SHS_211108 PORJ NRUT 17089

SIMCAP (Surgery in Metastatic Carcinoma of Prostate): Phase 2.5 Multi-Institution Randomized Prospective Clinical Trial Evaluating the Impact of Cytoreductive Radical Prostatectomy Combined With Best Systemic Therapy on Oncologic and Quality of Life Outcomes in Men With Newly Diagnosed Metastatic Prostate Cancer

Inclusion Criteria:

• Histologically proven adenocarcinoma of the prostate

• Evidence of metastasis by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histologic confirmation

• Clinical stage M1a (distant lymph node positive), or M1b (bone metastasis)

• If solitary lesion, metastasis confirmed with either biopsy or two independent imaging modalities (i.e. CT and PET [positron emission tomography], bone scan and MRI, modality at the discretion of the treating physician)

• No previous local therapy for prostate cancer

• Give informed consent

• Prostate deemed resectable by surgeon

• Started antiandrogen therapy (ADT) no longer than 6 months prior to randomization

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Hemoglobin (HgB) >= 9 g/dL compatible for surgery

• Platelets > 80,000 compatible for surgery

• Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) =< 2x upper limit of normal (ULN) compatible for surgery


Exclusion Criteria:

• Refuses to give informed consent

• Deemed to have unresectable disease by surgeon

• Received ADT for more than 6 months prior to randomization

• Life expectancy of less than 6 months prior to randomization

• Known spinal cord compression

• M1c disease (solid organ metastasis)

• Deep vein thrombosis (DVT) / pulmonary embolism (PE) in the past 6 months prior to randomization

• Previous local therapy for prostate cancer

• Previous chemotherapy for prostate cancer

• Patients who have chemotherapy, radiotherapy or oral antifungal agents (ketoconazole, itraconazole, fluconazole) within 3 weeks prior to entering the study or those who have not recovered (e.g. back to baseline or grade 1) from adverse events due to agents administered more than 3 weeks earlier

• Any drug interactions that are deemed to be medically significant would require a washout of 5-half-lives of the interaction agent before enrollment can occur
Phase II
NCT03456843
All Other, Cancer
Genitourinary
James Porter, M.D.
Rutgers
Adel Islam
  • Swedish Medical Center