Sipuleucel-T and Low-protein Diet in Patients With Metastatic Castrate-resistant Prostate Cancer

NCT03329742 | Completed DMC

• 2 other identifiers: IUSCC-06141706081520
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Prostate Cancer Recurrent

Outcome Measures

Primary Outcomes (1)

• Adherence to diet intervention

  BUN and UUN laboratory values

  6 weeks

Secondary Outcomes (7)

• Feasibility of diet intervention

  6 weeks

• Feasibility of diet intervention

  6 weeks

• Feasibility of diet intervention

  6 weeks

• Safety and tolerability of diet intervention combined with sipuleucel-T treatment

  6 weeks

• Rate of immune response

  6, 12, and 14 weeks

Study Arms (2)

Control protein diet arm

PLACEBO COMPARATOR

20% protein content

Other: Control protein diet

Low protein diet arm

EXPERIMENTAL

10% protein content

Other: Low protein diet

Interventions

Low protein diet OTHER

Patients on this arm will receive a prescribed diet (including all food and recommendations for beverages) that contains 10% protein to begin eating 1 week prior to treatment with sipuleucel-T and throughout treatment (i.e. diet will last approximately 49 days).

Low protein diet arm

Control protein diet OTHER

Patients on this arm will receive a prescribed diet (including all food and recommendations for beverages) that contains 20% protein to begin eating 1 week prior to treatment with sipuleucel-T and throughout treatment (i.e. diet will last approximately 49 days).

Control protein diet arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is for men with asymptomatic or minimally symptomatic, metastatic, androgen independent prostate cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Indiana University School of Medicine: collaborator

Study Sites (2)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Interventions

Diet, Protein-Restricted

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Nabil Adra, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a longitudinal randomized parallel groups design of n=30 subjects randomized in a 1:1 ratio to either sipuleucel-T plus control diet arm (20% protein content) or sipuleucel-T plus intervention low-protein content diet (10% protein diet).

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: November 6, 2017
• Study Start: December 19, 2017
• Primary Completion: October 21, 2019
• Study Completion: May 5, 2020
• Last Updated: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)