prostate cancer

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 th…

Key facts

Sponsor
Fondazione Radioterapia Oncologica Onlus
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
2 Mar 2023 → ongoing
Decision date (initial)
2023-02-20
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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).

Secondary objectives 6

  1. Time to PSA progression according to Prostate Cancer Working Group (PCWG) criteria
  2. Radiologic progression free survival (rPFS) according to PCWG criteria
  3. Frequency of treatment emergent adverse events (AEs)
  4. Overall survival
  5. Cancer specific survival
  6. Quality of life measured with EORTC QLQ-C30 and EORTC QLQ-PR25

Conditions and MedDRA coding

prostate cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

  1. Patients who have signed written informed consent
  2. Adult patients ≥ 18 years
  3. Oligometastatic hormone sensitive prostate cancer defined as presence of <= 5 non-visceral metastatic lesions
  4. All lesions must be amenable to SBRT in judgment of treating radiation oncologist
  5. 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
  6. Androgen deprivation therapy (ADT) started <= 6 months before enrollment
  7. Patients should be eligible to Apalutamide treatment

Exclusion criteria 4

  1. Presence of visceral disease
  2. De novo metastatic disease
  3. Any contraindication to the use of Apalutamide
  4. Any condition for which, in the opinion of the treating physician, SBRT should not be proposed or could be contraindicated

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Rate of patients with complete biochemical response (PSA < 0.2 ng/ml) at 6 months after treatment start

Secondary endpoints 6

  1. Freedom from biochemical progression according to Prostate Cancer Working Group Criteria
  2. Freedom from radiological progression according to Prostate Cancer Working Group Criteria
  3. Rate of adverse events, measured according to Common Terminology Criteria for Adverse Events
  4. Overall Survival
  5. Cancer Specific Survival
  6. Health related quality of life measured with EORTC QLQ-C30 and QLQ-PR25 questionnaires

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Apalutamide

SUB189031 · Substance

Active substance
Apalutamide
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
240 mg milligram(s)
Max total dose
240 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fondazione Radioterapia Oncologica Onlus

3 Total trials 2 Recruiting
Academic / Non-commercial
Sponsor organisation
Fondazione Radioterapia Oncologica Onlus
Address
Via Adelmo Santini 3
City
Agliana
Postcode
51031
Country
Italy

Scientific contact point

Organisation
Fondazione Radioterapia Oncologica Onlus
Contact name
Lorenzo Livi

Public contact point

Organisation
Fondazione Radioterapia Oncologica Onlus
Contact name
Lorenzo Livi

Third parties 1

OrganisationCity, countryDuties
Advice Pharma Group S.r.l.
ORG-100046919
 Milan, Italy Other, Code 5, Data management, E-data capture

Locations

1 EU/EEA country · 22 investigational sites

By country

CountryMS statusPlanned subjectsSites
Italy Ongoing, recruiting 180 22
Rest of world — 0 —

Investigational sites

Italy

22 sites · Ongoing, recruiting
Azienda Sanitaria Locale Cn2 Alba-Bra
SC Oncologia, Via Vida 10, 12051, Alba
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
SC Radioterapia U, Corso Bramante 88, 10126, Turin
Azienda Sanitaria Locale Napoli 2 Nord
UOC Oncologia, Via Michelangelo Lupoli 27, 80027, Frattamaggiore
Sapienza University Of Rome
Dip. Scienze Radiologiche, Radioterapiche ed Oncologiche, Piazzale Aldo Moro 5, 00185, Rome
Azienda Ospedaliero Universitaria Parma
UOC Radioterapia, Viale Antonio Gramsci 14, 43126, Parma
Azienda Sanitaria Usl Toscana Sud Est
UOC Oncologia, Ospedale Area Aretina Nord, Via Pietro Nenni 20/22, Arezzo
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Radioterapia, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo
Universita' Degli Studi Di Perugia
Radioterapia Oncologica, Piazza Dell' Universita' 1, 06123, Perugia
Azienda Ospedaliero Universitaria Ospedali Riuniti
Oncologia Medica, Viale Luigi Pinto 1, 71122, Foggia
IRCCS Ospedale Policlinico San Martino
UO Oncologia Medica 1, Largo Rosanna Benzi 10, 16132, Genoa
Humanitas Istituto Clinico Catanese S.p.A.
Radioterapia, Contrada Cubba Sp54 11, 95045, Misterbianco
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Dipartimento Malattie Oncologiche ed Ematologiche, Via Pietro Albertoni 15, 40138, Bologna
Ospedale Generale Provinciale Di Macerata
UOC Oncologia, Via Santa Lucia 2, 62100, Macerata
Azienda Ospedaliero-Universitaria Sant Andre
Radioterapia, Via Di Grottarossa 1035-1039, 00189, Rome
Azienda Sanitaria Universitaria Friuli Centrale
Radioterapia, Via Pozzuolo 330, 33100, Udine
Azienda USL IRCCS Di Reggio Emilia
SC Radioterapia, Viale Umberto Primo 50, 42123, Reggio Emilia
Istituto Oncologico Veneto
Urologia Oncologica, Via Gattamelata 64, 35128, Padova
Careggi University Hospital
Radioterapia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Oncoematologia, UOC Radioterapia, Viale Oxford 81, 00133, Rome
Azienda Ospedaliero Universitaria Di Modena
Radioterapia Oncologica, Largo Del Pozzo 71, 41124, Modena
Azienda Ospedaliera Universitaria Senese
Radioterapia, Viale Mario Bracci 1, 53100, Siena
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Oncologia Medica, Largo Francesco Vito 1, 00168, Rome

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Italy 2023-03-02 2023-03-28

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Recruitment arrangements (for publication) 08 PERSIAN_RECRUITMENT_ARRANGEMENTS_V_1_20221028 1.0
Subject information and informed consent form (for publication) 10 PERSIAN_ICF_PREGNANCY_PARTNER_V_1_20221028 1.0
Subject information and informed consent form (for publication) 11 PERSIAN_ICF_GENETICS_V_1_20221028 1.0
Subject information and informed consent form (for publication) 12 PERSIAN_ICF_PRIVACY_V_1_20221028 2.0
Subject information and informed consent form (for publication) PERSIAN_EMERGENCY_CARD_ITA_V_1_20221018 1.0
Subject information and informed consent form (for publication) PERSIAN_EORTC QLQ-PR25_QUESTIONNAIRE 1
Subject information and informed consent form (for publication) PERSIAN_EORTC-QLQ-C30_QUESTIONNAIRE 1
Subject information and informed consent form (for publication) PERSIAN_GP_LETTER_V_1_20221028 1.0
Subject information and informed consent form (for publication) PERSIAN_INFORMED_CONSENT_FORM_V_3_20230112 3

Application history

6 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2022-11-04 Italy Acceptable
2023-02-06
 2023-02-20
2 SUBSTANTIAL MODIFICATION SM-1 2023-02-27 Italy Acceptable 2023-03-31
3 SUBSTANTIAL MODIFICATION SM-2 2023-05-17 Italy Acceptable 2023-06-09
4 SUBSTANTIAL MODIFICATION SM-3 2023-12-01 Italy Acceptable 2024-01-22
5 SUBSTANTIAL MODIFICATION SM-4 2024-09-18 Italy Acceptable 2024-10-30
6 NON SUBSTANTIAL MODIFICATION NSM-1 2025-05-05 Italy Acceptable 2025-05-05

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