Prostate CancerPhase 1NCT02036918
Dendreon Lymph Node Biopsy in Metastatic Castrate-Resistant Prostate Cancer
A Phase 1 study testing Sipuleucel-T and Lymph Node Biopsy in people with Prostate Cancer, run by Duke University at 1 site in United States.
Trial summary
This study aims to evaluate patients with metastatic castrate-resistant prostate cancer (mCRPC) undergoing treatment with sipuleucel-T for evidence of treatment-associated immune activation in lymph nodes and peripheral blood. 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 Lymph Node Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 6 Feb 2019
- Phase
- Phase 1
- 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
- Age ≥ 18 years
- ECOG performance status 0 or 1
- Life expectancy of ≥ 6 months
- Minimally-symptomatic or asymptomatic, castrate-resistant metastatic prostate cancer, as evidenced by all of the following:
- Histologically-confirmed diagnosis of adenocarcinoma of the prostate
- Evidence of adequate androgen deprivation, as evidence by one of the following:
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- Bilateral orchiectomy
- Ongoing LHRH agonist (e.g. leuprolide, goserelin) and serum testosterone <50 ng/dl
- Ongoing LHRH antagonist (e.g. degarelix) and serum testosterone <50 ng/dl
- Evidence of prostate cancer resistance to castration, as evidenced by one of the following:
- 2 consecutive PSA levels that are ≥ 50% above the PSA nadir achieved on ADT and obtained at least 1 week apart
- CT or MRI based evidence of disease progression (soft tissue or nodal) according to PCWG2 criteria or RECIST 1.1 criteria, or at least 1 new bone scan lesion as compared to the most immediate prior radiologic studies.
- Presence of non-visceral metastases on imaging
- Absence of major symptoms directly attributable to prostate cancer, with the following permissible exceptions:
- Ureteral obstruction secondary to pelvic or retroperitoneal lymphadenopathy
- Bladder outlet obstruction secondary to locally recurrent prostate cancer
- Radiographic evidence of lymphadenopathy, defined as a lymph node greater than 1 cm in diameter on axial imaging (CT or MRI or PET/CT)
- Adequate laboratory parameters
- A minimum of 4 weeks from any major surgery prior to registration. Coincident standard of care surgery with the research biopsy is permitted during the study.
Who cannot join
- Prior treatment with sipuleucel-T
- Allergy to any component of sipuleucel-T
- Inability to undergo leukapheresis
- History of neuroendocrine variants of prostate cancer, including small cell carcinoma of the prostate
- Extensive prior surgery/radiation present that would render the biopsy highly complex and the risk of intraoperative injury high
- Any chronic medical condition requiring daily corticosteroids or other immunosuppressants
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- Solid organ transplantation requiring immunosuppression
- Visceral (e.g. lung, liver) metastases
- Known brain metastases
- History of spinal cord compression
- Untreated/unstabilized pathologic long bone fractures
- Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months
- Administration of any investigational therapeutic within 30 days of registration
- Any condition which, in the opinion of the investigator, would preclude participation in this trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Evaluation of Lymph Node Metastases in Men Undergoing Treatment With Sipuleucel-T for Metastatic Castrate-resistant Prostate Cancer
This study aims to evaluate patients with metastatic castrate-resistant prostate cancer (mCRPC) undergoing treatment with sipuleucel-T for evidence of treatment-associated immune activation in lymph nodes and peripheral blood.
Read the detailed description
This is a pilot study of mCRPC patients planning to undergo therapy with sipuleucel-T immunotherapy. Consenting patients will be randomized 3:1 between immediate sipuleucel-T immunotherapy followed by lymph node biopsy (the post-treatment experimental group) or immediate lymph node biopsy followed by sipuleucel-T immunotherapy (the pre-treatment control group). Peripheral blood will be collected before, during, and after treatment with sipuleucel-T and evaluated for evidence of sipuleucel-T induced immune activation. Lymph nodes collected at biopsy will also be evaluated for evidence of sipuleucel-T induced immune activation. Patients will be followed for 3 months for safety and 6 months for disease progression.
