Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
450
Countries
1
Sites
5
Biochemical recurrence after prostate cancer surgery
To compare the efficacy of individualized PSMA PET/CT targeted treatment compared with conventional "salvage" radiotherapy in patients with biochemical recurrence after prostate cancer surgery. Main objective PSA progression free survival
Key facts
- Sponsor
- Karolinska University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Oct 2018 → ongoing
- Decision date (initial)
- 2023-05-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Erhling-Perssons foundation.
External identifiers
- EU CT number
- 2023-504917-54-00
- EudraCT number
- 2018-002273-22
- ClinicalTrials.gov
- NCT04794777
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To compare the efficacy of individualized PSMA PET/CT targeted treatment compared with conventional "salvage" radiotherapy in patients with biochemical recurrence after prostate cancer surgery. Main objective PSA progression free survival
Secondary objectives 5
- In the context of PSMA PET/CT individualized treatment vs. conventional "salvage" radiotherapy, compare quality of life outcomes
- In the context of PSMA PET/CT individualized treatment vs. conventional "salvage" radiotherapy, compare time to secondary treatment
- In the context of PSMA PET/CT individualized treatment vs. conventional "salvage" radiotherapy, compare time to metastatis
- In the context of PSMA PET/CT individualized treatment vs. conventional "salvage" radiotherapy, compare overall and cancer specific survival
- In the context of PSMA PET/CT individualized treatment vs. conventional "salvage" radiotherapy, compare health economics
Conditions and MedDRA coding
Biochemical recurrence after prostate cancer surgery
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10036911 | Prostate cancer recurrent | 100000004864 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Randomisation With randomization 1:2; 1/3=33.3% of all patients till be randomized to control arm and 2/3=66.7% of all patients will be randomized to experimental arm. Control arm will receive conventional SRT. Experimental arm will receive individual treatment based on results of PSMA PET/CT.
|
Randomised Controlled | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Patients previously treated for prostate cancer with radical prostatectomy and now having a biochemical recurrence (BCR) defined as: PSA >0.2 <2.0 ng/mL, and increasing measured twice.
- Multidisciplinary conference (MDK) decision to offer the patient salvage radiotherapy (SRT).
- Signed Informed Consent
Exclusion criteria 4
- Previous prostate cancer with biochemical recurrence
- Previous treatment with ADT after surgery
- Previous pelvic radiotherapy
- Patients with positive lymph nodes at surgery
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Primary PSA progression free survival (PFS) defined as documented biological progression: No response to SRT: the PSA value 3 months after completion of SRT is ≥ 0.1 ng/mL higher than the PSA value just before radiotherapy. Progression after initial response to SRT: Two rising PSA values ≥ 0.1 ng/mL after completion of radiotherapy, with the last value ≥ 0.2 ng/mL.
Secondary endpoints 5
- Time to metastasis
- Prostate cancer specific survival
- Overall survival
- Time to secondary treatment: Time from randomization to start of secondary treatment, usually hormonal treatment
- Quality of life: All patients fill in PSMA-PROM, a study modified quality of life questionnaire developed by the National PCa Register at baseline and 6, 12, 36, and 60 months after completed treatment.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Locametz 25 micrograms kit for radiopharmaceutical preparation
PRD10117083 · Product
- Active substance
- Gozetotide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 150 MBq megabecquerel(s)
- Max total dose
- 300 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX14 — -
- Marketing authorisation
- EU/1/22/1692/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10378775 · Product
- Active substance
- (3S10S14S-1-4-2S-4-CARBOXY-2-2S-4-CARBOXY-2-6-18F] FLUOROPYRIDIN-3-AMIDOBUTANAMIDOBUTANAMIDOMETHYLPHENYL-3-NAPHTHALEN-2-YLMETHYL-1412-TRIOXO-251113-TETRAAZAHEXADECANE-101416-TRICARBOXYLIC Acid
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 250 Bq becquerel(s)
- Max total dose
- 250 Bq becquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- KAROLINSKA
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Karolinska University Hospital
- Sponsor organisation
- Karolinska University Hospital
- Address
- Eugeniavagen 3
- City
- Solna
- Postcode
- 171 64
- Country
- Sweden
Scientific contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Stefan Carlsson
Public contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Stefan Carlsson
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 450 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Soedersjukhuset AB
Department of Oncology, Sjukhusbacken 10, Hogalid, Stockholm
Karolinska University Hospital
Department of Molecular Medicine and Surgery, Eugeniavagen 3, 171 64, Solna
Norrlands University Hospital
Cancercentrum, Daniel Naezens Vag, 907 37, Umea
Region Oerebro Laen
Dept. of Urology, Sodra Grev Rosengatan, 701 85, Orebro
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Dept. of Urology at Institute of Clinical Sciences, Bruna Straket 16, 413 46, Gothenburg
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 |
|---|---|---|---|---|---|
| Sweden | 2018-10-30 | 2018-11-16 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-504917-54-00 PSMA Study clean | 6 |
| Protocol (for publication) | D1_Protocol 2023-504917-54-00 PSMA Study tc | 6 |
| Protocol (for publication) | Protocol 2023-504917-54-00 | 5.0 |
| Recruitment arrangements (for publication) | Blank document 2023-504917-54-00 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF clean | 4.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF tc | 4.2 |
| Subject information and informed consent form (for publication) | SIS and ICF 2023-504917-54-00 | 4.1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC locametz | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol svenskt synopsis 2023-504917-54-00 PSMA | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-12 | Sweden | Acceptable 2023-05-22
|
2023-05-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-08-21 | Sweden | Acceptable 2024-10-07
|
2024-10-09 |