Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer (NCT05751941) | Clinical Trial Compass
RecruitingPhase 2
Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer
United States26 participantsStarted 2023-02-14
Plain-language summary
This study is designed to test the hypothesis that using Sipuleucel-T (Provenge) in combination with new hormonal agents (NHA) (abiraterone, enzalutamide, apalutamide) for the treatment of participants with asymptomatic metastatic castration resistant prostate cancer (mCRPC) and no visceral metastases would enhance the activation of antigen presenting cells (APC) by sipuleucel-T.
Who can participate
Age range18 Years
SexMALE
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Inclusion Criteria:
* Asymptomatic or minimally symptomatic metastatic prostate cancer, and the diagnosis of prostate cancer needs to be histologically confirmed by biopsy of the prostate or a metastatic lesion
* On combined ADT with LHRH analog and a NHA (enzalutamide, apalutamide or abiraterone) for metastatic prostate cancer with PSA progression, but no imaging progression based on the prostate cancer working group (PCWG) 3 criteria
* Age 18 or above
* ECOG performance status 0 or 1
* Participants must have adequate organ and marrow function as defined below:
* Absolute neutrophil count ≥1,000/mcL
* Platelets ≥100,000/mcL
* Hemoglobin \> 10 g/dl
* AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
* Creatinine 1.5 ≤ institutional ULN
* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of sipuleucel-T are eligible for th…
What they're measuring
1
Cumulative APC Activation
Timeframe: At Week 4
Trial details
NCT IDNCT05751941
SponsorH. Lee Moffitt Cancer Center and Research Institute