Metastatic Castration-resistant Prostate Cancer Clinical Trial
Official title:
A Single Arm Open-label, Phase II Study of Sipuleucel-T With Bipolar Androgen Therapy in Men With Metastatic Castration-resistant Prostate Cancer
Verified date | January 2024 |
Source | Yale University |
Contact | Maxime Oriol |
Phone | 2037856497 |
maxime.oriol[@]yale.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an open-label, single-arm phase II study of bipolar androgen therapy (BAT) given in addition with standard of care Sipuleucel-T to determine the interferon (IFN) gamma Enzyme-linked Immunospot (ELISPOT) response rate to PA2024 (an engineered fusion protein of prostatic acid phosphatase and granulocyte-macrophage colony-stimulating factor which the activated autologous dendritic cells in the Sipuleucel-T vaccine are loaded with) in patients with metastatic castration resistant prostate cancer (mCRPC).
Status | Recruiting |
Enrollment | 26 |
Est. completion date | March 2028 |
Est. primary completion date | December 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Written informed consent obtained prior to the initiation of study procedures. - Patients who meet the US FDA-approved indication for Sipuleucel-T: for asymptomatic or minimally symptomatic mCRPC at the discretion of the treating investigator. - Histologically confirmed adenocarcinoma of the prostate. - Metastatic disease as evidenced by soft tissue and/or bony metastases on baseline bone scan and/or computed tomography (CT) scan or Magnetic Resonance Image (MRI). - Castration-resistant prostate cancer (CRCP): Participants must have current or historical evidence of disease progression concomitant with surgical or medical castration, as demonstrated by (a) PSA progression, or (b) progression of measurable disease, or (c) progression of non-measurable disease as defined below: 1. By PSA: two consecutively rising PSA values, at least 7 days apart, each = 1.0 ng/mL and = 50% above the minimum PSA observed during castration therapy or above the pre-treatment value if there was no response. 2. By measurable disease: Progressive disease by RECIST v1.1 criteria 3. By non-measurable disease i. Soft tissue disease: The appearance of 1 or more new lesions, and/or unequivocal worsening of non-measurable disease when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response. ii. Bone disease: Appearance of 2 or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response. Increased uptake of pre-existing lesions on bone scan does not constitute progression. - Progressive disease (as defined in section 9.1.4) during the immediately past therapy must be documented prior to enrollment. - Castration status confirmed by serum testosterone level <50ng/dL - ECOG Performance Status of 0 or 1. - Adequate liver function: 1. Bilirubin <2.0 x institutional upper limit of normal (UNL) 2. AST (SGOT) <2.5 x UNL 3. ALT (SGPT) <2.5 x UNL - Acceptable renal function a) Serum creatinine <2.0 x UNL - Acceptable hematologic function: 1. Absolute neutrophil count (ANC) > 1.0 x10^9 cells /L) 2. Platelet counts > 100 x 10^9 / L) 3. Hemoglobin >9 g/dL Exclusion Criteria: - PSA >20ng/dL within the 4 weeks prior to signing ICF - Previously treated with three or more FDA-approved androgen/AR signaling inhibitors (ASI) (e.g., abiraterone, enzalutamide, apalutamide, darolutamide). No minimum number of ASI is required. - Prior chemotherapy for mCRPC. However, prior chemotherapy administered for mCSPC is allowed unless the disease progression to CRPC occurred within 12 months from the last dose of chemotherapy. - Prior treatment with Sipuleucel-T or supraphysiologic dose of testosterone treatment for prostate cancer. - Prior systemic treatment with ASI, PARP inhibitor or Radium-223 or other systemic anti-cancer therapy for prostate cancer within 4 weeks prior to eligibility confirmation. - Prior prednisone >10mg (or its equivalent) within 2 weeks prior to registration. - Prior immunotherapy or Lu177 PSMA radioligand therapy within 6 weeks prior to registration. - Prior palliative radiotherapy within 2 weeks prior to registration. - Radiographic evidence of hepatic metastases - Use of narcotics including tramadol or stronger for cancer-related pain within 4 weeks prior to signing ICF. Use of NSAIDs or acetaminophen is allowed. - Active autoimmune disease requiring systemic corticosteroids of prednisone greater than 10mg a day or the equivalent dose of other corticosteroids. - Known HIV, Hepatitis B or Hepatitis C or Human T cell Lymphotropic virus (HTLV)-1 infection. Testing is not required. - Active infection requiring parenteral antibiotic therapy or causing fever (temperature >100.5 in Fahrenheit scale) within 1 week prior to registration. - Life expectancy of less than 6 months prior to signing ICF. - Any medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives. |
Country | Name | City | State |
---|---|---|---|
United States | Yale Cancer Center | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | Dendreon |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the immune response to PA2024 with BAT and Sipuleucel-T | As measured by ELISPOT from blood samples in pg/ml | Through the study completion, average 12 months | |
