A Randomized Phase 3 Study Comparing Standard First-Line Docetaxel/Prednisone to Docetaxel/Prednisone in Combination With Custirsen (OGX-011) in Men With Metastatic Castrate Resistant Prostate Cancer
- Conditions
- Prostate CancerC61Malignant neoplasm of prostate
- Registration Number
- DRKS00003891
- Lead Sponsor
- Teva Pharmaceutical Industries
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 1023
Inclusion Criteria
- Age = 18 years on the date of consent.
- Histological or cytological diagnosis of adenocarcinoma of the prostate.
- Metastatic disease on chest, abdominal, or pelvic CT and/or bone scan.
- Systemic chemotherapy indicated due to progression while on or after androgen
ablative therapy defined as:
1. Progressive measurable disease: at least a 20% increase in the sum of the
longest diameters of measurable lesions over the smallest sum observed -or- the
appearance of one or more new lesions as assessed by CT scan during hormone
ablation treatment. Measurable lesions are nodal or visceral soft-tissue lesions
with nodal lesions = 20 mm in diameter or visceral/soft-tissue lesions = 10 mm
in diameter (see Section 6.3.1.1 ).
OR
2. Bone Scan Progression: appearance of 2 or more new lesions on bone scan during
hormone ablation treatment.
OR
3. Increasing serum PSA level: Two consecutive increases in PSA levels documented
over a previous reference value obtained at least one week apart are required.
If the third PSA value is less than the second, an additional fourth test to
confirm a rising PSA is acceptable. A minimum starting value of 5.0 ng/mL is
required for study randomization.
- Baseline laboratory values as stated below:
1. Creatinine = 1.5 x upper limit of normal (ULN).
2. Bilirubin = 1.1 x ULN (unless elevated secondary to conditions such as Gilbert's
disease).
3. SGOT (AST) and SGPT (ALT) = 1.5 x ULN.
4. Castrate serum testosterone level (< 50 ng/dL-or-< 1.7 nmol/L).
- Must be willing to continue primary androgen suppression with gonadotropin-releasing
hormone (GnRH) analogues (either agonists or antagonists) throughout the study,
unless treated with bilateral orchiectomy.
- Adequate bone marrow function defined at screening as ANC = 1.5 x 10^9 cells /L and
platelet count = 100 x 10^9 /L.
- Karnofsky score = 70% (see Appendix 17.2).
- At least 28 days has passed since completing radiotherapy (exception for
radiotherapy: at least 7 days since completing a single fraction of = 800 cGy to a
restricted field or limited-field radiotherapy to non-marrow bearing area such as an
extremity or orbit) at the time of randomization.
- At least 4 weeks have passed since receiving any investigational agent at the time of
randomization.
- Has recovered from any other therapy-related toxicity to = grade 2, (except alopecia,
anemia and any signs or symptoms of androgen deprivation therapy).
- Patient must be willing to not add, delete or change their current bisphosphonate or
denosumab usage throughout study treatment to assure that adverse event reporting is
not confounded by changing their bisphosphonate or denosumab usage (unless withdrawn
or changed as a result of bisphosphonate or denosumab associated toxicity).
- Patients receiving more than 10 mg of prednisone per day (or steroid e
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method