Testosterone Revival Abolishes Negative Symptoms, Fosters Objective Response and Modulates Enzalutamide Resistance

Completed · Phase 2

Conditions studied: Castration Resistant Metastatic Prostate Cancer

In brief

Asymptomatic men with progressive metastatic Castration-resistant prostate cancer (CRPC) post- treatment with abiraterone acetate (pre-chemotherapy for metastatic disease) will be treated on a randomized, multi-Institutional open label study to determine if treatment with intramuscular T given on a dose/schedule designed to result in rapid cycling from the polar extremes of supraphysiologic to near castrate levels \[i.e. Bipolar Androgen Therapy (BAT)\] will improve primary and secondary objectives vs. enzalutamide as standard therapy.

Key facts

Study ID

NCT02286921

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

222

Starts

2015-01-01

Expected to finish

2020-02-21

Last updated by the study team

2020-11-06

Who can join

Age: 18 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Eastern Cooperative Oncology Group Performance status ≤2
• Age ≥18 years
• Histologically-confirmed adenocarcinoma of the prostate
• Treated with continuous androgen ablative therapy (either surgical castration or luteinizing hormone-releasing hormone agonist/antagonist)
• Documented castrate level of serum testosterone (<50 ng/dl)
• Metastatic disease radiographically documented by CT/MRI or bone scan.
• Must have had disease progression while on abiraterone acetate alone or abiraterone acetate in combination with other investigational agents based on:
• Prostate-specific antigen progression defined as an increase in Prostate-specific antigen, as determined by 2 separate measurements taken at least 1 week apart
• And/Or
• Radiographic disease progression, based on RECIST 1.1 in patients with measurable soft tissue lesions, or PCWG2 for patients with bone disease
• Screening Prostate-specific antigen must be ≥ 1.0 ng/mL.
• Prior treatment with additional second line hormone therapies is allowed.
• No prior treatment with enzalutamide, Apalutamide (ARN-509), Darolutamide (ODM-201), galeterone or other investigational androgen receptor targeted treatment is allowed.
• Prior docetaxel for hormone-sensitive prostate cancer is permitted if ≤ 6 doses were given in conjunction with first-line androgen deprivation therapy and >12 months since last dose of docetaxel.
• Prior treatment with Provenge vaccine and 223Radium (Xofigo) is allowed if >4 weeks from last dose.
• Patients must be withdrawn from abiraterone for ≥ 2 weeks.
• Patients must be weaned off prednisone and be off therapy for ≥ 1 week prior to starting therapy.
• Acceptable liver function:
• Bilirubin < 2.5 times institutional upper limit of normal (ULN)
• aspartate aminotransferase (SGOT) and alanine aminotransferase (SGPT) < 2.5 times ULN
• Acceptable renal function:
• Serum creatinine < 2.5 times ULN
• Acceptable hematologic status:
• Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 (1.5 ×109/L)
• Platelet count ≥ 100,000 platelet/mm3 (100 ×109/L)

You may not qualify if…

• Pain due to metastatic prostate cancer requiring treatment intervention.
• Eastern Cooperative Oncology Group Performance status ≥3
• Prior treatment with enzalutamide is prohibited
• Prior treatment with docetaxel or cabazitaxel for metastatic castration-resistant prostate cancer is prohibited.
• Requires urinary catheterization for voiding due to obstruction secondary to prostatic enlargement well documented to be due to prostate cancer or benign prostatic hyperplasia (BPH).
• Evidence of disease in sites or extent that, in the opinion of the investigator, would put the patient at risk from therapy with testosterone (e.g. femoral metastases with concern over fracture risk, severe and extensive spinal metastases with concern over spinal cord compression, extensive liver metastases)
• Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study
• Active uncontrolled infection, including known history of HIV/AIDS or hepatitis B or C.
• Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
• Patients receiving anticoagulation therapy with Coumadin are not eligible for study. [Patients on non-coumadin anticoagulants (Lovenox, Xarelto, etc.) are eligible for study. Patients on Coumadin who can be transitioned to lovenox prior to starting study treatments will be eligible].
• Patients with prior history of a thromboembolic event within the last 12 months that is not being treated with systemic anticoagulation are excluded.
• Patients allergic to sesame seed oil or cottonseed oil are excluded.
• Major surgery (eg, requiring general anesthesia) within 3 weeks before screening, or has not fully recovered from prior surgery (ie, unhealed wound). Note: subjects with planned surgical procedures to be conducted under local anesthesia may participate.

Where it is running

• Unversity of Alabama — Birmingham, Alabama, United States
• City of Hope — Duarte, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
• Piedmont Cancer Institute — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• University of Kansas Cancer Center — Kansas City, Kansas, United States
• Tulane University Medical Center — New Orleans, Louisiana, United States
• University of Maryland — Baltimore, Maryland, United States
• SKCCC at Johns Hopkins — Baltimore, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Neraska Cancer Specialists — Omaha, Nebraska, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Allegheny Health Network — Pittsburgh, Pennsylvania, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• University of Washing — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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