Metastatic Castration Resistant Prostate Cancer (CRPC) MedDRA version: 18.0 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. Failing or not tolerating docetaxel therapy or for other reasons not suitable for such therapy and failing subsequent therapy with abiraterone and/or enzalutamide. 4. Evidence of metastatic disease from bone scan (bone lesions) or other imaging modality. 5. Evidence of PSA progression in two consecutive determinations at minimum 1 week interval. 6. Castrate level of serum testosterone =1.7 nmol/L 7. Performance status ECOG 0-2 8. Laboratory requirements: Haematology: Neutrophils = 1.5 x 109/l Hemoglobin = 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 Renal function: S-creatinine = 1.5 times the upper limit of normal (ULN) Electrolytes: S-sodium, S-potassium, S-calcium (S-albumin corrected), S-phosphate, S-magnesium, all within normal ranges. 9. No evidence (= 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin). 10. Able to adhere to the study visit schedule and other protocol requirements. 11. 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 66 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 66
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 bicalutamide. Washout period bicalutamide 6 weeks; after flutamide 4 weeks; abirateron / enzalutamide 6 weeks. 2. Any treatment modalities involving chemotherapy, radiation 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. Plasma glucose level =7 mmol/l (or >120 mg/dl) at screening. 6. Known brain metastases. 7. Dental surgery (dental extraction), periodontal disease, local trauma including poorly fitting dentures within 6 months prior to the first dose of study drug. 8. Treatment with bisphosphonates 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 of response markers related to bone metabolism (B-ALP and S-P1NP);Secondary Objective: The secondary objectives of this study are to compare the effects of best standard of care plus ODX and best standard of care plus placebo on the following: •overall survival •change in response markers related to bone metabolism (S-CTX and osteocalcin) •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 measured with PET-CT with 18F-fluorodeoxyglucose (FDG). •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 in response markers related to bone metabolism (B-ALP and S-P1NP);Timepoint(s) of evaluation of this end point: Will be assessed at 3 DSMB (Data Safety Monitoring Board) meetings during the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy •Overall survival •Change in response markers related to bone metabolism (S-CTX and osteocalcin) •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]) •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]) •P1NP progression (defined as =30% increase from baseline at =12 weeks from baseline [in patients with no total P1NP decline from baseline] or =30% 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]) •Pain (FACT-P and EQ-5D-5L questionnaire) •Analgesic consumption •Therapy response based on changes in tumor cell metabolism measured with PET-CT with FDG •Changes in bone metastasis by means of bone scan •Occurence of symptomatic skeletal events (SSEs) Safety •Incidence, causality and intensity of AEs •Laboratory tests •Need of medications (dose and duration) to treat AEs •Electrocardiogram (ECG) abnormalities ;Timepoint(s) of evaluation of this end point: Will be assessed at 3 DSMB (Data Safety Monitoring Board) meetings during the study. | — |
Countries
Denmark, Sweden
Contacts
Public ContactPublic Relations Director
DexTech Medical AB
Outcome results
None listed