A Study to Compare Docetaxel/Prednisone to Docetaxel/Prednisone Combined with OGX-011 in Men with Prostate Cancer

Overview

About this study

The purpose of this study is to confirm that adding custirsen to standard first-line docetaxel and prednisone treatment can slow tumor progression in men who have prostate cancer, and enhance survival outcomes compared to standard first-line docetaxel and prednisone treatment alone. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

This study has been completed

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
    • Progressive measurable disease of at least a 20% increase in the sum of the longest diameters of measurable lesions over the smallest sum observed 
    • 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 )
    • Bone Scan Progression with the appearance of 2 or more new lesions on bone scan during hormone ablation treatment
    • Increasing serum PSA level with two consecutive increases in PSA levels documented over a previous reference value obtained at least one week apart 
      • 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
    • Creatinine ≤ 1.5 x upper limit of normal (ULN)
    • Bilirubin ≤ 1.1 x ULN (unless elevated secondary to conditions such as Gilbert's disease)
    • SGOT (AST) and SGPT (ALT) ≤ 1.5 x ULN
    • 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%
  • At least 28 days has passed since completing radiotherapy (exception for radiotherapy of 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
  • 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)
  • If receiving more than 10 mg of prednisone per day (or steroid equivalent) at screening must be willing to have the dose reduced to 10 mg of prednisone per day for at least 7 days prior to randomization and maintained throughout study treatment
  • Written informed consent must be obtained prior to any protocol-specific procedures being performed

Exclusion Criteria

  • Received any other cytotoxic chemotherapy as treatment for prostate cancer
  • Received any cycling, intermittent or continuous hormonal treatment 28 days prior to randomization with the exception of the continuous GnRH analogues required in Inclusion Criteria
  • Participated in a prior clinical study evaluating custirsen
  • History of or current documented brain metastasis or carcinomatous meningitis, treated or untreated. (Brain imaging for asymptomatic patients is not required)
  • Current symptomatic cord compression requiring surgery or radiation therapy (Once successfully treated and there has been no progression, patients are eligible for the study)
  • Active second malignancy (except non melanomatous skin or superficial bladder cancer) defined as requiring cancer therapy or at high risk of reoccurrence during the study
  • Uncontrolled medical conditions such as heart failure, myocardial infarction, uncontrolled hypertension, stroke or treatment of a major active infection within 3 months of randomization, as well as any significant concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy
  • Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device
    • Concomitant participation in observational studies is acceptable

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Manish Kohli, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20315396

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