Prostate Cancer MetastaticPhase 2CRPCNCT02825628
Study of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC)
A Phase 2 study testing Osteodex in people with Prostate Cancer Metastatic, run by DexTech Medical AB at 8 sites in 4 countries.
Trial summary
This is a phase II randomised, double-blind, dose finding, repeat dose Phase II multicentre study of ODX for the treatment of patients with castration resistant prostate cancer (CRPC) and skeletal metastases. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic
- What is being tested?
- Osteodex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 8 sitesin 4 countries
- Study dates
- May 2016to Jun 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years at the time of signing the informed consent form
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
- Evidence of disease progression based on changes in metastatic bone disease (≥2 bone lesions compared to a prior examination) in bone scan and/or other imaging modality AND/OR evidence of PSA progression in the three consecutive determinations at minimum of 1 week intervals
- Castrate level of serum testosterone ≤1.7 nmol/L
- Performance status ECOG 0-2
- Laboratory requirements:
Show all 14Show fewer
- Haematology:
- Neutrophils ≥ 1.5 x 109/l Haemoglobin ≥ 90 g/l Platelets ≥ 100 x 109/l
- Hepatic function:
- Total S-bilirubin ≤ 1.5 times the upper limit of normal (ULN) AST (SGOT) / ALT (SGPT) ≤ 2.5 times ULN or ≤ 5 times ULN in patients with known liver metastases
- Renal function:
- S-creatinine (S-Cr)≤ 1.5 times ULN
- No evidence (≤ 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin)
- Able to adhere to the study visit schedule and other protocol requirements Life expectancy ≥6 months
Who cannot join
- Concurrent use of other anti-cancer agents or treatments, with the following exception: a stable dose of Luteinizing Hormone-Releasing Hormone (LHRH) agonist/antagonist or polyestradiol phosphate. Washout period: bicalutamide 6 weeks; flutamide 4 weeks; abiraterone / enzalutamide 6 weeks, chemotherapy 4 weeks; Radium-223 4 weeks; Strontium-89 or Samarium-153 6 months.
- Any treatment modalities involving palliative radiation therapy or major surgery within 4 weeks prior to treatment in this study
- Simultaneous participation in any other study involving investigational drugs or having participated in a study less than 4 weeks prior to start of study treatment
- Any condition, including the presence of laboratory abnormalities, which confounds the ability to interpret data from the study or places the patient at unacceptable risk if he participates in the study
- Known brain metastases
- Dental surgery (dental extraction), periodontal disease, local trauma including poorly fitting dentures within 6 months prior to the first dose of study drug
- Treatment with bisphosphonates or denosumab within 4 weeks prior to first dose of study medication
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Sweden3 sites
Örebro University Hospital
Örebro, 70185
Urology Clinic, Sodersjukhuset AB
Stockholm, 118 83
Oncology Clinic, Norrlands Universitetssjukhus
Umeå, 901 85
Estonia2 sites
East Tallinn Central Hospital
Tallinn, 10138
Tartu University Hospital
Tartu, 51014
Latvia2 sites
Latgales Urology Center
Daugavpils, 5401
Pauls Strandins Clinical University Hospital
Riga, 1002
About this study
Official title: A Randomised, Double-blind, Dose Finding, Repeat Dose Phase II Multicentre Study of ODX for the Treatment of Patients With Castration Resistant Prostate Cancer (CRPC) and Skeletal Metastases
This is a phase II randomised, double-blind, dose finding, repeat dose Phase II multicentre study of ODX for the treatment of patients with castration resistant prostate cancer (CRPC) and skeletal metastases.
The primary objective is to evaluate the relative change from baseline in response markers related to bone metabolism (alkaline phosphatase (B-ALP) and S P1NP) at 12 weeks of three different doses of ODX (3.0, 6.0 and 9.0 mg/kg ODX).
Read the detailed description
Males, diagnosed with CRPC, who fulfil the inclusion criteria and does not have any exclusion criteria, will be asked to participate in the study. The subject will be informed orally and in writing about the study procedures and give written informed consent, prior to study start.
