Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer (NCT03511196) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer
United States17 participantsStarted 2018-09-17
Plain-language summary
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).
Who can participate
Age range18 Years
SexMALE
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Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the prostate.
* \>75% prostate specific antigen (PSA) decline after 12 to 16 weeks of run in period with Gonadotropin-releasing Hormone (GnRH) analog abiraterone plus prednisone.
* Performance status Eastern Cooperative Oncology Group (ECOG) 0-1
* Adequate organ function Serum alanine aminotransferase (ALT) or aspartate 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 GnRH analog with GnRH analogue for non-metastatic prostate cancer within 12 months prior to study enrollment or \>3 months of GnRH analog in the metastatic setting
* Prior treatments with TAK-700/Orteronel, 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 dru…
What they're measuring
1
Rate of Participant Retention
Timeframe: 12 months from participant's first dose of ADT
Trial details
NCT IDNCT03511196
SponsorH. Lee Moffitt Cancer Center and Research Institute