Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
51
Countries
1
Sites
16
Oligometastatic patients with castration-resistant prostate cancer
Determine the PRFS measured from the time of initiation of secondgeneration antiandrogen to the time of radiological progression by choline PET/CT or 68Ga-PSMA PET/CT, in patients with mCRPC treated with the combination of second-generation antiandrogen plus SBRT.
Key facts
- Sponsor
- Instituto de investigación en Oncología radioterápica FEOR (Fundación Española de Oncología RT)
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Male Urogenital Diseases [C12]
- Trial duration
- 16 May 2024 → ongoing
- Decision date (initial)
- 2023-10-09
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Janssen
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy
Determine the PRFS measured from the time of initiation of secondgeneration antiandrogen to the time of radiological progression by choline PET/CT or 68Ga-PSMA PET/CT, in patients with mCRPC treated with the combination of second-generation antiandrogen plus SBRT.
Secondary objectives 3
- Overall survival (time from initiation of second-generation antiandrogen to exitus) in patients with mCRPC treated with the combination of second-generation antiandrogen plus SBRT.
- Quality of life of these patients using the European Organization for Research and Treatment of Cancer (EORTC) quality of life scale, EORTC QLQ-C30, validated for oncology patients.
- Acute and chronic toxicity according to the "Common Terminology Criteria for Adverse Events" (CTCAEv5.0) scale.
Conditions and MedDRA coding
Oligometastatic patients with castration-resistant prostate cancer
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-505024-62-00 | Fractionated stereotactic radiotherapy plus second-generation antiandrogen for oligometastatic patients with castration-resistant prostate cancer. Phase II Spanish study, prospective, multicenter. (OLIGORESIST) | Instituto de investigación en Oncología radioterápica FEOR (Fundación Española de Oncología RT) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Patients with histologically prostate adenocarcinoma, confirmed with a biopsy.
- Testosterone in biochemical castration ranges (testosterone <50 ng/ml or 1.7 nmol/L) and documented progression: biochemical according to Phoenix criteria or distant by radiological confirmation (PSMA PET/CT or Choline PET/CT).
- Radiological confirmation (with choline-PET/CT or PSMA-PET/CT) of ≤5 node or bone metastasis, non-visceral, eligible to receive SBRT treatment (< 3 cm major diameter in bone metastases, < 5 cm in lymph node metastases). In the case of very close metastases, a limit of up to 5 treatment fields with SBRT is allowed, instead of 5 metastases.
- Patients candidate to receive treatment with abiraterone or enzalutamide as per clinical routine, and treatment selection and prescription assigned by responsible physician before the inclusion in the study or or who has started treatment no more than 14 days prior to signing, as first-line treatment after a diagnosis of oligoresistance.
- Patients must provide written informed consent.
- Life expectancy > 3 months.
Exclusion criteria 6
- Patients with prostate carcinoma with histology other than adenocarcinoma.
- No previous biopsy.
- > 5 metastasis, not approachables in 5 treatment fields
- Patients with visceral metastasis and or metastasis non elegible to receive SBRT.
- Patients with Testosterone above castration levels.
- Patients with prior treatment with docetaxel as first-line CRPC treatment (previous docetaxel treatment is permitted when administered as hormone-sensitive metastatic prostate cancer treatment.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Radiological progression by choline PET/CT or 68Ga-PSMA PET/CT, in patients with mCRPC treated with the combination of second-generation antiandrogen plus SBRT.
Secondary endpoints 3
- Overall survival (time from initiation of second-generation antiandrogen to exitus) in patients with mCRPC treated with the combination of second-generation antiandrogen plus SBRT.
- Quality of life of these patients using the European Organization for Research and Treatment of Cancer (EORTC) quality QLQ-C30, validated for oncology patients. of life scale, EORTC .
- Acute and chronic toxicity according to the "Common Terminology Criteria for Adverse Events" (CTCAEv5.0) scale.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Abiraterona Normon 500 mg comprimidos revestidos por película
PRD10123666 · Product
- Active substance
- Abiraterone Acetate
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 1000 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BX03 — -
- Marketing authorisation
- 5849047
- MA holder
- LABORATÓRIOS NORMON, S.A.