At the screening visit the following examinations are performed: Physical examination, medical history and concomitant medication. Heart rate, blood pressure, weight, height, body temperature and respiratory rate are measured. Blood samples are drawn and urine sample is collected. ECG is recorded. Bone scan and diagnostic CT scan are also performed. At the next visit, baseline, the subject is examined physically and heart rate, blood pressure, weight, body temperature and respiratory rate are measured, ECG is recorded, blood samples drawn and urine sample collected. FACT-P and EQ-5D-5L (European Quality of Life - 5 Dimensions with 5 levels) questionnaire are filled out by the subject. Adverse events and concomitant medication is documented and the first dose of the investigational product is given.
The subject is surveyed for 3 hours at the hospital.
The duration of the study for the individual subject will be approximately 20 weeks from screening to the follow-up visit 2 weeks after the last dose. Each subject will receive 10 doses of investigational product. After the follow-up visit, the subject enters to long-term follow-up phase which lasts approximately 2 years.
A Data Monitoring Committee (DMC) will be designated and will be responsible to monitor/review all study related safety data. After review of safety data the DMC will provide recommendation as to whether the dose escalation can proceed as planned according to the protocol.
- Conditions
- Prostate Cancer Metastatic
- Being tested
- Osteodex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteodexDrug
Also called ODX
formulation: solution for infusion route of administration: intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Osteodex 3.0 mg/kg | Experimental | formulation: solution for infusion route of administration: intravenous infusion Receives: Drug: Osteodex |
| Osteodex 6.0 mg/kg | Experimental | formulation: solution for infusion route of administration: intravenous infusion Receives: Drug: Osteodex |
| Osteodex 9.0 mg/kg | Experimental | formulation: solution for infusion route of administration: intravenous infusion Receives: Drug: Osteodex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change from baseline in response markers related to bone metabolism (B-ALP and S P1NP).
Measured: Baseline and 20 weeks of treatment
Secondary outcomes (19)
Progression free survival, defined as the time from study entry to the date of disease progression or death from any cause.
Measured: Baseline, 20 weeks of treatment and long-term follow-up up to 24 weeks
Overall survival, defined as the time from randomisation to the date of death from any cause.
Measured: Baseline, 20 weeks of treatment and long-term follow-up up to 24 weeks
Change from baseline in response markers related to bone metabolism (B-ALP and S P1NP) at each time point sampled (except 12 weeks).
Measured: Baseline and 20 weeks of treatment
Change from baseline in response markers related to bone metabolism (Serum C-Terminal Telopeptide (S-CTX) and osteocalcin) at each time point sampled.
Measured: Baseline and 20 weeks of treatment
Change from baseline in Prostate Specific Antigen (PSA) at each time point sampled.
Measured: Baseline and 20 weeks of treatment
Time to PSA progression
Measured: Baseline and 20 weeks of treatment
Time to ALP progression
Measured: Baseline and 20 weeks of treatment
Time to P1NP progression
Measured: Baseline and 20 weeks of treatment
Time to progression in bone
Measured: Baseline and 20 weeks of treatment
Time to progression in soft tissue
Measured: Baseline and 20 weeks of treatment
Use of analgesics as reported by the patient during treatment and follow-up
Measured: Baseline, 20 weeks of treatment and long-term follow-up up to 24 weeks
Therapy response based on changes from baseline according to Response Evaluation Criteria In Solid Tumors (RECIST) based on diagnostic CT in patients with measurable soft tissue metastases.
Measured: Baseline and 20 weeks of treatment
Changes from baseline in bone metastasis by means of bone scan at each time point examined.
