Prostate Cancer RecurrentNCT03329742
Sipuleucel-T and Low-protein Diet in Patients With Metastatic Castrate-resistant Prostate Cancer
A study testing Low protein diet in people with Prostate Cancer Recurrent, run by Indiana University at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Recurrent
- What is being tested?
- Low protein diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Dec 2017to 5 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University Hospital
Indianapolis, Indiana, 46202
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: A Pilot Feasibility Study of Sipuleucel-T vs. Sipuleucel-T and Low-protein Diet in Patients With Metastatic Castrate-resistant Prostate Cancer (CRPC)
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.
Read more
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).
Read the detailed description
Primary Objective To assess the feasibility of low-protein diet intervention in patients with metastatic CRPC receiving immunotherapy with sipuleucel-T. Change in blood urea nitrogen (BUN) and urine urea nitrogen (UUN) from baseline to 6 weeks will be measured to assess adherence of following the diet intervention. The expected changes (mean, standard deviation) in BUN are 5.5 ± 2.6 mg/dL with 10% protein diet arm and 2.5 ± 2.6 mg/dL with 20% protein diet arm (please see section 12.5.7).
Secondary Objectives
- To assess whether low-protein diet intervention augments the immune response to sipuleucel-T in men with metastatic CRPC.
- To assess the safety and tolerability of the combination of sipuleucel-T and low-protein diet intervention.
- To obtain preliminary evidence of clinical efficacy of the combination of sipuleucel-T and low-protein diet compared to sipuleucel-T and control-diet, including objective response rate (partial + complete response), progression-free survival (PFS) and overall survival (OS), and changes in prostate-specific antigen (PSA).
- Conditions
- Prostate Cancer Recurrent
- Being tested
- Low protein diet, Control protein diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low protein dietOther
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).
Control protein dietOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Control protein diet arm | Placebo comparator | 20% protein content Receives: Other: Control protein diet |
| Low protein diet arm | Experimental | 10% protein content Receives: Other: Low protein diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to diet intervention
BUN and UUN laboratory values
Measured: 6 weeks
Secondary outcomes (7)
Feasibility of diet intervention
Patient self-report of compliance
Measured: 6 weeks
Feasibility of diet intervention
Rate of drop-out
Measured: 6 weeks
Feasibility of diet intervention
Rate of enrollment
Measured: 6 weeks
Safety and tolerability of diet intervention combined with sipuleucel-T treatment
Rate of adverse events per CTCAE
Measured: 6 weeks
Rate of immune response
IFN-γ ELISpot specific for PA2024 laboratory values
Measured: 6, 12, and 14 weeks
Progression free survival
Length of time during and after the treatment that a patient lives with the disease but it does not get worse
Measured: 2 years
Overall survival
Length of time start of treatment that patients are still alive
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start19 Dec 2017
- Primary completion21 Oct 2019
- Study completion5 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer RecurrentStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabil Adra, Indiana University
- Investigators
- Nabil Adra, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329742
- Sponsor's protocol ID
- IUSCC-0614
- Other IDs
- 1706081520
- Status last verified
- Mar 2021
- First submitted
- 23 Oct 2017
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study of Sipuleucel-T vs. Sipuleucel-T and Low-protein Diet in Patients With Metastatic Castrate-resistant Prostate Cancer (CRPC)
- ClinicalTrials.gov ID
- NCT03329742
- Acronym / sponsor ID
- IUSCC-0614
- Conditions
- Prostate Cancer Recurrent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 19 Dec 2017 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 5 May 2020 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Primary Objective To assess the feasibility of low-protein diet intervention in patients with metastatic CRPC receiving immunotherapy with sipuleucel-T. Change in blood urea nitrogen (BUN) and urine urea nitrogen (UUN) from baseline to 6 weeks will be measured to assess adherence of following the diet intervention. The expected changes (mean, standard deviation) in BUN are 5.5 ± 2.6 mg/dL with 10% protein diet arm and 2.5 ± 2.6 mg/dL with 20% protein diet arm (please see section 12.5.7).
Secondary Objectives
- To assess whether low-protein diet intervention augments the immune response to sipuleucel-T in men with metastatic CRPC.
- To assess the safety and tolerability of the combination of sipuleucel-T and low-protein diet intervention.
- To obtain preliminary evidence of clinical efficacy of the combination of sipuleucel-T and low-protein diet compared to sipuleucel-T and control-diet, including objective response rate (partial + complete response), progression-free survival (PFS) and overall survival (OS), and changes in prostate-specific antigen (PSA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Control protein diet arm | Placebo comparator | Other: Control protein diet20% protein content |
| Low protein diet arm | Experimental | Other: Low protein diet10% protein content |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
- Life expectancy of at least 6 months
- Men ≥ 18 years of age
Key exclusion criteria (20 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low protein dietPatients 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). | Other | Low protein diet arm |
| Control protein dietPatients 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). | Other | Control protein diet arm |
Primary outcome
Adherence to diet intervention
Time frame: 6 weeks
BUN and UUN laboratory values
7 secondary outcomes
Feasibility of diet intervention
Time frame: 6 weeks
Feasibility of diet intervention
Time frame: 6 weeks
Feasibility of diet intervention
Time frame: 6 weeks
Safety and tolerability of diet intervention combined with sipuleucel-T treatment
Time frame: 6 weeks
Rate of immune response
Time frame: 6, 12, and 14 weeks
Progression free survival
Time frame: 2 years
Overall survival
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nabil Adra, MD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low protein diet in people with Prostate Cancer Recurrent, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to diet intervention (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.