Prostatic NeoplasmsPhase 2NCT02362451
Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Men With Stage D0 Prostate Cancer
A Phase 2 study testing Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccine in people with Prostatic Neoplasms and Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Men who continue to have an elevated or rising prostate specific antigen (PSA) level after their primary prostate cancer treatment are at increased risk for their cancer to progress. The time it takes to progress is highly variable. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms, Prostate Cancer
- What is being tested?
- Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2015to 13 Feb 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
None listed.
Who cannot join
- Patients with an active second malignancy other than adequately treated squamous or basal cell carcinoma of the skin.
- Patients with active infection.
- Patients on immunosuppressive therapy including:
- Systemic corticosteroid therapy for any reason. Patients receiving inhaled or topical corticosteroids may participate.
- Other significant or uncontrolled medical illness. Patients with a remote history of asthma or active mild asthma may participate.
- Patients who, in the opinion of the Principal Investigator, have significant medical or psychosocial problems that warrant exclusion
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Randomized, Placebo-Controlled Phase II Study of Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Men With Stage D0 Prostate Cancer
Background:
- Men who continue to have an elevated or rising prostate specific antigen (PSA) level after their primary prostate cancer treatment are at increased risk for their cancer to progress. The time it takes to progress is highly variable. One way to predict this progression is based on the change in PSA levels over time. This is called the PSA doubling time (PSADT). Researchers want to test a vaccine on men with Stage D0 prostate cancer. Stage D0 means the PSA has become detectable again or has started to rise after primary treatment, but has not spread to other organs.
Read more
Objectives:
- To test a vaccines effectiveness on the rate of PSA increase using PSADT and tumor growth rates.
Eligibility:
- Men with Stage D0 prostate cancer with a PSADT between 3 and 15 months.
Design:
- Participants will be screened with blood tests, scans, physical exam, and medical history. Their prostate cancer will be confirmed.
- Participants will undergo apheresis. Blood will be removed with a needle from one arm. A machine will separate the white blood cells. The blood, minus the white cells, will be returned through a needle in the other arm.
- Participants will have 14 visits. At each visit, they will have a physical exam and blood tests. They will discuss any side effects.
- Participants will get injections of either the vaccine or placebo at weeks 3, 6, 9, 12, 15, and 24. Both will be made from the participants own cells.
- Participants will be selected randomly to receive either active vaccine or placebo. For every two participants assigned to active vaccine, one participant will be assigned to placebo vaccine.
- Participants will get a Vaccine Report Card to to complete after receiving vaccine.
- The study lasts 96 weeks.
Read the detailed description
TARP
- T-cell receptor g alternate reading frame protein (TARP) is a 58 amino acid protein expressed by both normal and malignant prostate cancer tissue; 95% of prostate cancer specimens are positive for TARP expression. TARP is highly expressed in prostate cancers of all Gleason types, in primary as well as metastatic disease, and in hormone sensitive and castrate resistant prostate cancer. Therefore, TARP is an ideal tumor antigen target for a vaccine.
- A prospective, randomized pilot study of 1st generation TARP Peptide vaccination (National Cancer Institute (NCI) 09-C-0139) utilizing TARP WT 27-35 and EE29-37-9V peptides was conducted in human leukocyte antigen serotype within the HLA-A serotype group (HLA-A 0201) positive men with stage D0 prostate cancer (prostate specific antigen (PSA) biochemical recurrence) and a PSA doubling time (PSADT) of greater than or equal to 3 months and less than or equal to 15 months. TARP vaccination was found to be immunogenic, safe and well tolerated, with adverse events limited to injection site reactions less than or equal to Grade 2. TARP vaccination was also associated with a decreased slope log PSA compared to pre-vaccination baseline in 72% of subjects reaching 24 weeks and 74% reaching 48 weeks (p=0.0012 and p=0.0004 for overall changes in slope log PSA, respectively); TARP vaccination also resulted in a 50% decrease in calculated tumor growth rate constant: pre-vaccine g = 0.0042/day, post-vaccine g = 0.0021/day (p=0.003); TARP-specific interferon gamma (IFN-g) enzyme-linked immune absorbent spot (ELISPOT) responses were detected in the majority of subjects but did not correlate with decreases in slope log (PSA).