Secondary | To determine antigen presenting cell (APC) cumulative activation | as assessed by flow cytometry staining and defined as the increase in surface CD54 on APCs, expressed as an upregulation ratio of the average number of molecules on after culture versus before culture cells from the sipuleucel-T product from blood samples in pg/ml | Through the study completion, average 12 months | |
Secondary | To determine APC number | as assessed by flow cytometry staining from each sipuleucel-T product. from blood samples in pg/ml | Through the study completion, average 12 months | |
Secondary | To determine total nucleated cell count | as assessed by flow cytometry staining from each sipuleucel-T product. from blood samples in pg/ml | Through the study completion, average 12 months | |
Secondary | To determine T cell proliferation to PA2024 | As measured by ELISPOT from blood samples in pg/ml | Through the study completion, average 12 months | |
Secondary | To determine T cell proliferation to Prostatic Acid Phosphatase (PAP) | As assessed by tritiated thymidine uptake from blood samples | Through the study completion, average 12 months | |
Secondary | To determine ex vivo cytokine profiles with BAT + Sipuleucel-T | As assessed via Luminex assay from blood samples in pg/ml | Through the study completion, average 12 months | |
Secondary | To determine humeral response with BAT + Sipuleucel-T | As assessed by ELISA from blood samples in pg/ml | Through the study completion, average 12 months | |
Secondary | To determine PSA50 response rate to BAT + Sipuleucel-T | As defined by PSA decline > 50% from baseline at any point | Through the study completion, average 12 months | |
Secondary | To determine objective response rate (ORR) to BAT + Sipuleucel-T | As defined by RECIST v1.1 criteria | Through the study completion, average 12 months | |
Secondary | To estimate radiographic progression free survival (rPFS) | Defined as the time interval from registration to the first occurrence of radiographic progression by Tc99 Bone Scan using PCWG3 criteria or radiographic soft tissue progression by RECIST v1.1 or death from any cause, whichever occurs first. | From the date of registration until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 5 years | |
Secondary | To estimate overall survival (OS) | Defined as the time interval from registration to death due to any cause | From the date of registration until the date of death from any cause, assessed up to 5 years | |
Secondary | To assess safety and tolerability to BAT+ Sipuleucel-T | As assessed by using CTCAE version 5.0 | Through the study completion, average 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04986423 -
ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Terminated |
NCT05489991 -
A Study of TmPSMA-02 Chimeric Antigen Receptor (CAR) T-cells in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT05521412 -
EValuation of radIOLigand Treatment in mEn With Metastatic Castration-resistant Prostate Cancer With [161Tb]Tb-PSMA-I&T
|
Phase 1/Phase 2 | |
Terminated |
NCT04556617 -
PLX2853 in Combination With Abiraterone Acetate and Prednisone and in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
|
Phase 1/Phase 2 | |
Completed |
NCT02125357 -
Sequencing Abiraterone and Enzalutamide in mCRPC
|
Phase 2 | |
Recruiting |
NCT05917470 -
A Clinical Study of ONCT-534 in Subjects With Metastatic Castration-resistant Prostate Cancer.
|
Phase 1/Phase 2 | |
Recruiting |
NCT06052306 -
A Study to Learn How Safe the Study Treatment Actinium-225-macropa-pelgifatamab (BAY3546828) is, How it Affects the Body, How it Moves Into, Through and Out of the Body, and About Its Anticancer Activity in Men With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC)
|
Phase 1 | |
Recruiting |
NCT05519449 -
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
|
Phase 1 | |
Terminated |
NCT05301062 -
A Research Called CREDIT Studies How Safe the Study Treatment Radium-223 is and How Well it Works in Chinese Men With Advanced Prostate Cancer That Has Spread to the Bones and Does Not Respond to Treatments for Lowering Testosterone Levels
|
||
Recruiting |
NCT05383079 -
Combination of Radium-223 and Lutetium-177 PSMA-I&T in Men With Metastatic Castration-Resistant Prostate Cancer
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04060394 -
Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib Patients With m-CRPC
|
Phase 1/Phase 2 | |
Completed |
NCT01942837 -
Study of Enzalutamide in Patients With Castration-resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05458544 -
[Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application
|
Phase 1/Phase 2 | |
Withdrawn |
NCT04879589 -
Phase 1 Study of ATRS-2002 in Healthy Male Adults
|
Phase 1 | |
Recruiting |
NCT03230734 -
Sequencing of Radium-223 and Docetaxel in Symptomatic Bone-only Metastatic Castration-resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05116579 -
Circulating Tumor DNA (ctDNA) Monitoring in the Assessment and Prediction of the Efficacy of PARP Inhibitors (PARPi)
|
||
Active, not recruiting |
NCT03732820 -
Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer
|
Phase 3 | |
Recruiting |
NCT05005728 -
XmAb®20717 (Vudalimab) Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05762536 -
Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC
|
Phase 2 |