Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Authorised, recruiting
Participants planned
493
Countries
2
Sites
16
Prostate cancer
Phase 3 Intensification study: To determine improvements in PSMA PET/ CT metastasis-free survival (ppMFS), where ppMFS is defined as the time from randomization to the date of at least 1 new PSMA-PET-positive distant lesion as compared to baseline or date of death from any cause Phase 2 De-intensification study: To det…
Key facts
- Sponsor
- Ziekenhuis Aan De Stroom
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 13 Dec 2023 → ongoing
- Decision date (initial)
- 2023-09-20
- 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
Phase 3 Intensification study: To determine improvements in PSMA PET/ CT metastasis-free survival (ppMFS), where ppMFS is defined as the time from randomization to the date of at least 1 new PSMA-PET-positive distant lesion as compared to baseline or date of death from any cause
Phase 2 De-intensification study: To determine improvements in Quality of Life indices and effectiveness of up to 96 weeks (24 months) of darolutamide plus SOC RT as an alternative to standard treatment (24 months ADT [LHRHA] plus SOC RT) or standard treatment with ADT plus darolutamide.
Secondary objectives 6
- Overall survival (OS)
- Prostate cancer-specific survival
- Biochemical progression-free survival
- Time to next therapy
- Frequency and severity of adverse events (AEs)
- To determine differential treatment effects by comparing HRQL scores between the randomly allocated groups (where applicable)
Conditions and MedDRA coding
Prostate cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Histopathology-proven PCa
- High-risk disease as any of the following factors: PSA > 20 ng/mL or T-stage 3 or 4 or Gleason score 8-10
- An Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1
- Willingness to undergo a PSMA PET/ CT with or without contrast.
- Willingness to have their primary tumor sequenced for determination of Decipher score
- Willingness to undergo SOC RT and long-term ADT (treatment with darolutamide and/ or LHRHA)
Exclusion criteria 5
- Definitive radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e., bone scan, CT scan, MRI)
- PCa with predominant non-adenocarcinoma features (sarcomatoid or spindle or neuroendocrine small cell or squamous cell components or other non-adenocarcinoma)
- Prior pelvic radiotherapy
- Prior local therapy for PCa
- Prior systemic therapy for PCa
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Phase 3 Intensification study: Incidence of ppMFS over time. PSMA PET metastatic progression is defined as the appearance of at least 1 new PSMA-PET-positive distant lesion compared with the baseline scan or date of death from any cause.
- Phase 2 De-intensification study: Health related Quality of Life (HRQL) will be reported by subjects using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. A clinically important point reduction in EPIC subdomain score is defined as follows: sexual (11 points), and hormonal (5 points) as detected at 12 months. EPIC scores will be measured on a yearly basis to monitor late effects.
Secondary endpoints 6
- OS will be measured from the date of randomization to the date of death or last known follow-up date, with patients alive at the last known follow-up time treated as censored
- Prostate cancer-specific mortality (PCSM) will be measured from the date of randomization to the date of prostate cancer death.
- Biochemical progression-free survival will be measured from the date of randomization to the date event, or death or censored at the last known follow-up date. Events are PSA failure, castrate resistance (EAU Guidelines on Prostate Cancer 2022), receiving salvage therapy, or death from any cause.
- Time to next systemic therapy (NEST) will be measured from date of randomization to time of death, or censored at the last known follow-up date. Events for NEST are receiving any local therapy (surgery, radiotherapy, HIFU, cryotherapy) or systemic therapy for prostate cancer.
