pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer (NCT03600350) | Clinical Trial Compass
Active — Not RecruitingPhase 2
pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer
United States19 participantsStarted 2018-09-10
Plain-language summary
The purpose of this study is to evaluate the safety of an investigational DNA vaccine, pTVG-HP, a plasmid DNA encoding human prostatic acid phosphatase (PAP), in combination with nivolumab, and the efficacy of this combination in decreasing serum Prostate-Specific Antigen (PSA) in patients with non-metastatic, non-castrate prostate cancer (clinical stage D0/M0).
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must be at least 18 years of age with a histologic diagnosis of adenocarcinoma of the prostate
* Patients must have undergone radical prostatectomy
* Patients must have completed local therapy by surgery and any adjuvant/salvage 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.
* Patients must have biochemically recurrent, non-metastatic (by CT and bone scan) clinical stage D0/M0 disease defined by the following:
* Patients must have evidence of detectable serum PSA with at least 4 serum PSA measurements available, from the same clinical laboratory, at least two weeks apart up to one year, and the final serum PSA value must be \> 2.0 ng/mL.
* PSA doubling time, calculated from most recent 4 serum PSA values (collected up to one year prior to enrollment, at least 2 weeks apart, and all from the same clinical laboratory), must be a positive number (i.e. evidence of PSA rise over time).
* PSA doubling time will be calculated using the Memorial Sloan-Kettering Cancer Center nomogram (http://www.mskcc.org/applications/nomograms/prostate/PsaDoublingTime.aspx).
* Patients must not have definitive evidence of metastases as determined by CT of the abdomen/pelvis and bone scintigraphy (bone scan). Note: patients with lesions detectable by highly sensitive methods (e.g. NaF PET imaging or PSMA PET imaging) will be considered eligible …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Who Experienced Adverse Events Grade 3 or Higher