Prostate CancerPhase 2NCT01341652
Phase II PAP Plus GM-CSF Versus GM-CSF Alone for Non-metastatic Prostate Cancer
A Phase 2 study testing pTVG-HP and rhGM-CSF in people with Prostate Cancer, run by University of Wisconsin, Madison at 3 sites in United States.
Trial summary
The investigators are trying to find new methods to treat prostate cancer. The approach the investigators are taking is to try to enhance patients' own immune response against the cancer. 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?
- pTVG-HP and rhGM-CSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 May 2011to 30 Jun 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
- Histologic diagnosis of adenocarcinoma of the prostate
- Completion of local therapy by surgery and/or ablative radiation therapy at least 3 months prior to entry, with removal or ablation of all visible disease, including seminal vesical and/or local lymph node involvement
- Rising prostate specific antigen (PSA) levels without scan evidence of metastatic disease
- Asymptomatic or mildly symptomatic and life expectancy of at least 4 months
Who cannot join
- Small cell or other variant prostate cancer histology
- Evidence of immunosuppression
- Prior treatment with androgen deprivation except if given neoadjuvantly or adjuvantly with radiation therapy or at time of prostatectomy. In this situation, no more than 24 months of androgen deprivation must have been given and treatment must not have been within 12 months prior to screening for this study.
- Serum testosterone at screening < 50 ng/dL
- Known bone metastases or lymph node involvement as determined by bone scan or computed tomography (CT) scan of the abdomen and pelvis within 4 weeks of study entry
- Prior vaccine therapy for prostate cancer
- Known allergic reactions to granulocyte-macrophage colony-stimulating factor (GM-CSF)
- Severe intercurrent medical conditions or laboratory abnormalities that would impart, in the judgment of the Medical Monitor, excess risk associated with study participation or study agent administration
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Official title: Randomized Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP) Versus GM-CSF Adjuvant in Patients With Non-Metastatic Prostate Cancer
The investigators are trying to find new methods to treat prostate cancer. The approach the investigators are taking is to try to enhance patients' own immune response against the cancer. In this study the investigators will be testing the effectiveness of a vaccine that may be able to help the body fight prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- pTVG-HP, rhGM-CSF
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pTVG-HPBiological
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
rhGM-CSFBiological
Also called GM-CSF, granulocyte-macrophage colony-stimulating factor
rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
| Study group | Role | What they receive |
|---|---|---|
| pTVG-HP vaccine with GM-CSF | Experimental | pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period Receives: Biological: pTVG-HP |
| GM-CSF alone | Active comparator | rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period Receives: Biological: rhGM-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year Metastasis-Free Survival Rate
2-year Metastasis-Free Survival (MFS) Rate with the development of metastases by conventional imaging used to define progression (as defined by RECIST 1.1 criteria). The 2-year MFS rate estimates which were obtained using the Kaplan-Meier analysis (taking into account censoring) using the intention-to-treat population.
Measured: 2 years
Secondary outcomes (4)
Prostate Specific Antigen (PSA) Doubling Time (DT)
PSA DT was calculated using all serum PSA values available from the same clinical laboratory for the specified period by the equation log2/b where b denotes the least-squares estimator of the linear regression model of the log-transformed PSA values on time. Pretreatment PSA DT (3-6 months before treatment, with a minimum of 4 values), on-treatment PSA DT was determined using values from month 3 to month 9.
Measured: up to 9 months
Number and Severity of Observed Toxicities
Number of participants who experienced any adverse events greater than grade 1 that were determined to be at least possibly related to treatment, highest grade reported per participant for each adverse event (AE). All toxicities were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (version 4). Higher grades indicate more severe toxicities.
Measured: 2 years
Median Time to Radiographic Disease Progression
Time to metastasis was determined from the date of registration to the first CT or bone scan that demonstrated metastatic disease. As defined by RECIST 1.1 criteria.