- Conditions
- Prostate Cancer
- Being tested
- Sipuleucel-T, Lymph Node Biopsy
- Keywords
- castrate resistant prostate cancer, metastatic, sipuleucel-T, lymphadenectomy, Excisional lymph node biopsy
- 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-TDrug
Also called Provenge
Lymph Node BiopsyProcedure or surgery
Also called lymphadenectomy, lymph node dissection, excisional lymph node biopsy
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Pre-treatment control group will be randomized to immediate lymph node biopsy followed by sipuleucel-T immunotherapy. Receives: Drug: Sipuleucel-T; Procedure: Lymph Node Biopsy |
| Arm B | Experimental | Post-treatment experimental group will be randomized to immediate sipuleucel-T immunotherapy followed by lymph node biopsy. Receives: Drug: Sipuleucel-T; Procedure: Lymph Node Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
anti-PA2024 immune response in lymph node-derived leukocytes
Proportion of patients with lymph node-derived leukocytes showing anti-PA2024 activity as measured by IFNγ ELISPOT
Measured: Lymph node biopsy, approximately 10 weeks
anti-PAP immune response in lymph node-derived leukocytes
Proportion of patients with lymph node-derived leukocytes showing anti-PAP activity as measured by IFNγ ELISPOT
Measured: Lymph node biopsy, approximately 10 weeks
anti-PA2024 immune response in PBMCs
Proportion of patients with PBMC samples showing anti-PA2024 activity as measured by IFNγ ELISPOT at each time point
Measured: Baseline
anti-PAP immune response in PBMCs
Proportion of patients with PBMC samples showing anti-PAP activity as measured by IFNγ ELISPOT at each time point
Measured: Baseline
anti-PA2024 immune response in PBMCs
Proportion of patients with PBMC samples showing anti-PA2024 activity as measured by IFNγ ELISPOT at each time point
Measured: Prior to sipuleucel-T infusion 2, approximately 6 weeks
anti-PAP immune response in PBMCs
Proportion of patients with PBMC samples showing anti-PAP activity as measured by IFNγ ELISPOT at each time point
Measured: Prior to sipuleucel-T infusion 2, approximately 6 weeks
anti-PA2024 immune response in PBMCs
Proportion of patients with PBMC samples showing anti-PA2024 activity as measured by IFNγ ELISPOT at each time point
Measured: Prior to sipuleucel-T infusion 3, approximately 8 weeks
anti-PAP immune response in PBMCs
Proportion of patients with PBMC samples showing anti-PAP activity as measured by IFNγ ELISPOT at each time point
Measured: Prior to sipuleucel-T infusion 3, approximately 8 weeks
anti-PA2024 immune response in PBMCs
Proportion of patients with PBMC samples showing anti-PA2024 activity as measured by IFNγ ELISPOT at each time point
Measured: 2 weeks after the last sipuleucel-T infusion
anti-PAP immune response in PBMCs
Proportion of patients with PBMC samples showing anti-PAP activity as measured by IFNγ ELISPOT at each time point
Measured: 2 weeks after the last sipuleucel-T infusion
anti-PA2024 immune response in PBMCs
Proportion of patients with PBMC samples showing anti-PA2024 activity as measured by IFNγ ELISPOT at each time point
Measured: 3 months post-treatment
anti-PAP immune response in PBMCs
Proportion of patients with PBMC samples showing anti-PAP activity as measured by IFNγ ELISPOT at each time point
Measured: 3 months post-treatment
anti-PA2024 immune response in PBMCs
Proportion of patients with PBMC samples showing anti-PA2024 activity as measured by IFNγ ELISPOT at each time point
Measured: 6 months post-treatment
anti-PAP immune response in PBMCs
Proportion of patients with PBMC samples showing anti-PAP activity as measured by IFNγ ELISPOT at each time point
Measured: 6 months post-treatment
Secondary outcomes (2)
Serum anti-PA2024 antibody level
Describe any relationship between the magnitude of sipuleucel-T induced leukocyte activation observed in tumor-bearing lymph nodes with systemic (i.e. peripheral blood) studies of sipuleucel-T-induced immune activation
Measured: Baseline, up to 6 months post-treatment
serum anti-PAP antibody level
Describe any relationship between the magnitude of sipuleucel-T induced leukocyte activation observed in tumor-bearing lymph nodes with systemic (i.e. peripheral blood) studies of sipuleucel-T-induced immune activation
Measured: Baseline, up to 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startMar 2014
- Primary completion6 Feb 2019
- Study completion6 Feb 2019
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 Duke 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brant Inman, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036918
- Sponsor's protocol ID
- Pro00047231
- Status last verified
- Mar 2020
- First submitted
- 13 Jan 2014
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lymph Node Metastases in Men Undergoing Treatment With Sipuleucel-T for Metastatic Castrate-resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT02036918
- Acronym / sponsor ID
- Pro00047231
- Conditions
- Prostate Cancer
- Keywords
- castrate resistant prostate cancer, metastatic, sipuleucel-T, lymphadenectomy, Excisional lymph node biopsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- 6 Feb 2019 (actual)
- Study completion
- 6 Feb 2019 (actual)
- First posted
- 15 Jan 2014 (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 study aims to evaluate patients with metastatic castrate-resistant prostate cancer (mCRPC) undergoing treatment with sipuleucel-T for evidence of treatment-associated immune activation in lymph nodes and peripheral blood.