- Counts of all AEs by grade will be provided by study (Phase 2 and 3) and treatment arm
- EPIC mean changes in subdomain scores over time will be compared, both for change from baseline and absolute health related quality of life scores.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD1849573 · Product
- Active substance
- Darolutamide
- Other product name
- ODM-201 300 mg film-coated tablet
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BAYER AG
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Auxiliary 21
Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion
PRD3445547 · Product
- Active substance
- Docetaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 75 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD02 — DOCETAXEL
- Marketing authorisation
- EU/1/12/769/003
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
DEPO-ELIGARD 7,5 mg, poeder en oplosmiddel voor oplossing voor injectie
PRD8982504 · Product
- Active substance
- Leuprorelin Acetate
- Substance synonyms
- LEUPROLIDE ACETATE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 7.5 mg milligram(s)
- Max total dose
- 7.5 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- L02AE02 — LEUPRORELIN
- Marketing authorisation
- BE274032
- MA holder
- RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Orgovyx 120 mg film-coated tablets
PRD10359492 · Product
- Active substance
- Relugolix
- Substance synonyms
- TAK-385
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 120 mg milligram(s)
- Max total dose
- 120 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- L02BX04 — -
- Marketing authorisation
- EU/1/22/1642/002
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion
PRD3445553 · Product
- Active substance
- Docetaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 75 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD02 — DOCETAXEL
- Marketing authorisation
- EU/1/12/769/002
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
DEPO-ELIGARD 22,5 mg, poeder en oplosmiddel voor oplossing voor injectie
PRD8982508 · Product
- Active substance
- Leuprorelin Acetate
- Substance synonyms
- LEUPROLIDE ACETATE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 22.5 mg milligram(s)
- Max total dose
- 22.5 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- L02AE02 — LEUPRORELIN
- Marketing authorisation
- BE274023
- MA holder
- RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
FIRMAGON 80 mg powder and solvent for solution for injection
PRD425269 · Product
- Active substance
- Degarelix
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 80 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- L02BX02 — -
- Marketing authorisation
- EU/1/08/504/001
- MA holder
- FERRING PHARMACEUTICALS A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Docetaxel AB 20 mg/ml concentraat voor oplossing voor infusie
PRD4114693 · Product
- Active substance
- Docetaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 75 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD02 — DOCETAXEL
- Marketing authorisation
- BE378725
- MA holder
- AUROBINDO N.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD395468 · Product
- Active substance
- Goserelin Acetate
- Pharmaceutical form
- IMPLANT
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 3.6 mg milligram(s)
- Max total dose
- 3.6 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- L02AE03 — GOSERELIN
- Marketing authorisation
- BE138731
- MA holder
- ASTRAZENECA S.A. / N.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ZOLADEX Long Acting, 10,8 mg, implant
PRD395546 · Product
- Active substance
- Goserelin Acetate
- Pharmaceutical form
- IMPLANT
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 10.8 mg milligram(s)
- Max total dose
- 10.8 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- L02AE03 — GOSERELIN
- Marketing authorisation
- BE179277
- MA holder
- ASTRAZENECA S.A. / N.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
TAXOTERE 160 mg/8 ml concentrate for solution for infusion.
PRD479263 · Product
- Active substance
- Docetaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 75 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD02 — DOCETAXEL
- Marketing authorisation
- EU/1/95/002/005
- MA holder
- SANOFI MATURE IP
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD2027857 · Product
- Active substance
- Triptorelin
- Substance synonyms
- TRIPTORELINE
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 11.25 mg milligram(s)
- Max total dose
- 11.25 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- L02AE04 — TRIPTORELIN
- Marketing authorisation
- BE192516
- MA holder
- IPSEN N.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Docetaxel AB 20 mg/ml concentraat voor oplossing voor infusie
PRD4114692 · Product
- Active substance
- Docetaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 75 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD02 — DOCETAXEL
- Marketing authorisation
- BE378734
- MA holder
- AUROBINDO N.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion
PRD3445550 · Product
- Active substance
- Docetaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 75 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD02 — DOCETAXEL
- Marketing authorisation
- EU/1/12/769/001
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
DEPO-ELIGARD 45 mg, poeder en oplosmiddel voor oplossing voor injectie
PRD8982507 · Product
- Active substance
- Leuprorelin Acetate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 45 mg milligram(s)
- Max total dose
- 45 mg/g milligram(s)/gram
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- L02AE02 — LEUPRORELIN
- Marketing authorisation
- BE314973
- MA holder
- RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
TAXOTERE 80 mg/4 ml concentrate for solution for infusion
PRD479238 · Product
- Active substance
- Docetaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 75 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD02 — DOCETAXEL
- Marketing authorisation
- EU/1/95/002/004
- MA holder
- SANOFI MATURE IP
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Docetaxel AB 20 mg/ml concentraat voor oplossing voor infusie
PRD4114691 · Product
- Active substance
- Docetaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 75 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD02 — DOCETAXEL