Measured: Baseline and 20 weeks of treatment
Occurrence of symptomatic skeletal events
Measured: Baseline, 20 weeks of treatment and long-term follow-up up to 24 weeks
Pain (FACT-P questionnaire)
Measured: Baseline and 20 weeks of treatment
Pain (EQ-5D-5L questionnaire)
Measured: Baseline and 20 weeks of treatment
Quality of life (EQ-5D-5L questionnaire)
Measured: Baseline and 20 weeks of treatment
Incidence, causality and intensity of Adverse Events (AEs)
Measured: Baseline, 20 weeks of treatment and long-term follow-up up to 24 weeks
Dose and duration of medications required for the treatment of AEs
Measured: Baseline, 20 weeks of treatment and long-term follow-up up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2018
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- DexTech Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anders Holmberg, MD, Study director, DexTech Medical AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825628
- Sponsor's protocol ID
- ODX-003
- Acronym
- CRPC
- Status last verified
- Aug 2024
- First submitted
- 27 Jun 2016
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Thellenberg-Karlsson C, Vjaters E, Kase M, Tammela T, Ojamaa K, Norming U, Nyman C, Andersson SO, Hublarovs O, Marquez-Holmberg M, Castellanos E, Ullen A, Holmberg A, Nilsson S. A randomised, double-blind, dose-finding, phase II multicentre study of ODX in the treatment of patients with castration-resistant prostate cancer and skeletal metastases. Eur J Cancer. 2023 Mar;181:198-207. doi: 10.1016/j.ejca.2022.12.006. Epub 2022 Dec 20.
PubMed 36682096
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Dose Finding, Repeat Dose Phase II Multicentre Study of ODX for the Treatment of Patients With Castration Resistant Prostate Cancer (CRPC) and Skeletal Metastases
- ClinicalTrials.gov ID
- NCT02825628
- Acronym / sponsor ID
- CRPC / ODX-003
- Conditions
- Prostate Cancer Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- DexTech Medical ABIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II randomised, double-blind, dose finding, repeat dose Phase II multicentre study of ODX for the treatment of patients with castration resistant prostate cancer (CRPC) and skeletal metastases.
The primary objective is to evaluate the relative change from baseline in response markers related to bone metabolism (alkaline phosphatase (B-ALP) and S P1NP) at 12 weeks of three different doses of ODX (3.0, 6.0 and 9.0 mg/kg ODX).
Detailed description
Males, diagnosed with CRPC, who fulfil the inclusion criteria and does not have any exclusion criteria, will be asked to participate in the study. The subject will be informed orally and in writing about the study procedures and give written informed consent, prior to study start.
At the screening visit the following examinations are performed: Physical examination, medical history and concomitant medication. Heart rate, blood pressure, weight, height, body temperature and respiratory rate are measured. Blood samples are drawn and urine sample is collected. ECG is recorded. Bone scan and diagnostic CT scan are also performed. At the next visit, baseline, the subject is examined physically and heart rate, blood pressure, weight, body temperature and respiratory rate are measured, ECG is recorded, blood samples drawn and urine sample collected. FACT-P and EQ-5D-5L (European Quality of Life - 5 Dimensions with 5 levels) questionnaire are filled out by the subject. Adverse events and concomitant medication is documented and the first dose of the investigational product is given.
The subject is surveyed for 3 hours at the hospital.
The duration of the study for the individual subject will be approximately 20 weeks from screening to the follow-up visit 2 weeks after the last dose. Each subject will receive 10 doses of investigational product. After the follow-up visit, the subject enters to long-term follow-up phase which lasts approximately 2 years.
A Data Monitoring Committee (DMC) will be designated and will be responsible to monitor/review all study related safety data. After review of safety data the DMC will provide recommendation as to whether the dose escalation can proceed as planned according to the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Osteodex 3.0 mg/kg | Experimental | Drug: Osteodexformulation: solution for infusion route of administration: intravenous infusion |
| Osteodex 6.0 mg/kg | Experimental | Drug: Osteodexformulation: solution for infusion route of administration: intravenous infusion |
| Osteodex 9.0 mg/kg | Experimental | Drug: Osteodexformulation: solution for infusion route of administration: intravenous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥18 years at the time of signing the informed consent form
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
- Evidence of disease progression based on changes in metastatic bone disease (≥2 bone lesions compared to a prior examination) in bone scan and/or other imaging modality AND/OR evidence of PSA progression in the three consecutive determinations at minimum of 1 week intervals
- Castrate level of serum testosterone ≤1.7 nmol/L
- Performance status ECOG 0-2
Key exclusion criteria (7 listed)
- Concurrent use of other anti-cancer agents or treatments, with the following exception: a stable dose of Luteinizing Hormone-Releasing Hormone (LHRH) agonist/antagonist or polyestradiol phosphate. Washout period: bicalutamide 6 weeks; flutamide 4 weeks; abiraterone / enzalutamide 6 weeks, chemotherapy 4 weeks; Radium-223 4 weeks; Strontium-89 or Samarium-153 6 months.