- MA country
- Portugal
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Xtandi - 80 mg film-coated tablets
PRD5512949 · Product
- Active substance
- Enzalutamide
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 160 mg milligram(s)
- Max total dose
- 160 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BB04 — -
- Marketing authorisation
- EU/1/13/846/003
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Instituto de investigación en Oncología radioterápica FEOR (Fundación Española de Oncología RT)
- Sponsor organisation
- Instituto de investigación en Oncología radioterápica FEOR (Fundación Española de Oncología RT)
- Address
- Dr. Esquerdo, 105
- City
- Madrid
- Postcode
- 28007
- Country
- Spain
Scientific contact point
- Organisation
- Instituto de investigación en Oncología radioterápica FEOR (Fundación Española de Oncología RT)
- Contact name
- Pablo Raña Díez
Public contact point
- Organisation
- Instituto de investigación en Oncología radioterápica FEOR (Fundación Española de Oncología RT)
- Contact name
- Pablo Raña Díez
Locations
1 EU/EEA country · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 51 | 16 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital De La Santa Creu I Sant Pau
Radiation Oncology, Carrer De San Quinti 89, 08041, Barcelona
Complexo Hospitalario Universitario De Santiago
Radiation Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario De Cruces
Radiation Oncology, Cruces Plaza S/n, 48903, Barakaldo
Hospital Universitario Basurto
Radiation Oncology, Montevideo Etorbidea 16-18, 48013, Bilbao
Hospital Universitario De Salamanca
Radiation Oncology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Clinic De Barcelona
Radiation Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Unviersitario Miguel Servet
Radiation Oncology, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Universitario Rey Juan Carlos
Radiation Oncology, Calle Gladiolo S/n, 28933, Mostoles
Hospital Universitario Central De Asturias
Radiation Oncology, Avenida De Roma S/n, 33011, Oviedo
Consorci Sanitari De Terrassa
Radiation Oncology, Carretera Torrebonica Sn, 08227, Terrassa
Hospital Universitario De Navarra
Radiation Oncology, Irunlarrea Kalea 3, 31008, Pamplona
Hospital Clinico San Carlos
Radiation Oncology, Calle De Martin Fierro Sn, 28040, Madrid
Hospital Clinico Universitario De Valladolid
Radiation Oncology, Avenida Ramon Y Cajal 3, 47003, Valladolid
Institut Catala D'oncologia
Radiation Oncology, Avinguda Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Y Politecnico La Fe
Radiation Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Ramón y Cajal
Radiation Oncology, M-607, Km. 9, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2024-05-16 | 2024-05-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocolo OLIGORESIST v1 6_18-08-2023 | 1.6 |
| Protocol (for publication) | Protocolo OLIGORESIST v1 6_18-08-2023_highlighted changes | v2.0 |
| Protocol (for publication) | Protocolo OLIGORESIST v3 23mar2026 | 3 |
| Protocol (for publication) | Protocolo OLIGORESIST v3 23mar2026 cambios resaltados | 3 |
| Protocol (for publication) | Protocolo OLIGORESIST vFINAL20marzo2023 | v2.0 |
| Recruitment arrangements (for publication) | informedconsent_patientrecruitmentprocedure_en | 1 |
| Subject information and informed consent form (for publication) | HIP CI OLIGORESIST v1_1 16sept2022 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | xtandi-epar-product-information_es | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | zytiga-epar-product-information_es | 1 |
| Synopsis of the protocol (for publication) | protocol synopsis OLIGORESIST | v2.0 |
| Synopsis of the protocol (for publication) | protocol synopsis OLIGORESIST v3 con cambios resaltados ingles | 3 |
| Synopsis of the protocol (for publication) | protocol synopsis OLIGORESIST v3 ingles | 3 |
| Synopsis of the protocol (for publication) | resumen protocolo OLIGORESIST 18ago2023 | 1 |
| Synopsis of the protocol (for publication) | resumen protocolo v3 OLIGORESIST con cambios resaltados | 1 |
| Synopsis of the protocol (for publication) | resumen protocolo v3 OLIGORESIST def espanol | 3 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-05 | Spain | Acceptable 2023-10-09
|
2023-10-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-27 | |||
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-05 | Spain | Acceptable | 2024-10-03 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-10 | Spain | Acceptable 2025-12-15
|
2025-12-18 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-16 | Spain | Acceptable 2025-12-15
|
2026-04-16 |