Prostate Cancer | Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer
Prostate Cancer research study
What is the primary objective of this study?
This Phase 3 study has been designed to confirm that adding custirsen to cabazitaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard cabazitaxel/prednisone treatment in men with metastatic castrate resistant prostate cancer (CRPC). This will be a randomized, open-label, multicenter, international trial. Treatment will consist of cabazitaxel/prednisone/custirsen vs. cabazitaxel/prednisone. A total of approximately 630 patients will be randomized with equal probability to the two arms.
Who is eligible to participate?
Inclusion Criteria: - Histological or cytological diagnosis of adenocarcinoma of the prostate - Metastatic disease on chest, abdominal, or pelvic CT scan and/or bone scan - Previous first-line treatment for CRPC with a docetaxel-containing regimen - Current progressive disease - Increasing serum PSA level (for patients who progress based only on increasing serum PSA level, a minimum starting value of 5.0 ng/mL is required) - Baseline laboratory values as defined - Willing to continue primary androgen suppression with gonadotropin-releasing hormone (GnRH) analogues (unless treated with bilateral orchiectomy) - Karnofsky score ≥70% - At least 21 days have passed since completing radiotherapy - At least 21 days have passed since receiving any investigational agent at the time of randomization - At least 21 days have passed since major surgery - Recovered from any docetaxel therapy-related neuropathy to ≤grade 1 at the time of randomization - Recovered from all therapy related toxicity to ≤grade 2 (except alopecia, anemia, and any signs or symptoms of androgen deprivation therapy) at the time of randomization - Able to tolerate a starting dose of 25 mg/m² cabazitaxel - Willing to not add, delete, or change current bisphosphonate or denosumab usage - Able to tolerate oral prednisone at 10 mg per day - Competent to provide written informed consent Exclusion Criteria: - Received any other cytotoxic chemotherapy beyond the first-line docetaxel-containing regimen as treatment for prostate cancer - Received prior radioisotope with strontium 89 or samarium 153 - Received any cycling, intermittent, or continuous hormonal treatment within 21 days prior to randomization with the exception of the continuous GnRH analogues (prior treatment with abiraterone or MDV3100 is allowed as long as 21 days have passed since last dose) - Participated in a prior Phase 3 clinical study evaluating custirsen regardless of study arm assignment - Requiring ongoing treatment during the study with medications known to be either strong CYP3A inhibitors or strong CYP3A inducers - History of or current documented brain metastasis or carcinomatous meningitis, treated or untreated - Current symptomatic cord compression requiring surgery or radiation therapy - Active second malignancy (except non melanomatous skin or superficial bladder cancer) defined in general as requiring anticancer therapy or at high risk of recurrence during the study - Uncontrolled medical condition or significant concurrent illness that in the opinion of the Investigator would preclude protocol therapy - Known severe hypersensitivity to taxanes or polysorbate 80-containing drugs - Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:cabazitaxelCabazitaxel (25mg/m² IV) is administered on day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or completion of 10 cycles
Drug:prednisonePrednisone (10 mg PO) is administered daily until disease progression, unacceptable toxicity, or completion of 10 cycles
Drug:custirsen sodiumCustirsen is administered as 3 loading doses (640 mg IV each) within 9 days, followed by weekly custirsen (640 mg IV) during each 21-day cycle until disease progression, unacceptable toxicity, or completion of 10 cycles
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Cabazitaxel plus Custirsencabazitaxel, prednisone, and custirsen sodium
Cabazitaxelcabazitaxel and prednisone
Start Date: August 2012
Completed Date: July 2016
Phase: Phase 3
Primary Outcome: Survival in the intent-to-treat population
Secondary Outcome: Progression-free survival at Day 140
Study sponsors, principal investigator, and references
Principal Investigator: Thomasz Beer, MD
Lead Sponsor: Achieve Life Sciences
Saad F, Hotte S, North S, Eigl B, Chi K, Czaykowski P, Wood L, Pollak M, Berry S, Lattouf JB, Mukherjee SD, Gleave M, Winquist E; Canadian Uro-Oncology Group. Randomized phase II trial of Custirsen (OGX-011) in combination with docetaxel or mitoxantrone as second-line therapy in patients with metastatic castrate-resistant prostate cancer progressing after first-line docetaxel: CUOG trial P-06c. Clin Cancer Res. 2011 Sep 1;17(17):5765-73. doi: 10.1158/1078-0432.CCR-11-0859. Epub 2011 Jul 25.