Metastatic Castration Resistant Prostate Cancer (CRPC) and skeletal metastases MedDRA version: 19.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
DexTech Medical AB
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Age =18 years at the time of signing the informed consent form 2. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate 3. 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 4. Evidence of PSA progression in three consecutive determinations at minimum 1 week intervals 5. Castrate level of serum testosterone =1.7 nmol/L 6. Performance status ECOG 0-2 7. Laboratory requirements: 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 8. No evidence (= 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin) 9. Able to adhere to the study visit schedule and other protocol requirements 10. Life expectancy =6 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Concurrent use of other anti-cancer agents or treatments, with the following exception: a stable dose of 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. 2. Any treatment modalities involving palliative radiation therapy or major surgery within 4 weeks prior to treatment in this study 3. 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 4. 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 5. Known brain metastases 6. Dental surgery (dental extraction), periodontal disease, local trauma including poorly fitting dentures within 6 months prior to the first dose of study drug 7. Treatment with bisphosphonates or denosumab within 4 weeks prior to first dose of study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the relative change from baseline in response markers related to bone metabolism (B-ALP and S P1NP) at 12 weeks of three different doses of ODX (3.0, 6.0 and 9.0 mg/kg ODX).;Secondary Objective: The secondary objectives of this study are to compare the effects of three different doses of ODX plus best standard of care on the following: • progression free survival • overall survival • change in response markers related to bone metabolism (B-ALP and S-P1NP) at each timepoint except 12 weeks. • change in response markers related to bone metabolism (S-CTX and osteocalcin) at each timepoint sampled. • change in PSA • time to PSA, ALP and P1NP progression • pain (FACT-P and EQ-5D-5L questionnaire) • analgesic consumption • therapy response based on changes in tumor cell metabolism according to RECIST measured with CT. • changes from baseline in bone metastasis by means of bone scan at each time point examined. • occurrence of symptomatic skeletal events (SSEs; clinically significant pathological fracture, radiation therapy to bone, surgery to bone, or spinal cord compression) • safety, tolerability and quality of life (FACT-P and EQ-5D-5L questionnaire) ;Primary end point(s): Relative change from baseline in response markers related to bone metabolism (B-ALP and S-P1NP) at 12 weeks of three different doses of ODX (3.0, 6.0, 9.0 mg/kg ODX).;Timepoint(s) of evaluation of this end point: A DMC (Data Monitoring Committee) will be established to review unblinded study information during the conduct of the study. Based on its review the DMC will provide the sponsor with recommendations regarding study modification, continuation or termination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Progression free survival, defined as time from randomization until disease progression or death from any cause • Overall survival, defined as the time from randomization to the date of death from any cause • Change from baseline in response markers related to bone metabolism (B-ALP and S-P1NP) at each time point sampled (except 12 weeks) • Change from baseline in response markers related to bone metabolism (S-CTX and osteocalcin) at each time point sampled • Change from baseline in PSA at each time point sampled • Time to PSA progression (defined as =25% increase from baseline and an absolute value increase =2 ng/mL at =12 weeks [in patients with no PSA decline from baseline] or =25% increase and an absolute value increase =2 ng/mL above nadir which is confirmed by a second value 3 or more weeks later [in patients with an initial PSA decline from baseline]) • Time to ALP progression (defined as =25% increase from baseline at =12 weeks from baseline [in patients with no total ALP decline from baseline] or =25% increase above the nadir value which is confirmed by a second value 3 or more weeks later [in patients with an initial total ALP decline from baseline]) • Time to P1NP progression (defined as =25% increase from baseline at =12 weeks from baseline [in patients with no total P1NP decline from baseline] or =25% increase above the nadir value which is confirmed by a second value 3 or more weeks later [in patients with an initial total P1NP decline from baseline]) • Time to progression in bone • Time to progression in soft tissue • Pain (FACT-P and EQ-5D-5L questionnaire) • Analgesic consumption • Therapy response based on changes from baseline according to RECIST criteria based on diagnostic CT in patients with measurable soft tissue metastases • Change from baseline in bone metastasis by means of bone scan (progression in bone will be defined as at least two or more new lesions on bone scan compared with prior scan at trial | — |
Countries
Estonia, Finland, Latvia, Sweden
Contacts
Public ContactPublic Relations Director
DexTech Medical AB
Outcome results
None listed