Prostate CancerPhase 2NCT02793219
Provenge Followed by Docetaxel in Castration-Resistant Prostate Cancer
A Phase 2 study testing Sipuleucel-T and Docetaxel in people with Prostate Cancer, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This clinical study will evaluate the role of combination therapy of Provenge followed by docetaxel for patients with metastatic castration-resistant prostate cancer (CRPC, (prostate cancer that is resistant to medical or surgical treatments that lower testosterone). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Sipuleucel-T and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Jul 2021
- Phase
- Phase 2
- 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
- Male 18 years and older.
- Pathologic confirmation of prostate adenocarcinoma.
- Asymptomatic or minimally symptomatic disease.
- Presence of skeletal or visceral/nodal metastasis confirmed by MRI, scintigraphy, or CT scan
- Disease progression as indicated by:
- PSA increase indicated by two consecutive higher values over baseline at assessments performed at least 7 days apart from each other in the previous 28 days with the absolute value ≥5 ng/ml; OR
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- Progression of measurable lymph nodes (≥15 mm) measureable per RECIST v1.1 criteria; OR
- New bone lesions appearing on imaging compared with a prior bone scan. (Bone scan to be performed at screening or within the previous 28 days.)
- Maintenance of castrate conditions: Patients who have not had a surgical orchiectomy must continue with hormone therapy (GnRH/LHRH agonists or antagonists) to maintain levels of serum testosterone of <50 ng/dl.
- Patient is clinically immunocompetent. Clinical immunocompetence will be assumed unless a subject has been diagnosed as being immunosuppressed, is receiving oral steroids (nasal sprays and inhalers are permitted), or is receiving immunosuppressive therapy following transplant, in which case they will be excluded.
- Peripheral neuropathy grade ≤1.
- Laboratory criteria:
- Adequate bone marrow function:
- White blood cells ≥4000/mm3
- Absolute neutrophil count ≥1500/mm3
- Absolute lymphocyte count ≥500/µl
- Hemoglobin ≥10 g/dl
- Platelet count ≥100,000/mm3
- Total bilirubin within normal limits (benign hereditary hyperbilirubinemias, e.g., Gilbert's syndrome, are permitted)
- Renal function creatinine ≤1.5 x ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be within normal range.
- Life expectancy of at least 6 months based on Investigators' judgment
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- At least 4 weeks after surgery or radiotherapy
- If patients have been receiving bisphosphonate or denosumab, they can continue either medication.
- Sufficient washout period from previous anti-androgen and hormonal therapies (PSA regression verification required after casodex withdrawal during the 6-week washout period).
- Patient is willing and available to attend clinic visits at least every 2 weeks.
- Signed, informed consent, including patient's ability to comprehend its contents
Who cannot join
- Patient's disease burden is greater than the prognostic criteria defined earlier, including the presence of visceral or bone metastases.
- Patient has "currently active" second malignancy, other than non-melanoma skin cancer. Patients are not considered to have a "currently active" malignancy if they have completed therapy >5 years previously and have no known evidence of residual or recurrent disease.
- Current symptomatic cord compression requiring surgery or radiation therapy
- Prior chemotherapy for prostate cancer
- Patient is using supplements or complementary medicines/botanicals. Patients should review the label with their doctor prior to enrolment. The following exceptions are permitted at screening and during the course of the study.
- Conventional multivitamin supplements
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- Selenium
- Lycopene
- Soy supplements
- Vitamin E
- Fish oil supplements
- Vitamin D
- Glucosamine supplements
- Age-related eye disease vitamins
- Ginkgo biloba
- Patient co-morbidities:
- HIV positive
- Acute hepatitis B (HBV) or active hepatitis C (HCV)
- Clinical and laboratory evidence of active bacterial, viral, or fungal infection requiring systemic treatment
- Clinically significant cardiovascular disease including
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Serious cardiac arrhythmia requiring medication
- Uncontrolled hypertension >150/100mm Hg (if controlled with medication this is not an exclusion).