Multi-Epitope (ME) TARP Vaccine
- The vaccine platform includes the original two 9-mer HLA-A*0201 binding TARP peptide epitopes (WT27-35 and EE29-37-9V) utilized in NCI 09-C-0139 as well as an additional five 20-mer TARP peptides overlapping by 10 amino acids for a total of 7 peptides that span the amino acid sequence of the entire TARP protein.
- The advantage of this multi-epitope TARP peptide vaccine platform is that the overlapping epitopes cover the entire TARP protein, resulting in potential for induction of a multi-valent anti-TARP response. In addition, these longer synthetic peptides include TARP-specific major histocompatibility complex (MHC)class II cluster of differentiation 4 (CD4)+ T cell helper epitopes that will allow generation of better cluster of differentiation 8 (CD8)+ T cell responses with improved functional avidity and longevity as well as humoral anti-TARP antibody responses.
Study Objectives:
Primary:
-To assess the difference in the slope log (PSA) for Weeks3-24 minus that formed for the 12 months prior to enrollment on study (referred to as slope324 pre-slope) as well as the slope log (PSA) for weeks 3-48 versus the same pre-treatment slope log (PSA) (referred to as slope 348 preslope) in patients na(SqrRoot) ve to TARP vaccination receiving active, multi-epitope TARP vaccination vs. placebo.
Eligibility:
- Males greater than or equal to 18 years of age with histologically confirmed adenocarcinoma of the prostate.
- Stage D0 disease with documented biochemical progression documented by rising PSA and no evidence of metastatic disease by physical examination, computed tomography (CT) scan or bone scan.
- Prostate specific antigen doubling time (PSADT) greater than or equal to 3 months and less than or equal to 15 months: ----Patients must have greater than or equal to 3 PSA measurements over greater than or equal to 3 months. --- The interval between PSA measurements must be greater than or equal to 4 weeks.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) 0-1.
- No other concurrent anticancer therapy or prior prostate cancer vaccines expressing TARP.
Study Design:
- Phase II, prospective, single-blinded, randomized, placebo controlled study of 96 weeks duration in men with Stage D0 prostate cancer. Men with a PSADT greater than or equal to 3 months and less than or equal to 15 months will be randomized 2:1 to receive multi-epitope (ME) TARP autologous dendritic cell (DC) vaccination or a control eleutriated monocyte vaccine placebo.
- An initial lead-in of 6 patientswill be enrolled to allow preliminary assessment of the safety of the ME TARP vaccine platform through 12 weeks before enrollment of prospectively randomized subjects blinded to treatment assignment begins.
- All patients will receive a total of 6 doses of vaccine (20 x10(6) viable cells/dose) delivered intradermally at Weeks 3, 6, 9, 12, 15, and 24. All patients will undergo a 15-18L apheresis at Week 0 and restaging at Weeks 48 and 96 to confirm maintenance of Stage D0 disease.
Sample size: N = 72 (6 lead-in patients for safety assessment, 2:1 randomization: TARP N = 44; placebo N =22).