- Any treatment modalities involving palliative radiation therapy or major surgery within 4 weeks prior to treatment in this study
- Simultaneous participation in any other study involving investigational drugs or having participated in a study less than 4 weeks prior to start of study treatment
- Any condition, including the presence of laboratory abnormalities, which confounds the ability to interpret data from the study or places the patient at unacceptable risk if he participates in the study
- Known brain metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OsteodexAlso: ODXformulation: solution for infusion route of administration: intravenous infusion | Drug | Osteodex 3.0 mg/kg, Osteodex 6.0 mg/kg, Osteodex 9.0 mg/kg |
Primary outcome
Relative change from baseline in response markers related to bone metabolism (B-ALP and S P1NP).
Time frame: Baseline and 20 weeks of treatment
19 secondary outcomes
Progression free survival, defined as the time from study entry to the date of disease progression or death from any cause.
Time frame: Baseline, 20 weeks of treatment and long-term follow-up up to 24 weeks
Overall survival, defined as the time from randomisation to the date of death from any cause.
Time frame: Baseline, 20 weeks of treatment and long-term follow-up up to 24 weeks
Change from baseline in response markers related to bone metabolism (B-ALP and S P1NP) at each time point sampled (except 12 weeks).
Time frame: Baseline and 20 weeks of treatment
Change from baseline in response markers related to bone metabolism (Serum C-Terminal Telopeptide (S-CTX) and osteocalcin) at each time point sampled.
Time frame: Baseline and 20 weeks of treatment
Change from baseline in Prostate Specific Antigen (PSA) at each time point sampled.
Time frame: Baseline and 20 weeks of treatment
Time to PSA progression
Time frame: Baseline and 20 weeks of treatment
Time to ALP progression
Time frame: Baseline and 20 weeks of treatment
Time to P1NP progression
Time frame: Baseline and 20 weeks of treatment
Time to progression in bone
Time frame: Baseline and 20 weeks of treatment
Time to progression in soft tissue
Time frame: Baseline and 20 weeks of treatment
Use of analgesics as reported by the patient during treatment and follow-up
Time frame: Baseline, 20 weeks of treatment and long-term follow-up up to 24 weeks
Therapy response based on changes from baseline according to Response Evaluation Criteria In Solid Tumors (RECIST) based on diagnostic CT in patients with measurable soft tissue metastases.
Time frame: Baseline and 20 weeks of treatment
Changes from baseline in bone metastasis by means of bone scan at each time point examined.
Time frame: Baseline and 20 weeks of treatment
Occurrence of symptomatic skeletal events
Time frame: Baseline, 20 weeks of treatment and long-term follow-up up to 24 weeks
Pain (FACT-P questionnaire)
Time frame: Baseline and 20 weeks of treatment
Pain (EQ-5D-5L questionnaire)
Time frame: Baseline and 20 weeks of treatment
Quality of life (EQ-5D-5L questionnaire)
Time frame: Baseline and 20 weeks of treatment
Incidence, causality and intensity of Adverse Events (AEs)
Time frame: Baseline, 20 weeks of treatment and long-term follow-up up to 24 weeks
Dose and duration of medications required for the treatment of AEs
Time frame: Baseline, 20 weeks of treatment and long-term follow-up up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Derived from this study: PubMed 36682096Thellenberg-Karlsson C, Vjaters E, Kase M, Tammela T, Ojamaa K, Norming U, Nyman C, Andersson SO, Hublarovs O, Marquez-Holmberg M, Castellanos E, Ullen A, Holmberg A, Nilsson S. A randomised, double-blind, dose-finding, phase II multicentre study of ODX in the treatment of patients with castration-resistant prostate cancer and skeletal metastases. Eur J Cancer. 2023 Mar;181:198-207. doi: 10.1016/j.ejca.2022.12.006. Epub 2022 Dec 20.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Holmberg, MD study director
DexTech Medical AB
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Osteodex in people with Prostate Cancer Metastatic, run by DexTech Medical AB at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Sweden, Estonia, Latvia, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative change from baseline in response markers related to bone metabolism (B-ALP and S P1NP). (time frame: Baseline and 20 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02825628, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.