A Pilot Study Of Intermittent Androgen Deprivation Therapy Adapted To Serum Testosterone And PSA Levels For Stage IV Castration Sensitive Prostate Cancer

Condition: Prostate Cancer, Stage IV Prostate Cancer, Advanced Prostate Cancer, Adenocarcinoma of the Prostate


  • Drug: Adaptive Androgen Deprivation Therapy (ADT)
  • Drug: Abiraterone
  • Drug: Prednisone

Purpose: Adaptive Androgen Deprivation Therapy (ADT) plus Standard of Care. The purpose of this study is to develop adaptive therapy for high risk metastatic castration sensitive prostate cancer (mCSPC).

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03511196

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Primary Outcome Measures:

  • Measure: Rate of Participant Retention
  • Time Frame: 12 months from participant’s first dose of ADT
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Median Time to Progression From the First Dose of Androgen Deprivation Therapy (ADT)
  • Time Frame: 12 months from participant’s first dose of ADT
  • Safety Issue:
  • Measure: Median Time to Radiographic Progression From the First Dose of ADT
  • Time Frame: 12 months from participant’s first dose of ADT
  • Safety Issue:

Estimated Enrollment: 12

Study Start Date: May 17, 2018

Phase: Early Phase 1


  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate.
  • High risk mCSPC as defined by the Latitude study5 (≥ 2 of 3 risk factors: Gleason ≥ 8, ≥ 3 bone lesions, or measurable visceral metastases)
  • >75% prostate specific antigen (PSA) decline after 12 weeks of run in period with androgen deprivation therapy (ADT), abiraterone plus prednisone.
  • Performance status Eastern Cooperative Oncology Group (ECOG) 0-1
  • Adequate organ function Serum alanine aminotransferase (ALT) or aspirate aminotransferase (AST) must be < 2.5 x upper limit of normal (ULN), total bilirubin less than 1.5 X ULN, estimated creatinine clearance must be >40 mL/min, absolute neutrophil count (ANC) > 1500/l, hemoglobin above 9 g/dl, platelet count > 100,000/l
  • Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections or major surgery within 28 days prior to study enrollment
  • Ability to give written informed consent

Exclusion Criteria:

  • Prior ADT with GnRH analogue for non-metastatic prostate cancer within 2 years prior to study enrollment.
  • Prior treatments with TAK-700/Orteronel, abiraterone, ketoconazole, apalutamide or enzalutamide.
  • Documented central nervous system metastases or liver metastasis
  • Prior surgical castration
  • Requiring opioids for cancer related pain.
  • Treatment with any investigational compound within 30 days prior to the first dose of study drugs
  • Diagnosis or treatment for another systemic malignancy within 2 years before the first dose of study drugs, or previously diagnosed with another malignancy & have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
  • Uncontrolled hypertension despite appropriate medical therapy (blood pressure of greater than 160 mmHg systolic and 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the Screening period). Note: Patients may be rescreened after adjustments of antihypertensive medications
  • Unstable symptomatic ischemic heart disease, ongoing arrhythmias of Grade > 2 (NCI CTCAE, version 5), New York Association Class III or IV heart failure
  • Known human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C not contained with anti-viral therapy, life threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in investigator’s opinion, potentially interfere with participation in this study.
  • Known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of study drugs, including difficulty swallowing tables.
  • Delayed healing of wounds, ulcers, and/or bone fractures
  • Inability to comply with protocol requirements


  • H. Lee Moffitt Cancer Center and Research Institute
  • Tampa Florida 33612 United States

View trial on ClinicalTrials.gov