Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
73
Countries
1
Sites
14
Intermediate risk prostate cancer
To assess rate of complete biochemical response after 6 months of treatment, defined as PSA <0.5 ng/ml, in an homogeneous cohort of patients affected by unfavourable intermediate risk localized prostate cancer undergoing prostate radiotherapy (36.25 GY in 5 fractions) + short course oral relugolix.
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]
- Decision date (initial)
- 2025-04-03
- 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 assess rate of complete biochemical response after 6 months of treatment, defined as PSA <0.5 ng/ml, in an homogeneous cohort of patients affected by unfavourable intermediate risk localized prostate cancer undergoing prostate radiotherapy (36.25 GY in 5 fractions) + short course oral relugolix.
Secondary objectives 6
- Biochemical relapse free survival (BRFS) at 2 years after end of radiotherapy. Biochemical relapse will be defined as a rise by 2 ng/mL or more above the nadir PSA according to RTOG- ASTRO Phoenix Consensus Conference [Roach 2006]
- Rate of patients with testosterone recovery at 90 days from the end of ADT treatment (eugonadal level of testosterone will be defined as >150 ng/dL)
- Rate of patients experiencing non pathological fracture at 2 years
- Rate of cardiovascular events at 48 weeks (myocardial infarction and stroke)
- Erectile disfunction rate measured with IIEF at 2 years after the end of treatment
- Quality of life measured with EORTC QLQ-C30 and EORTC QLQ-PR25
Conditions and MedDRA coding
Intermediate risk prostate cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- > 18 years old
- Signed informed consent
- Hystological confirmation of prostate adenocarcinoma
- Deemed suitable for ultrahypofractionated treatment on prostate (IPSS < 15, prostate volume <90 cc)
- Patients should be candidate to androgen deprivation therapy for the management of prostate cancer
- Unfavourable intermediate risk (GLeason 4+3 and or >50% of biopsy cores positive and or > 2 intermediate risk factor)
Exclusion criteria 7
- Neuroendocrine differentiation
- Metastatic disease at diagnosis (Patients will be staged with conventional imaging consisting of CT and/or bone scan and prostate MRI. PSMA imaging is allowed but not mandatory.)
- Any high-risk feature (Gleason >4+3, >cT3a, PSA > 20 ng/ml)
- Any contrahindication for ultrahypofractionated radiotherapy on prostate
- Participants with myocardial infarction, unstable symptomatic ischemic heart disease, cerebrovascular events, or any significant cardiac condition within the prior 6 months
- Active conduction system abnormalities
- Uncontrolled hypertension
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To assess rate of complete biochemical response after 6 months of treatment, defined as PSA <0.5 ng/ml, in an homogeneous cohort of patients affected by unfavourable intermediate risk localized prostate cancer undergoing prostate radiotherapy (36.25 GY in 5 fractions) + short course oral relugolix.
Secondary endpoints 6
- Biochemical relapse free survival (BRFS) at 2 years after end of radiotherapy. Biochemical relapse will be defined as a rise by 2 ng/mL or more above the nadir PSA according to RTOG- ASTRO Phoenix Consensus Conference [Roach 2006]
- Rate of patients with testosterone recovery at 90 days from the end of ADT treatment (eugonadal level of testosterone will be defined as >150 ng/dL)
- Rate of patients experiencing non pathological fracture at 2 years
- Rate of cardiovascular events at 48 weeks (myocardial infarction and stroke)
- Erectile disfunction rate measured with IIEF at 2 years after the end of treatment
- Quality of life measured with EORTC QLQ-C30 and EORTC QLQ-PR25
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP56468552 · ATC
- Active substance
- Relugolix
- Substance synonyms
- TAK-385
- Route of administration
- ORAL
- Max daily dose
- 360 mg milligram(s)
- Max total dose
- 360 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BX04 — RELUGOLIX
- 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
- 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
Locations
1 EU/EEA country · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Authorised, recruitment pending | 73 | 14 |
| Rest of world | — | 0 | — |
Investigational sites
Humanitas Mirasole S.p.A.
Radiosurgery, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliero Universitaria Di Modena
Oncology, Largo Del Pozzo 71, 41124, Modena
Azienda USL IRCCS Di Reggio Emilia
Oncology, Viale Risorgimento 80, 42123, Reggio Emilia
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Oncology, Corso Bramante 88, 10126, Turin
Ospedale Isola Tiberina Gemelli Isola
Oncology, Via Di Ponte Quattro Capi 39, 00186, Rome
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Oncology, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Radiotherapy, Via Consolare Valeria N 1, 98124, Messina
Casa Di Cura Macchiarella S.p.A.
Radiotherapy, Viale Regina Margherita 25, 90138, Palermo
ARNAS Civico Di Cristina Benfratelli
Oncology Radiotherapy, Piazza Nicola Leotta 4, 90127, Palermo
Azienda Ospedaliero Universitaria Careggi
Oncology, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliero Universitaria Parma
Oncology, Viale Antonio Gramsci 14, 43126, Parma
Centro Di Riferimento Oncologico Di Aviano
Oncology Radiotherapy, Via Franco Gallini 2, 33081, Aviano
IRCCS Ospedale Sacro Cuore Don Calabria
Oncology, Via Don Angelo Sempreboni 5, 37024, Negrar
Cliniche Gavazzeni S.p.A.
Radiotherapy, Via Mauro Gavazzeni 21, 24125, Bergamo
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-518388-37-00_For Publication | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Genetics | 2 |
| Subject information and informed consent form (for publication) | L1_ICF Privacy_For Publication | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy Partner | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_For Publication | 2 |
| Subject information and informed consent form (for publication) | L2_EORTC QLQ-PR25_QUESTIONNAIRE | 1 |
| Subject information and informed consent form (for publication) | L2_EORTC-QLQ-C30_QUESTIONNAIRE | 3 |
| Subject information and informed consent form (for publication) | L2_GP Letter | 1 |
| Subject information and informed consent form (for publication) | L2_IIEF5_QUESTIONNAIRE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Regulolix | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG_2024-518388-37-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ITA_2024-518388-37-00 | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-19 | Italy | Acceptable 2025-04-03
|
2025-04-03 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-04-04 | Italy | Acceptable 2025-04-03
|
2025-04-04 |