- Conditions
- Prostatic Neoplasms, Prostate Cancer
- Being tested
- Autologus elutriated monocyte placebo vaccine, Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccine
- Keywords
- Dendritic Cell Vaccine, Multi Epitope Tarp Peptide, Autolougous Dendritic Cell, D0 Prostate Cancer, Vaccine Therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologus elutriated monocyte placebo vaccineBiological
20x10^6 viable cells/dose at weeks 3, 6, 9, 12, 15 and 24
Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccineBiological
20x10^6 viable cells/dose at weeks 3, 6, 9, 12, 15 and 24
| Study group | Role | What they receive |
|---|---|---|
| 1/Lead-in T-cell Receptor g Alternate Reading Frame Protein Dendritic Cell (DC) Vaccine Treatment | Experimental | All patients to receive autologous multi-epitope T-cell receptor g alternate reading frame protein (TARP) DC vaccine before randomization Receives: Biological: Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccine |
| 2/Active T-cell Receptor g Alternate Reading Frame Protein Dendritic Cell (DC) Vaccine Treatment | Experimental | Autologous multi-epitope T-cell receptor g alternate reading frame protein (TARP) DC vaccine after randomization Receives: Biological: Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccine |
| 3/Placebo | Placebo comparator | Autologous elutriated monocyte vaccine placebo after randomization Receives: Biological: Autologus elutriated monocyte placebo vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Slope Log of Prostate-specific Antigen Pre vs Post Treatment
PSA Doubling Time (PSADT) and slope log (PSA) were calculated at every study visit using the PSADT Memorial Sloane Kettering nomogram. The values were calculated to demonstrate the rate of rise of PSA, expressed as the velocity in nanograms/mL/year, or the PSA doubling time, in months or years. PSA is a tumor marker for prostate cancer and after surgery (undetectable - e.g. <0.2 ng/mL) or radiation PSA should fall to a very low level when the disease is effectively treated. When PSA increases (>2.0 ng/mL) after surgery or radiation that could mean recurrence of the disease. If prostate cancer is growing slower or shrinking after the treatment, PSADT can be longer while PSA slope log is shorter as tumor will make less PSA.
Measured: One year pre-enrollment; weeks 3-24, and 3 - 48 post vaccine
Secondary outcomes (1)
Progression Free Survival (PFS)
PFS is defined as the duration of time from start of vaccine treatment to time of progression or death. Given the study population in biochemically recurrent prostate cancer, progression is defined as 1)"radiographic progression" by computed tomography (CT) or bone scan, 2) prostate-specific antigen doubling time (PSADT) that is 3 month or shorter, 3) PSADT decrease 50% or more compared to enrollment PSADT.
Measured: Week 96 after initial vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study start10 Jul 2015
- Primary completion13 Feb 2020
- Study completion13 Feb 2020
Why it stopped: Slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Hoyoung M. Maeng, M.D., National Cancer Institute (NCI)
- Investigators
- Hoyoung M Maeng, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362451
- Sponsor's protocol ID
- 150075
- Other IDs
- 15-C-0075
- Status last verified
- Mar 2022
- First submitted
- 12 Feb 2015
- Last updated
- 18 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request. All collected individual participant data (IPD) will be shared with collaborators under the terms of collaborative agreements.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Phase II Study of Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Men With Stage D0 Prostate Cancer
- ClinicalTrials.gov ID
- NCT02362451
- Acronym / sponsor ID
- 150075
- Conditions
- Prostatic Neoplasms, Prostate Cancer
- Keywords
- Dendritic Cell Vaccine, Multi Epitope Tarp Peptide, Autolougous Dendritic Cell, D0 Prostate Cancer, Vaccine Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 10 Jul 2015 (actual)
- Primary completion
- 13 Feb 2020 (actual)
- Study completion
- 13 Feb 2020 (actual)
- First posted
- 13 Feb 2015 (estimated)
- Results
- Posted 8 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Men who continue to have an elevated or rising prostate specific antigen (PSA) level after their primary prostate cancer treatment are at increased risk for their cancer to progress. The time it takes to progress is highly variable. One way to predict this progression is based on the change in PSA levels over time. This is called the PSA doubling time (PSADT). Researchers want to test a vaccine on men with Stage D0 prostate cancer. Stage D0 means the PSA has become detectable again or has started to rise after primary treatment, but has not spread to other organs.
Objectives:
- To test a vaccines effectiveness on the rate of PSA increase using PSADT and tumor growth rates.
Eligibility:
- Men with Stage D0 prostate cancer with a PSADT between 3 and 15 months.
Design:
- Participants will be screened with blood tests, scans, physical exam, and medical history. Their prostate cancer will be confirmed.
- Participants will undergo apheresis. Blood will be removed with a needle from one arm. A machine will separate the white blood cells. The blood, minus the white cells, will be returned through a needle in the other arm.
- Participants will have 14 visits. At each visit, they will have a physical exam and blood tests. They will discuss any side effects.
- Participants will get injections of either the vaccine or placebo at weeks 3, 6, 9, 12, 15, and 24. Both will be made from the participants own cells.