Detailed description
This is a pilot study of mCRPC patients planning to undergo therapy with sipuleucel-T immunotherapy. Consenting patients will be randomized 3:1 between immediate sipuleucel-T immunotherapy followed by lymph node biopsy (the post-treatment experimental group) or immediate lymph node biopsy followed by sipuleucel-T immunotherapy (the pre-treatment control group). Peripheral blood will be collected before, during, and after treatment with sipuleucel-T and evaluated for evidence of sipuleucel-T induced immune activation. Lymph nodes collected at biopsy will also be evaluated for evidence of sipuleucel-T induced immune activation. Patients will be followed for 3 months for safety and 6 months for disease progression.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Sipuleucel-T, Procedure: Lymph Node BiopsyPre-treatment control group will be randomized to immediate lymph node biopsy followed by sipuleucel-T immunotherapy. |
| Arm B | Experimental | Drug: Sipuleucel-T, Procedure: Lymph Node BiopsyPost-treatment experimental group will be randomized to immediate sipuleucel-T immunotherapy followed by lymph node biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age ≥ 18 years
- ECOG performance status 0 or 1
- Life expectancy of ≥ 6 months
- Minimally-symptomatic or asymptomatic, castrate-resistant metastatic prostate cancer, as evidenced by all of the following:
- Radiographic evidence of lymphadenopathy, defined as a lymph node greater than 1 cm in diameter on axial imaging (CT or MRI or PET/CT)
Key exclusion criteria (14 listed)
- Prior treatment with sipuleucel-T
- Allergy to any component of sipuleucel-T
- Inability to undergo leukapheresis
- History of neuroendocrine variants of prostate cancer, including small cell carcinoma of the prostate
- Extensive prior surgery/radiation present that would render the biopsy highly complex and the risk of intraoperative injury high
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 | Drug | Arm A, Arm B |
| Lymph Node BiopsyAlso: lymphadenectomy, lymph node dissection, excisional lymph node biopsy | Procedure or surgery | Arm A, Arm B |
Primary outcome
anti-PA2024 immune response in lymph node-derived leukocytes
Time frame: Lymph node biopsy, approximately 10 weeks
Proportion of patients with lymph node-derived leukocytes showing anti-PA2024 activity as measured by IFNγ ELISPOT
anti-PAP immune response in lymph node-derived leukocytes
Time frame: Lymph node biopsy, approximately 10 weeks
Proportion of patients with lymph node-derived leukocytes showing anti-PAP activity as measured by IFNγ ELISPOT
anti-PA2024 immune response in PBMCs
Time frame: Baseline
Proportion of patients with PBMC samples showing anti-PA2024 activity as measured by IFNγ ELISPOT at each time point
anti-PAP immune response in PBMCs
Time frame: Baseline
Proportion of patients with PBMC samples showing anti-PAP activity as measured by IFNγ ELISPOT at each time point
anti-PA2024 immune response in PBMCs
Time frame: Prior to sipuleucel-T infusion 2, approximately 6 weeks
Proportion of patients with PBMC samples showing anti-PA2024 activity as measured by IFNγ ELISPOT at each time point
anti-PAP immune response in PBMCs
Time frame: Prior to sipuleucel-T infusion 2, approximately 6 weeks
Proportion of patients with PBMC samples showing anti-PAP activity as measured by IFNγ ELISPOT at each time point
anti-PA2024 immune response in PBMCs
Time frame: Prior to sipuleucel-T infusion 3, approximately 8 weeks
Proportion of patients with PBMC samples showing anti-PA2024 activity as measured by IFNγ ELISPOT at each time point
anti-PAP immune response in PBMCs
Time frame: Prior to sipuleucel-T infusion 3, approximately 8 weeks
Proportion of patients with PBMC samples showing anti-PAP activity as measured by IFNγ ELISPOT at each time point
anti-PA2024 immune response in PBMCs
Time frame: 2 weeks after the last sipuleucel-T infusion
Proportion of patients with PBMC samples showing anti-PA2024 activity as measured by IFNγ ELISPOT at each time point
anti-PAP immune response in PBMCs
Time frame: 2 weeks after the last sipuleucel-T infusion
Proportion of patients with PBMC samples showing anti-PAP activity as measured by IFNγ ELISPOT at each time point
anti-PA2024 immune response in PBMCs
Time frame: 3 months post-treatment
Proportion of patients with PBMC samples showing anti-PA2024 activity as measured by IFNγ ELISPOT at each time point
anti-PAP immune response in PBMCs
Time frame: 3 months post-treatment
Proportion of patients with PBMC samples showing anti-PAP activity as measured by IFNγ ELISPOT at each time point
anti-PA2024 immune response in PBMCs
Time frame: 6 months post-treatment
Proportion of patients with PBMC samples showing anti-PA2024 activity as measured by IFNγ ELISPOT at each time point
anti-PAP immune response in PBMCs
Time frame: 6 months post-treatment
Proportion of patients with PBMC samples showing anti-PAP activity as measured by IFNγ ELISPOT at each time point
2 secondary outcomes
Serum anti-PA2024 antibody level
Time frame: Baseline, up to 6 months post-treatment
serum anti-PAP antibody level
Time frame: Baseline, up to 6 months post-treatment
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 31 Mar 2020.
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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.
Brant Inman, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sipuleucel-T and Lymph Node Biopsy in people with Prostate Cancer, run by Duke University 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 19 inclusion and 14 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 31 Mar 2020. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
anti-PA2024 immune response in lymph node-derived leukocytes (time frame: Lymph node biopsy, approximately 10 weeks). The study lists 14 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 31 Mar 2020.