- Hypotension
- Myocardial infarct or ventricular arrhythmia or stroke within a 6-month period prior to inclusion, ejection fraction (EF) <40%, or serious cardiac conduction system disorders
- Patient is exhibiting evidence of symptomatic congestive heart failure, pulmonary embolus, vascular thrombosis, transient ischemic attack, cerebrovascular accident, unstable angina, myocardial infarction or active ischemia if a pacemaker is not present on electrocardiogram (ECG). An ECG must be performed at screening unless the subject has measurable disease in which case an ECG taken prior to screening but within 28 days of start of treatment will be accepted.
- Pleural and pericardial effusion of any CTCAE grade
- Rheumatoid disease (asymptomatic subjects with controlled and rarely flaring rheumatoid arthritis are also excluded)
- Peripheral neuropathy having a CTCAE grade ≥2
- History of malignant disease (with the exception of non-melanoma skin tumors) in the preceding 5 years
- Active autoimmune disease requiring treatment (except non-insulin-dependent diabetes mellitus)
- History of severe forms of primary immune deficiencies
- History of anaphylaxis or other serious reactions following vaccination
- Uncontrolled co-morbidities including psychiatric or social conditions which, in the Investigator's opinion, would prevent participation in the trial
- Patient has had major surgery or radiation therapy completed < 4 weeks prior to screening.
- Patient has had prior exposure to the radiopharmaceuticals radium 223, strontium, or samarium within 8 weeks prior to screening.
- Patient is receiving concurrent chemotherapy, immunotherapy, radiotherapy, or investigational agents.
- Patient has cerebral metastases (known from previous investigations or clinically detectable).
- Patient has serum testosterone >50 ng/dl.
- Systemic corticosteroids at doses >40 mg hydrocortisone daily or equivalent for any reason other than (a) prescribed as replacement therapy in the case of adrenal insufficiency or (b) oral dexamethasone administration used in combination with docetaxel.
- Patient has in the opinion of the physician a serious or uncontrolled intercurrent infection or non-malignant medical illness which is uncontrolled.
- Systemic immunosuppressive therapy for any reason.
- Treatment with anti-androgens, inhibitors of adrenal-produced androgens (abiraterone), androgen receptor inhibitors (enzalutamide), or other hormonal tumor-focused treatment performed on the day of screening or within the previous 4 weeks, including any dose of megestrol acetate, finasteride, any herbal product known to decrease PSA levels (e.g., saw palmetto and PC-SPES), or any systemic corticosteroid must discontinue the agent for at least 4 weeks prior to screening. Progressive disease (as defined above) must be documented after discontinuation of the therapy.
- Refusal to sign the informed consent.
- Participation in a clinical trial using experimental therapy within the last 60 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
UTHealth Memorial Hermann Cancer Center
Houston, Texas, 77030
About this study
This clinical study will evaluate the role of combination therapy of Provenge followed by docetaxel for patients with metastatic castration-resistant prostate cancer (CRPC, (prostate cancer that is resistant to medical or surgical treatments that lower testosterone). The purpose of this study is to look at the combination therapy of Provenge followed by docetaxel to correlate the immunological biomarkers with clinical results for therapy. Biomarkers are genes, proteins and other molecules that affect how cancer cells grow, multiply, die and respond to other compounds in the body. The study drugs are approved by the Food and Drug Administration (FDA).
Treatment will be administered on an outpatient basis. Patients will receive Provenge followed by 6 cycles of docetaxel. Provenge is an immunotherapy (vaccine made from patient's own blood cells) that reprograms immune cells to attack cancer. A course of therapy consists of three doses of Provenge administered at 2-week intervals. Docetaxel is an antineoplastic (chemotherapy that affects cancer cell growth) agent. Docetaxel dose of 75 mg/m2 will be given intravenously as a 1-hour infusion every 21 days on Day 1 for 6 cycles (21 days).
