Overview
Sponsor-declared trial summary
Patients with biochemical recurrence after primary treatment of prostate cancer presenting with =<4 metastases
The overall aim of this project is to test the hypothesis that the addition of ADT to metastasis-directed radiotherapy (MDRT) in well-selected PCa patients with oligo-metastatic disease prolongs the metastases progression-free survival (MPFS) compared to MDRT alone
Key facts
- Sponsor
- Universitair Medisch Centrum Groningen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Jul 2024 → ongoing
- Decision date (initial)
- 2024-07-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511252-41-00
- EudraCT number
- 2019-003177-26
- ClinicalTrials.gov
- NCT04302454
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The overall aim of this project is to test the hypothesis that the addition of ADT to metastasis-directed radiotherapy (MDRT) in well-selected PCa patients with oligo-metastatic disease prolongs the metastases progression-free survival (MPFS) compared to MDRT alone
Secondary objectives 1
- The secondary aim is obtaining more insight into the sensitivity of the PSMA-PET scan for detecting (oligo)metastases by low PSA-levels.
Conditions and MedDRA coding
Patients with biochemical recurrence after primary treatment of prostate cancer presenting with =<4 metastases
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2019-003177-26 | Androgen Deprivation therapy for Oligo-recurrent Prostate cancer in addition to radioTherapy, Androgeendeprivatietherapie voor Oligo-recidiverende prostaatkanker in aanvulling op radiotherapie, Androgeendeprivatietherapie voor Oligo-recidiverende prostaatkanker in aanvulling op radiotherapie, Androgeendeprivatietherapie voor Oligo-recidiverende prostaatkanker in aanvulling op radiotherapie |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- Histologically proven initial diagnosis of adenocarcinoma of the Prostate.
- Biochemical recurrence of prostate cancer following primary local prostate treatment (radical prostatectomy, primary radiotherapy or radical prostatectomy +/- prostate bed adjuvant salvage radiotherapy) according to the EAU guidelines 2018. BCR after surgery: PSA > O.lng/ml. BCR after radiotherapy: PSA nadir +2 ng/ml (after exclusion of possible bounce effect).
- Maximum 4 lesions (bone + lymph nodes) in total, without evidence of viscerai metastases. a. Nodal relapse (NI) in the pelvis on PSMA-PET scan with a maximum of 4 positive lymph nodes. The upper limit of the pelvis is defined as the aortic bifurcation. b. Nodal relapse (Ml) on PSMA-PET scan above the aortic bifurcation with a maximum of 3 positive lymph nodes. c. Bone relapse on PSMA-PET scan with a maximum of 3 lesions.
- Age > 18 years.
- PSMA-PET/CT scan or PSMA-PET/MRI within 60 days prior to randomization.
- PSA < 10 ng/ml.
- In case of chronic use of finasteride the PSA value should be < 5 ng/ml.
- WHO performance state 0-2.
- DSigned informed consent prior to registration/randomization.
Exclusion criteria 8
- Visceral metastases.
- PSA => 10 ng/ml.
- PSA-doubling time < 3 months.
- ADT or chemotherapy for recurrent PCa.
- Testosterone < 1.7 nmol/l.
- Painful metastases needed pain medication.
- Previous or concurrent invasive active cancers other than superficial non-melanoma skin cancers.
- Inability to understand the information on trial-related topics, to give informed consent or to fill out QoL questionnaires.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint is the 2-year metastases progression free survival
Secondary endpoints 12
- 3 years PSA progression.
- Start of 2nd line treatment.
- Start 2nd MDRT treatment for new (progressive) oligometastases.
- Acute and late toxicity (late toxicity up to 3 years).
- Clinical progression-free survival.
- Quality of life.
- Progression pattern.
- Time to start of palliative ADT.
- Time to castration-resistance.
- Disease-specific and overall survival.
- Sensitivity of the imaging modality (PSMA-PET/CT or PSMA-PET/MRI) for patients receiving MDRT.
- Predictive biomarkers.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Eligard 22,5 mg poeder en oplosmiddel voor oplossing voor injectie
PRD8990123 · Product
- Active substance
- Leuprorelin Acetate
- Substance synonyms
- LEUPROLIDE ACETATE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 45 mg milligram(s)
- Max total dose
- 45 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02AE02 — LEUPRORELIN
- Marketing authorisation
- RVG 31669
- MA holder
- RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Groningen
- Sponsor organisation
- Universitair Medisch Centrum Groningen
- Address
- Hanzeplein 1
- City
- Groningen
- Postcode
- 9713 GZ
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- S. Aluwini
Public contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- S. Aluwini
Locations
1 EU/EEA country · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruitment ended | 280 | 10 |
| 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 |
|---|---|---|---|---|---|
| Netherlands | 2024-07-30 | 2024-07-30 | 2024-10-21 |
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) | D1_Protocol EU CT 2024-511252-41-00 | 5.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrengement Blanc documents | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Biomarkers deel 2 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF deel 1 | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC_Eligard EU CT 2024-511252-41-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-04 | Netherlands | Acceptable with conditions 2024-07-29
|
2024-07-29 |