A Pilot Feasibility Study of Sipuleucel-T vs. Sipuleucel-T and Low-protein Diet in Patients With Metastatic Castrate-resistant Prostate Cancer (CRPC)

Condition: Prostate Cancer Recurrent

Intervention:

Other: Low protein diet
Other: Control protein diet

Purpose: This is a single-center, randomized, open-label study to assess the feasibility of a low-protein diet intervention in patients with metastatic castrate-resistant prostate cancer (CRPC) who are receiving treatment with sipuleucel-T. Subjects will be randomized (1:1 ratio) to either Arm 1 or Arm 2 (Fig. 1). Arm 1: Subjects randomized to Arm 1 will be treated with sipuleucel-T infusion on Day 1, every two weeks for a total of three infusions. Subjects on this arm will receive a control diet containing 20% protein. Arm 2: Subjects randomized to Arm 2 will be treated with sipuleucel-T infusion on Day 1, every two weeks for a total of three infusions. Subjects on this arm will receive a low-protein diet containing 10% protein. Patients with metastatic, asymptomatic or minimally symptomatic CRPC that has progressed despite androgen deprivation therapy will be eligible for the study. After informed consent eligible patients will be scheduled to receive sipuleucel-T (three infusions two weeks apart) with normal-protein diet vs. low-protein diet. Each cycle will be every 14 days. Diet intervention will commence 1 week prior to the first apheresis (Day -7) and will continue until 10 days after the last infusion of sipuleucel-T (Day +42) (Fig. 2).

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03329742

Sponsor: Indiana University

Primary Outcome Measures:

Measure: Adherence to diet intervention
Time Frame: 6 weeks
Safety Issue:

Secondary Outcome Measures:

Measure: Feasibility of diet intervention
Time Frame: 6 weeks
Safety Issue:
Measure: Feasibility of diet intervention
Time Frame: 6 weeks
Safety Issue:
Measure: Feasibility of diet intervention
Time Frame: 6 weeks
Safety Issue:
Measure: Safety and tolerability of diet intervention combined with sipuleucel-T treatment
Time Frame: 6 weeks
Safety Issue:
Measure: Rate of immune response
Time Frame: 6, 12, and 14 weeks
Safety Issue:
Measure: Progression free survival
Time Frame: 2 years
Safety Issue:
Measure: Overall survival
Time Frame: 2 years
Safety Issue:

Estimated Enrollment: 30

Study Start Date: December 19, 2017

Eligibility:

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

Eligibility Criteria:

Men at least 18 years of age with asymptomatic or minimally symptomatic, metastatic, androgen independent prostate cancer will be recruited for this study. Before the initiation of screening procedures, the patient will undergo the Informed Consent Process which includes signing an Institutional Review Board (IRB)-approved consent form. The subject will subsequently undergo screening assessments to determine if he meets the eligibility criteria for the study.

Inclusion Criteria:

Histologically documented 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 of the chest, abdomen, and pelvis
Androgen independent prostatic adenocarcinoma. Subjects must have current or historical evidence of disease progression concomitant with surgical or medical castration, as demonstrated by PSA progression OR progression of measurable disease OR progression of non-measurable disease as defined below:
PSA: Two consecutive PSA values, at least 14 days apart, each ≥ 5.0 ng/mL and ≥ 50% above the minimum PSA observed during castration therapy or above the pre-treatment value if there was no response.
Measurable disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The change will be measured against the best response to castration therapy or against the pre-castration measurements if there was no response.
Non-measurable disease: 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.
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.
Serum PSA ≥ 5.0 ng/mL
Castration levels of testosterone (< 50 ng/dL) achieved via medical or surgical castration. Surgical castration must have occurred at least 3 months prior to registration. Subjects who are not surgically castrate must be receiving medical castration therapy, have initiated such therapy at least 3 months prior to registration, and continue such therapy until the time of confirmed objective disease progression.
Life expectancy of at least 6 months
Men ≥ 18 years of age
Adequate hematologic, renal, and liver function as evidenced by the following:
White blood cell (WBC) ≥ 2,500 cells/μL
Absolute neutrophil count (ANC) ≥ 1,000 cells/μL
Platelet Count ≥ 100,000 cells/μL
Hemoglobin (HgB) ≥ 9.0 g/dL
Creatinine ≤ 2.0 mg/dL
Total bilirubin ≤ 2 x upper limit of normal (ULN)
Aspartate aminotransaminase (AST, SGOT) ≤ 2.5 x ULN
Alanine aminotransaminase (ALT, SGPT) ≤ 2.5 x ULN

Exclusion Criteria:

The presence of lung, liver, or known brain metastases, malignant pleural effusions, or malignant ascites.
Moderate or severe symptomatic metastatic disease. Subjects who meet either of the following criteria must be excluded:
A requirement for treatment with opioid analgesics for any reason within 28 days prior to registration
Average weekly pain score of 4 or more as reported on the 10-point Visual Analog Scale (VAS) on the Registration Pain Log
Eastern Cooperative Oncology Group (ECOG) performance status > 2
Use of non-steroidal antiandrogens (e.g., flutamide, nilutamide, or bicalutamide) within 6 weeks of registration.
Treatment with chemotherapy within 28 days of registration including subjects who received more than 2 chemotherapy regimens in the metastatic setting at any time prior to registration.
Treatment with any of the following medications or interventions within 28 days of registration:
Systemic corticosteroids; however, use of inhaled, intranasal, and topical steroids is acceptable.
Ketoconazole
High dose calcitriol [1,25(OH)2VitD] (i.e., > 7.0 μg/week)
Any other systemic therapy for prostate cancer (except for medical castration)
Prior treatment with sipuleucel-T (on clinical trial or as part of standard of care)
Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression
Paget’s disease of bone
A history of stage III or greater cancer, excluding prostate cancer. Basal or squamous cell skin cancers must have been adequately treated and the subject must be disease-free at the time of registration. Subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for ≥ 3 years at the time of registration.
A requirement for systemic immunosuppressive therapy for any reason
Any infection requiring parenteral antibiotic therapy or causing fever (temperature > 100.5°F or 38.1°C) within 1 week prior to registration
A known allergy, intolerance, or medical contraindication to receiving the contrast dye required for the protocol-specified CT imaging
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

Contact:

Marietta Moore, RN
317-274-7477

Locations:

Indiana University Hospital
Indianapolis Indiana 46202 United States

Indiana University Melvin and Bren Simon Cancer Center
Indianapolis Indiana 46202 United States

View trial on ClinicalTrials.gov