The strategy aims to determine whether cytokine production and T cell infiltration of tumor cells could favor regression using a combination of vaccine plus chemotherapy. Tissue endpoints will include biopsies prior to vaccine therapy and chemotherapy and at the end of therapy. Prostate cancer tissue infiltrates will be studied for expression of CD3, CD4, CD8, CD25/FOX3P, CD56, CTLA-4, PD-1, and Ki67. Additional immunological endpoints will be secondary antigen spread and various cytokine biomarkers.
Read the detailed description
Castration-resistant prostate cancer (CRPC) develops serial treatment resistance and is considered incurable. It is a largely indolent disease, which would give the body time to mount an effective immune response. CRPC is therefore potentially well suited for vaccine therapy.
Sipuleucel-T (Provenge), is an FDA-approved cancer vaccine therapy manufactured by culturing an individual's own freshly isolated peripheral blood mononuclear cells (PBMCs), including antigen-presenting cells (APCs) and T cells, with a fusion protein (PA-2024) composed of prostatic acid phosphatase (PAP) linked to granulocyte macrophage-colony stimulating factor (GM-CSF). A course of therapy consists of three doses of Provenge administered at 2-week intervals.
Docetaxel is an antineoplastic agent belonging to the taxoid family. The FDA-approved course of therapy for prostate cancer consists of 75 mg/m2 docetaxel given intravenously as a 1-hour infusion every 21 days on Day 1.
This is an open-label phase II study in taxane-naïve patients with metastatic CRPC of Provenge followed by docetaxel. Adult (age >18 years) men with pathologically-confirmed adenocarcinoma of the prostate with clinical or radiologic evidence of metastatic disease that has progressed despite treatment with anti-androgens, inhibitors of adrenal-produced androgens (abiraterone), or androgen receptor inhibitors (enzalutamide), and who, prior to study entry are candidates to receive Standard of Care chemotherapy (e.g., docetaxel/prednisone) or immunotherapy (Provenge), will be enrolled in this study.
This study will recruit a total of 32 patients with metastatic CRPC. Patients will receive Provenge followed by 6 cycles of docetaxel. Treatment will be administered on an outpatient basis. Patients must meet one of the following prognostic criteria:
- PSA doubling time >6 months
- ≤3 bone lesions (only if they meet PSA doubling time criteria)
- >3 but ≤10 bone lesions (only if they meet PSA doubling time criteria)
- Nodal disease only
The primary objective of this study is to characterize the immunological biomarkers during therapy and correlate the immunological biomarkers with clinical outcome. The strategy aims to determine whether cytokine production and T cell infiltration of tumor cells could favor regression using a combination of vaccine plus chemotherapy. Tissue endpoints will include biopsies prior to vaccine therapy and chemotherapy and at the end of therapy. Prostate cancer tissue infiltrates will be studied for expression of CD3, CD4, CD8, CD25/FOX3P, CD56, CTLA-4, PD-1, and Ki67. Additional immunological endpoints will be secondary antigen spread and various cytokine biomarkers.