Measured: up to 2 years
PSA Progression Free Survival
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2011 (estimated)
- Study start23 May 2011
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas McNeel, M.D., PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341652
- Sponsor's protocol ID
- CO08801
- Other IDs
- 2013-1679, NCI-2011-00965, A534260, SMPH/MEDICINE/MEDICINE*H, Protocol Version 10/7/2015
- Status last verified
- Jan 2021
- First submitted
- 24 Mar 2011
- Last updated
- 20 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
McNeel DG, Eickhoff JC, Johnson LE, Roth AR, Perk TG, Fong L, Antonarakis ES, Wargowski E, Jeraj R, Liu G. Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP [MVI-816]) in Patients With Progressive, Nonmetastatic, Castration-Sensitive Prostate Cancer. J Clin Oncol. 2019 Dec 20;37(36):3507-3517. doi: 10.1200/JCO.19.01701. Epub 2019 Oct 23.
PubMed 31644357
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP) Versus GM-CSF Adjuvant in Patients With Non-Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT01341652
- Acronym / sponsor ID
- CO08801
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 23 May 2011 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 26 Apr 2011 (estimated)
- Results
- Posted 25 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are trying to find new methods to treat prostate cancer. The approach the investigators are taking is to try to enhance patients' own immune response against the cancer. In this study the investigators will be testing the effectiveness of a vaccine that may be able to help the body fight prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pTVG-HP vaccine with GM-CSF | Experimental | Biological: pTVG-HPpTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period |
| GM-CSF alone | Active comparator | Biological: rhGM-CSFrhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologic diagnosis of adenocarcinoma of the prostate
- Completion of local therapy by surgery and/or ablative radiation therapy at least 3 months prior to entry, with removal or ablation of all visible disease, including seminal vesical and/or local lymph node involvement
- Rising prostate specific antigen (PSA) levels without scan evidence of metastatic disease
- Asymptomatic or mildly symptomatic and life expectancy of at least 4 months
Key exclusion criteria (8 listed)
- Small cell or other variant prostate cancer histology
- Evidence of immunosuppression
- Prior treatment with androgen deprivation except if given neoadjuvantly or adjuvantly with radiation therapy or at time of prostatectomy. In this situation, no more than 24 months of androgen deprivation must have been given and treatment must not have been within 12 months prior to screening for this study.
- Serum testosterone at screening < 50 ng/dL
- Known bone metastases or lymph node involvement as determined by bone scan or computed tomography (CT) scan of the abdomen and pelvis within 4 weeks of study entry
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 |
|---|---|---|
| pTVG-HPpTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period | Biological | pTVG-HP vaccine with GM-CSF |
| rhGM-CSFAlso: GM-CSF, granulocyte-macrophage colony-stimulating factorrhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period | Biological | GM-CSF alone |
Primary outcome
2-year Metastasis-Free Survival Rate
Time frame: 2 years
2-year Metastasis-Free Survival (MFS) Rate with the development of metastases by conventional imaging used to define progression (as defined by RECIST 1.1 criteria). The 2-year MFS rate estimates which were obtained using the Kaplan-Meier analysis (taking into account censoring) using the intention-to-treat population.
4 secondary outcomes
Prostate Specific Antigen (PSA) Doubling Time (DT)
Time frame: up to 9 months
Number and Severity of Observed Toxicities
Time frame: 2 years
Median Time to Radiographic Disease Progression
Time frame: up to 2 years
PSA Progression Free Survival
Time frame: up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31644357McNeel DG, Eickhoff JC, Johnson LE, Roth AR, Perk TG, Fong L, Antonarakis ES, Wargowski E, Jeraj R, Liu G. Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP [MVI-816]) in Patients With Progressive, Nonmetastatic, Castration-Sensitive Prostate Cancer. J Clin Oncol. 2019 Dec 20;37(36):3507-3517. doi: 10.1200/JCO.19.01701. Epub 2019 Oct 23.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
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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.
Douglas McNeel, M.D., PhD principal investigator
University of Wisconsin, Madison
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pTVG-HP and rhGM-CSF in people with Prostate Cancer, run by University of Wisconsin, Madison at 3 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 4 inclusion and 8 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 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 25 Nov 2020). 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?
2-year Metastasis-Free Survival Rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01341652, which also lists 1 linked publication.
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 20 Jan 2021.