Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
35
Countries
1
Sites
1
Metastatic prostate cancer, Prostate cancer
To demonstrate that PSMA-flare seen 2-3weeks after initiation of ADT at baseline is more common in bony lesions than in prostatic lesions
Key facts
- Sponsor
- Turku University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Male Urogenital Diseases [C12], Diseases [C] - Neoplasms [C04], Diseases [C] - Hormonal diseases [C19]
- Trial duration
- 15 Apr 2019 → ongoing
- Decision date (initial)
- 2025-01-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519516-14-01
- EudraCT number
- 2018-004853-26
- ClinicalTrials.gov
- NCT03876912
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis, Efficacy
To demonstrate that PSMA-flare seen 2-3weeks after initiation of ADT at baseline is
more common in bony lesions than in prostatic lesions
Secondary objectives 5
- To study if metastatic lesions with and without PSMA-flare seen in baseline behave differently in repeated 18F-PSMA-PET CT at the time of CRPC
- To compare the metastatic load seen in 18F-PSMA-PET CT and FDG-PET-CT at baseline (Sub-study 1)
- To determine the total androgen profile during the evolution of metastatic Pca by repeated total androgen measurements in every six months from diagnosis to the development of CRPC (Sub-study 2)
- To biopsy prostate lesions seen on 18F-PSMA PET and determine if the changes of PSMA uptake after ADT might have a histopathological correlation (Substudy 3)
- To investigate gut microbiome and its changes during ADT (Substudy 4)
Conditions and MedDRA coding
Metastatic prostate cancer, Prostate cancer
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-519516-14-00 | The effect of androgen deprivation therapy on the expression of prostate specific membrane antigen (PSMA) in treatment naive metastatic prostate cancer | Turku University Hospital |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- Age: 40 to 85 years old
- Language spoken: Finnish and Swedish
- Diagnosis: Histologically confirmed adenocarcinoma of prostate
- Adequate histological sampling consisting of at least 3 biopsy samples from each lobe
- No previous surgical, radiation or endocrine treatment for prostate carcinoma
- Clinical stage: T1c-T4NanyM1
- Serum creatinine ≤ 1,5 x ULN
- Mental status: Patients must be able to understand the meaning of the study
- Informed consent: The patient must sign the appropriate Ethical Committee approved informed consent documents in the presence of the designated staff
Exclusion criteria 2
- Previous PC treatment
- Uncontrolled serious infection
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To demonstrate that PSMA-flare seen 2-3weeks after initiation of ADT at baseline is more common in bony lesions than in prostatic lesions
Secondary endpoints 5
- To study if metastatic lesions with and without PSMA-flare seen in baseline behave differently in repeated 18F-PSMA-PET CT at the time of CRPC
- To compare the metastatic load seen in 18F-PSMA-PET CT and FDGPET- CT at baseline (Sub-study 1)
- To determine the total androgen profile during the evolution of metastatic Pca by repeated total androgen measurements in every six months from diagnosis to the development of CRPC (Sub-study 2)
- To biopsy prostate lesions seen on 18F-PSMA PET and determine if the changes of PSMA uptake after ADT might have a histopathological correlation (Substudy 3)
- To investigate gut microbiome and its changes during ADT (Substudy 4)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP8252543 · ATC
- Active substance
- Degarelix
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 240 mg milligram(s)
- Max total dose
- 240 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L02BX02 — DEGARELIX
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Turku University Hospital
- Sponsor organisation
- Turku University Hospital
- Address
- Kiinamyllynkatu 4-8
- City
- Turku
- Postcode
- 20520
- Country
- Finland
Scientific contact point
- Organisation
- Turku University Hospital
- Contact name
- Turku University Hospital
Public contact point
- Organisation
- Turku University Hospital
- Contact name
- Turku University Hospital
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruiting | 35 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Finland | 2019-04-15 | 2019-04-15 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 5_ADTPSMA2_reserch plan_1_4_for_CTIS_transition | 1 |
| Recruitment arrangements (for publication) | ADTPSMA2 Selvitys rekrytoinnista | 1 |
| Subject information and informed consent form (for publication) | ADTPSMA2 potilasinfo | 1 |
| Subject information and informed consent form (for publication) | ADTPSMA2 suostumus | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | ADTPSMA_Firmagon valmisteyhteenveto | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-27 | Finland | Acceptable 2025-01-28
|
2025-01-28 |