- Conditions
- Prostate Cancer
- Being tested
- Sipuleucel-T, Docetaxel
- Keywords
- Advanced Prostate Cancer, Castration-Resistant Prostate Cancer, CRPC, Adenocarcinoma of the prostate, Metastatic disease
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sipuleucel-TBiological
Also called Provenge
DocetaxelDrug
Also called Taxotere, Docefrez
| Study group | Role | What they receive |
|---|---|---|
| Sipuleucel-T then Docetaxel | Experimental | Sipuleucel-T IV over 1-hour every 14 days for 3 doses; 28 day rest; 75 mg/m2 docetaxel IV over 1-hour every 21 days for 6 cycles Receives: Biological: Sipuleucel-T; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine Activity
measured by staining assays
Measured: 18 months
T-cell Proliferation
measured by flow cytometry
Measured: 18 months
Levels of Serum
measured by staining assays
Measured: 18 months
Tissue Infiltration
measured by staining assays
Measured: 18 months
Secondary Antigen Spread
measured by flow cytometry
Measured: 18 months
Secondary outcomes (6)
Radiographic progression-free survival
Measured: 18 months
PSA response rate
Measured: 18 months
Time to PSA progression
Measured: 18 months
Measure CTCs and characterize response
Measured: 18 months
Objective tumor response rate
Measured: 18 months
Adverse Events
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startDec 2016 (estimated)
- Primary completionJul 2018 (estimated)
- Study completionJul 2021 (estimated)
Why it stopped: Dendreon was sold and new company decided not to fund study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert J Amato, The University of Texas Health Science Center, Houston
- Investigators
- Robert J Amato, DO, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793219
- Sponsor's protocol ID
- GU-15-103
- Other IDs
- HSC-MS-15-0882
- Status last verified
- Oct 2017
- First submitted
- 19 May 2016
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Provenge Followed by Docetaxel in Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT02793219
- Acronym / sponsor ID
- GU-15-103
- Conditions
- Prostate Cancer
- Keywords
- Advanced Prostate Cancer, Castration-Resistant Prostate Cancer, CRPC, Adenocarcinoma of the prostate, Metastatic disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Dendreon was sold and new company decided not to fund study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Dec 2016 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 8 Jun 2016 (estimated)
- 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 clinical study will evaluate the role of combination therapy of Provenge followed by docetaxel for patients with metastatic castration-resistant prostate cancer (CRPC, (prostate cancer that is resistant to medical or surgical treatments that lower testosterone). The purpose of this study is to look at the combination therapy of Provenge followed by docetaxel to correlate the immunological biomarkers with clinical results for therapy. Biomarkers are genes, proteins and other molecules that affect how cancer cells grow, multiply, die and respond to other compounds in the body. The study drugs are approved by the Food and Drug Administration (FDA).
Treatment will be administered on an outpatient basis. Patients will receive Provenge followed by 6 cycles of docetaxel. Provenge is an immunotherapy (vaccine made from patient's own blood cells) that reprograms immune cells to attack cancer. A course of therapy consists of three doses of Provenge administered at 2-week intervals. Docetaxel is an antineoplastic (chemotherapy that affects cancer cell growth) agent. Docetaxel dose of 75 mg/m2 will be given intravenously as a 1-hour infusion every 21 days on Day 1 for 6 cycles (21 days).
The strategy aims to determine whether cytokine production and T cell infiltration of tumor cells could favor regression using a combination of vaccine plus chemotherapy. Tissue endpoints will include biopsies prior to vaccine therapy and chemotherapy and at the end of therapy. Prostate cancer tissue infiltrates will be studied for expression of CD3, CD4, CD8, CD25/FOX3P, CD56, CTLA-4, PD-1, and Ki67. Additional immunological endpoints will be secondary antigen spread and various cytokine biomarkers.
Detailed description
Castration-resistant prostate cancer (CRPC) develops serial treatment resistance and is considered incurable. It is a largely indolent disease, which would give the body time to mount an effective immune response. CRPC is therefore potentially well suited for vaccine therapy.
Sipuleucel-T (Provenge), is an FDA-approved cancer vaccine therapy manufactured by culturing an individual's own freshly isolated peripheral blood mononuclear cells (PBMCs), including antigen-presenting cells (APCs) and T cells, with a fusion protein (PA-2024) composed of prostatic acid phosphatase (PAP) linked to granulocyte macrophage-colony stimulating factor (GM-CSF). A course of therapy consists of three doses of Provenge administered at 2-week intervals.
Docetaxel is an antineoplastic agent belonging to the taxoid family. The FDA-approved course of therapy for prostate cancer consists of 75 mg/m2 docetaxel given intravenously as a 1-hour infusion every 21 days on Day 1.
