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Phase 2 N=211 Randomized Treatment

Bicalutamide and Goserelin or Leuprolide Acetate With or Without Cixutumumab in Treating Patients With Newly Diagnosed Metastatic Prostate Cancer

Prostate Adenocarcinoma · Recurrent Prostate Carcinoma · Stage IV Prostate Cancer

Enrolled (actual)
211
Serious AEs
6.8%
Results posted
Oct 2016
Primary outcome: Primary: Undetectable PSA Rate — 42; 34 participants — p=0.16

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Bicalutamide (Drug); Cixutumumab (Biological); Goserelin Acetate (Drug); Laboratory Biomarker Analysis (Other); Leuprolide Acetate (Drug); Pharmacological Study (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
Male
Sponsor
National Cancer Institute (NCI)
Primary completion
Jun 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Undetectable PSA Rate
42; 34 0.16
SECONDARY
Toxicity
1; 0; 1; 1; 0; 1
SECONDARY
Proportion of Patients Who do Not Achieve a Partial PSA Response
46; 56 0.11
SECONDARY
Accuracy of the Prognostic Model of Undetectable PSA (Developed From SWOG-9346)
SECONDARY
Correlation of microRNA Measures With 28-week PSA Response
32.6; 32.0; 31.5; 34.5; 33.8; 33.8
SECONDARY
Correlation of microRNA Measures With Baseline Circulating Tumor Cell (CTC) Counts
33.0; 32.7; 31.9; 34.4; 34.7; 33.0
SECONDARY
Change in Level of CTCs
12; 5; 4; 0; 2; 3

Summary

This randomized phase II trial is studying bicalutamide, goserelin, or leuprolide acetate to see how well they work when given with or without cixutumumab in treating patients with newly diagnosed metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, goserelin, or leuprolide acetate, may lessen the amount of androgens made by the body. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether bicalutamide, goserelin, or leuprolide acetate are more effective when given with or without cixutumumab in treating prostate cancer.

Eligibility Criteria

Inclusion Criteria

  • All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate; note: If there is no formal biopsy report documenting the diagnosis of prostate cancer, the patient can be allowed on trial if the PSA level is at least 20, and there are at least three definitive metastatic lesions seen on scan; all patients must have had metastatic (M1) disease as evidenced by soft tissue and/or bony metastases prior to androgen deprivation therapy initiation; patients must have at least one of the following at the time they started androgen deprivation therapy:
  • Visceral disease (liver, lung, or other viscera)
  • Bone metastases to sites in either the axial (spine, pelvis, ribs, or skull) and/or the appendicular (clavicle, humerus, or femur) skeleton
  • Lymph node disease not considered to be encompassed within a single radiotherapy port (e.g., above the aortic bifurcation, etc.)
  • Patients who have measurable disease must have radiographic assessment (at least an abdominal/pelvic computed tomography [CT]) within 28 days prior to registration; non-measurable disease must also be assessed (e.g., bone scan) in all patients within 56 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form
  • Patients must have a PSA >= 5 ng/mL obtained within 90 days prior to initiation of androgen deprivation therapy
  • Patients with known brain metastases are not eligible; brain imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms, but if brain imaging studies are performed, they must be negative for disease
  • Patient must have had no more than 30 days of prior medical castration for metastatic prostate cancer (prior androgen deprivation therapy is allowed if it was received with curative intent in the neoadjuvant, concurrent, and/or adjuvant fashion and at least 2 years have elapsed since completion of androgen deprivation therapy); the start date of medical castration is considered the day the patient first received an injection of a LHRH agonist, not an oral antiandrogen; if the method of castration is luteinizing hormone releasing hormone (LHRH) agonists (i.e., leuprolide or goserelin), the patient must be willing to continue the use of LHRH agonists and add bicalutamide for combined androgen deprivation therapy (ADT) during protocol treatment; the 30 day window begins from the date of receiving the LHRH agonist, not the oral antiandrogen; if the patient was on a different antiandrogen (e.g. flutamide), the patient must be willing to switch over to bicalutamide; patients must not have received bilateral orchiectomy; patients must not have received or be planning to receive LHRH antagonists (i.e., Degarelix); however, if the patient was initiated on a LHRH antagonist within the 30 day window and is willing to switch to a LHRH agonist with bicalutamide, he may enroll on the late induction group
  • Patients who have not already started androgen deprivation therapy must be offered the opportunity to participate in the translational medicine studies; once a patient has started any form of antiandrogen (i.e., either bicalutamide or LHRH agonist), he is not eligible for any translational medicine studies
  • Patients must not have received any prior cytotoxic chemotherapy for metastatic prostate cancer; prior cytotoxic chemotherapy with curative intent in the neoadjuvant or adjuvant setting is allowed; patients must not have received any prior treatment with agents that directly inhibit IGF or IGFRs
  • Patients must not have received prior strontium-89, rhenium-186, rhenium-188, or samarium-153 radionuclide therapy within 28 days prior to registration
  • Patients may have received prior radiation therapy or biologic therapy (e.g. vaccines, immunotherapy, anti-sense, small molecules, monoclonal antibodies); however, at least 28 days must have elapsed since completion of therapy and patient must have recover
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01120236). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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