- Participants will be selected randomly to receive either active vaccine or placebo. For every two participants assigned to active vaccine, one participant will be assigned to placebo vaccine.
- Participants will get a Vaccine Report Card to to complete after receiving vaccine.
- The study lasts 96 weeks.
Detailed description
TARP
- T-cell receptor g alternate reading frame protein (TARP) is a 58 amino acid protein expressed by both normal and malignant prostate cancer tissue; 95% of prostate cancer specimens are positive for TARP expression. TARP is highly expressed in prostate cancers of all Gleason types, in primary as well as metastatic disease, and in hormone sensitive and castrate resistant prostate cancer. Therefore, TARP is an ideal tumor antigen target for a vaccine.
- A prospective, randomized pilot study of 1st generation TARP Peptide vaccination (National Cancer Institute (NCI) 09-C-0139) utilizing TARP WT 27-35 and EE29-37-9V peptides was conducted in human leukocyte antigen serotype within the HLA-A serotype group (HLA-A 0201) positive men with stage D0 prostate cancer (prostate specific antigen (PSA) biochemical recurrence) and a PSA doubling time (PSADT) of greater than or equal to 3 months and less than or equal to 15 months. TARP vaccination was found to be immunogenic, safe and well tolerated, with adverse events limited to injection site reactions less than or equal to Grade 2. TARP vaccination was also associated with a decreased slope log PSA compared to pre-vaccination baseline in 72% of subjects reaching 24 weeks and 74% reaching 48 weeks (p=0.0012 and p=0.0004 for overall changes in slope log PSA, respectively); TARP vaccination also resulted in a 50% decrease in calculated tumor growth rate constant: pre-vaccine g = 0.0042/day, post-vaccine g = 0.0021/day (p=0.003); TARP-specific interferon gamma (IFN-g) enzyme-linked immune absorbent spot (ELISPOT) responses were detected in the majority of subjects but did not correlate with decreases in slope log (PSA).
Multi-Epitope (ME) TARP Vaccine
- The vaccine platform includes the original two 9-mer HLA-A*0201 binding TARP peptide epitopes (WT27-35 and EE29-37-9V) utilized in NCI 09-C-0139 as well as an additional five 20-mer TARP peptides overlapping by 10 amino acids for a total of 7 peptides that span the amino acid sequence of the entire TARP protein.
- The advantage of this multi-epitope TARP peptide vaccine platform is that the overlapping epitopes cover the entire TARP protein, resulting in potential for induction of a multi-valent anti-TARP response. In addition, these longer synthetic peptides include TARP-specific major histocompatibility complex (MHC)class II cluster of differentiation 4 (CD4)+ T cell helper epitopes that will allow generation of better cluster of differentiation 8 (CD8)+ T cell responses with improved functional avidity and longevity as well as humoral anti-TARP antibody responses.
Study Objectives:
Primary:
-To assess the difference in the slope log (PSA) for Weeks3-24 minus that formed for the 12 months prior to enrollment on study (referred to as slope324 pre-slope) as well as the slope log (PSA) for weeks 3-48 versus the same pre-treatment slope log (PSA) (referred to as slope 348 preslope) in patients na(SqrRoot) ve to TARP vaccination receiving active, multi-epitope TARP vaccination vs. placebo.
Eligibility:
- Males greater than or equal to 18 years of age with histologically confirmed adenocarcinoma of the prostate.
- Stage D0 disease with documented biochemical progression documented by rising PSA and no evidence of metastatic disease by physical examination, computed tomography (CT) scan or bone scan.
- Prostate specific antigen doubling time (PSADT) greater than or equal to 3 months and less than or equal to 15 months: ----Patients must have greater than or equal to 3 PSA measurements over greater than or equal to 3 months. --- The interval between PSA measurements must be greater than or equal to 4 weeks.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) 0-1.
- No other concurrent anticancer therapy or prior prostate cancer vaccines expressing TARP.
Study Design:
- Phase II, prospective, single-blinded, randomized, placebo controlled study of 96 weeks duration in men with Stage D0 prostate cancer. Men with a PSADT greater than or equal to 3 months and less than or equal to 15 months will be randomized 2:1 to receive multi-epitope (ME) TARP autologous dendritic cell (DC) vaccination or a control eleutriated monocyte vaccine placebo.