- Marketing authorisation
- BE496720
- MA holder
- AUROBINDO N.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Orgovyx 120 mg film-coated tablets
PRD9814932 · Product
- Active substance
- Relugolix
- Substance synonyms
- TAK-385
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 120 mg milligram(s)
- Max total dose
- 120 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- L02BX04 — -
- Marketing authorisation
- EU/1/22/1642/001
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD390686 · Product
- Active substance
- Triptorelin
- Pharmaceutical form
- PROLONGED-RELEASE SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 22.5 mg milligram(s)
- Max total dose
- 22.5 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- L02AE04 — TRIPTORELIN
- Marketing authorisation
- BE362284
- MA holder
- IPSEN N.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD2027871 · Product
- Active substance
- Triptorelin
- Substance synonyms
- TRIPTORELINE
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR
- Max daily dose
- 3.75 mg milligram(s)
- Max total dose
- 3.75 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- L02AE04 — TRIPTORELIN
- Marketing authorisation
- BE145826
- MA holder
- IPSEN N.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Docetaxel AB 20 mg/ml concentraat voor oplossing voor infusie
PRD4128959 · Product
- Active substance
- Docetaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 75 mg/m2 milligram(s)/square meter
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD02 — DOCETAXEL
- Marketing authorisation
- BE378716
- MA holder
- AUROBINDO N.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
FIRMAGON 120 mg powder and solvent for solution for injection
PRD425270 · Product
- Active substance
- Degarelix
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 120 mg milligram(s)
- Max total dose
- 120 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- L02BX02 — -
- Marketing authorisation
- EU/1/08/504/002
- MA holder
- FERRING PHARMACEUTICALS A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ziekenhuis Aan De Stroom
- Sponsor organisation
- Ziekenhuis Aan De Stroom
- Address
- Kempenstraat 100
- City
- Antwerp
- Postcode
- 2030
- Country
- Belgium
Scientific contact point
- Organisation
- Ziekenhuis Aan De Stroom
- Contact name
- Clinical Trials Office
Public contact point
- Organisation
- Ziekenhuis Aan De Stroom
- Contact name
- Clinical Trials Office
Locations
2 EU/EEA countries · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 403 | 11 |
| Spain | Authorised, recruiting | 90 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Institut Jules Bordet
Radiotherapy, Mijlenmeersstraat 90, 1070, Anderlecht
CHU De Liege
Medical Oncology, Avenue De L'hopital 1, 4000, Liege
Algemeen Ziekenhuis Groeninge
Radiotherapy, President Kennedylaan 4, 8500, Kortrijk
Ziekenhuis Aan De Stroom
Radiotherapy, Oosterveldlaan 24, 2610, Antwerp
Vitaz
Urology, Moerlandstraat 1, 9100, Sint-Niklaas
Az St-Jan Brugge-Oostende A.V.
Radiotherapy, Ruddershove 10, 8000, Brugge
Az Delta
Radiotherapy, Deltalaan 1, 8800, Roeselare
Universitair Ziekenhuis Gent
Radiotherapy, Corneel Heymanslaan 10, 9000, Gent
Cliniques Universitaires Saint-Luc
Radiotherapy, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
CHU Helora
Oncology, Rue Ferrer 159 Boite 1, 7100, La Louviere
Azorg
Radiotherapy, Moorselbaan 164, 9300, Aalst
Hospital Universitario Y Politecnico La Fe
Radiation Oncology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Virgen De La Victoria
Radiation Oncology, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Hospital Universitario 12 De Octubre
Clinical Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Ramon Y Cajal
Clinical Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital De La Santa Creu I Sant Pau
Radiation Oncology, Carrer De San Quinti 89, 08041, Barcelona
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 |
|---|---|---|---|---|---|
| Belgium | 2023-12-13 | 2023-12-13 | |||
| Spain | 2026-03-25 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 22 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2022 501551 90 00 | 6 |
| Protocol (for publication) | D1_Protocol 2022 501551 90 00 TC | 6 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_redacted | 1 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | EPIC 50 questionnaire | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults EN | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults FR | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults FR TC | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults NL | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults NL TC | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material EPIC questionnaire EN | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material EPIC questionnaire FR | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material EPIC questionnaire NL | 1 |
| Subject information and informed consent form (for publication) | PIS_general | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Darolutamide | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis DE 2022 501151 90 00 TC | 6 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis DE 2022 501551 90 00 | 6 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis FR 2022 501551 90 00 | 6 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis FR 2022 501551 90 00 TC | 6 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NL 2022 501551 90 00 | 6 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NL 2022 501551 90 00 TC | 6 |
| Synopsis of the protocol (for publication) | Protocol summary_2025_03_14 | 6 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-04 | Belgium | Acceptable 2023-09-20
|
2023-09-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-09 | Belgium | Acceptable 2023-11-09
|
2023-11-20 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-01 | Belgium | Acceptable 2024-08-14
|
2024-08-30 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-12-30 | Belgium | Acceptable 2025-02-14
|
2025-02-14 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-03-14 | Belgium | Acceptable 2025-05-14
|
2025-05-14 |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2025-10-28 | 2026-01-23 | ||
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-03-06 | Belgium | Acceptable 2026-05-11
|
2026-05-11 |