This is an open-label phase II study in taxane-naïve patients with metastatic CRPC of Provenge followed by docetaxel. Adult (age >18 years) men with pathologically-confirmed adenocarcinoma of the prostate with clinical or radiologic evidence of metastatic disease that has progressed despite treatment with anti-androgens, inhibitors of adrenal-produced androgens (abiraterone), or androgen receptor inhibitors (enzalutamide), and who, prior to study entry are candidates to receive Standard of Care chemotherapy (e.g., docetaxel/prednisone) or immunotherapy (Provenge), will be enrolled in this study.
This study will recruit a total of 32 patients with metastatic CRPC. Patients will receive Provenge followed by 6 cycles of docetaxel. Treatment will be administered on an outpatient basis. Patients must meet one of the following prognostic criteria:
- PSA doubling time >6 months
- ≤3 bone lesions (only if they meet PSA doubling time criteria)
- >3 but ≤10 bone lesions (only if they meet PSA doubling time criteria)
- Nodal disease only
The primary objective of this study is to characterize the immunological biomarkers during therapy and correlate the immunological biomarkers with clinical outcome. The strategy aims to determine whether cytokine production and T cell infiltration of tumor cells could favor regression using a combination of vaccine plus chemotherapy. Tissue endpoints will include biopsies prior to vaccine therapy and chemotherapy and at the end of therapy. Prostate cancer tissue infiltrates will be studied for expression of CD3, CD4, CD8, CD25/FOX3P, CD56, CTLA-4, PD-1, and Ki67. Additional immunological endpoints will be secondary antigen spread and various cytokine biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sipuleucel-T then Docetaxel | Experimental | Biological: Sipuleucel-T, Drug: DocetaxelSipuleucel-T IV over 1-hour every 14 days for 3 doses; 28 day rest; 75 mg/m2 docetaxel IV over 1-hour every 21 days for 6 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Male 18 years and older.
- Pathologic confirmation of prostate adenocarcinoma.
- Asymptomatic or minimally symptomatic disease.
- Presence of skeletal or visceral/nodal metastasis confirmed by MRI, scintigraphy, or CT scan
- Disease progression as indicated by:
Key exclusion criteria (46 listed)
- Patient's disease burden is greater than the prognostic criteria defined earlier, including the presence of visceral or bone metastases.
- Patient has "currently active" second malignancy, other than non-melanoma skin cancer. Patients are not considered to have a "currently active" malignancy if they have completed therapy >5 years previously and have no known evidence of residual or recurrent disease.
- Current symptomatic cord compression requiring surgery or radiation therapy
- Prior chemotherapy for prostate cancer
- Patient is using supplements or complementary medicines/botanicals. Patients should review the label with their doctor prior to enrolment. The following exceptions are permitted at screening and during the course of the study.
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 |
|---|---|---|
| Sipuleucel-TAlso: Provenge | Biological | Sipuleucel-T then Docetaxel |
| DocetaxelAlso: Taxotere, Docefrez | Drug | Sipuleucel-T then Docetaxel |
Primary outcome
Cytokine Activity
Time frame: 18 months
measured by staining assays
T-cell Proliferation
Time frame: 18 months
measured by flow cytometry
Levels of Serum
Time frame: 18 months
measured by staining assays
Tissue Infiltration
Time frame: 18 months
measured by staining assays
Secondary Antigen Spread
Time frame: 18 months
measured by flow cytometry
6 secondary outcomes
Radiographic progression-free survival
Time frame: 18 months
PSA response rate
Time frame: 18 months
Time to PSA progression
Time frame: 18 months
Measure CTCs and characterize response
Time frame: 18 months
Objective tumor response rate
Time frame: 18 months
Adverse Events
Time frame: 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
- 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.
Robert J Amato, DO principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sipuleucel-T and Docetaxel in people with Prostate Cancer, run by The University of Texas Health Science Center, Houston at 1 site 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 28 inclusion and 46 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: withdrawn, as of the sponsor's last update on 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Cytokine Activity (time frame: 18 months). The study lists 5 primary outcomes in all. 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 30 Oct 2017.