- An initial lead-in of 6 patientswill be enrolled to allow preliminary assessment of the safety of the ME TARP vaccine platform through 12 weeks before enrollment of prospectively randomized subjects blinded to treatment assignment begins.
- All patients will receive a total of 6 doses of vaccine (20 x10(6) viable cells/dose) delivered intradermally at Weeks 3, 6, 9, 12, 15, and 24. All patients will undergo a 15-18L apheresis at Week 0 and restaging at Weeks 48 and 96 to confirm maintenance of Stage D0 disease.
Sample size: N = 72 (6 lead-in patients for safety assessment, 2:1 randomization: TARP N = 44; placebo N =22).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1/Lead-in T-cell Receptor g Alternate Reading Frame Protein Dendritic Cell (DC) Vaccine Treatment | Experimental | Biological: Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccineAll patients to receive autologous multi-epitope T-cell receptor g alternate reading frame protein (TARP) DC vaccine before randomization |
| 2/Active T-cell Receptor g Alternate Reading Frame Protein Dendritic Cell (DC) Vaccine Treatment | Experimental | Biological: Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccineAutologous multi-epitope T-cell receptor g alternate reading frame protein (TARP) DC vaccine after randomization |
| 3/Placebo | Placebo comparator | Biological: Autologus elutriated monocyte placebo vaccineAutologous elutriated monocyte vaccine placebo after randomization |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Patients with an active second malignancy other than adequately treated squamous or basal cell carcinoma of the skin.
- Patients with active infection.
- Patients on immunosuppressive therapy including:
- Other significant or uncontrolled medical illness. Patients with a remote history of asthma or active mild asthma may participate.
- Patients who, in the opinion of the Principal Investigator, have significant medical or psychosocial problems that warrant exclusion
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 |
|---|---|---|
| Autologus elutriated monocyte placebo vaccine20x10^6 viable cells/dose at weeks 3, 6, 9, 12, 15 and 24 | Biological | 3/Placebo |
| Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccine20x10^6 viable cells/dose at weeks 3, 6, 9, 12, 15 and 24 | Biological | 1/Lead-in T-cell Receptor g Alternate Reading Frame Protein Dendritic Cell (DC) Vaccine Treatment, 2/Active T-cell Receptor g Alternate Reading Frame Protein Dendritic Cell (DC) Vaccine Treatment |
Primary outcome
Change in the Slope Log of Prostate-specific Antigen Pre vs Post Treatment
Time frame: One year pre-enrollment; weeks 3-24, and 3 - 48 post vaccine
PSA Doubling Time (PSADT) and slope log (PSA) were calculated at every study visit using the PSADT Memorial Sloane Kettering nomogram. The values were calculated to demonstrate the rate of rise of PSA, expressed as the velocity in nanograms/mL/year, or the PSA doubling time, in months or years. PSA is a tumor marker for prostate cancer and after surgery (undetectable - e.g. <0.2 ng/mL) or radiation PSA should fall to a very low level when the disease is effectively treated. When PSA increases (>2.0 ng/mL) after surgery or radiation that could mean recurrence of the disease. If prostate cancer is growing slower or shrinking after the treatment, PSADT can be longer while PSA slope log is shorter as tumor will make less PSA.
1 secondary outcome
Progression Free Survival (PFS)
Time frame: Week 96 after initial vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request. All collected individual participant data (IPD) will be shared with collaborators under the terms of collaborative agreements.
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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.
Hoyoung M Maeng, M.D. principal investigator
National Cancer Institute (NCI)
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 Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccine in people with Prostatic Neoplasms and Prostate Cancer, run by National Cancer Institute (NCI) 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 0 inclusion and 6 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: stopped early, as of the sponsor's last update on 18 Mar 2022. 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. 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.
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?
Yes. Results are posted in the registry (first posted 8 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in the Slope Log of Prostate-specific Antigen Pre vs Post Treatment (time frame: One year pre-enrollment; weeks 3-24, and 3 - 48 post vaccine). 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 18 Mar 2022.