Adoptive Transfer of Autologous T Cells Targeted to Prostate Specific Membrane Antigen (PSMA) for… (NCT01140373) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Adoptive Transfer of Autologous T Cells Targeted to Prostate Specific Membrane Antigen (PSMA) for the Treatment of Castrate Metastatic Prostate Cancer (CMPC)
United States13 participantsStarted 2010-06
Plain-language summary
This is a phase I study which will test the safety of different doses of the patients own immune cells which have been changed to help recognize and destroy the cancer cells. The investigators want to find out what effects, good and/or bad, it has on the body and on the prostate cancer. The immune cells (T cells) used in this study will be the patients own immune cells. They will be removed from the patients blood, changed in the laboratory, and then put back into their body. T cells help the body fight infections. These cells may also kill cancer cells in some cases. Right now the patients T cells are unable to kill the cancer cells. For this reason, the physician will change the T cells by putting in a gene so that they may be able to better recognize and kill the prostate cancer cells. A gene is a portion of information which comes from the DNA and tells the cell what to do. This gene will be put into the patients T cells by a weakened virus. It is hoped that this approach will help the T cells recognize the prostate cancer tumor cells and possibly kill them. The investigators have found that T cells modified in this way were able to cure a cancer similar to Chronic Lymphocytic Leukemia in mice. However, this is an entirely new treatment for prostate cancer and it is not known if it will have any beneficial or unexpected harmful effects.
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:
* Male, over 18 years of age
* Karnofsky Performance Scale (KPS) greater or = to 70%
* Histologic confirmation of prostate cancer at Memorial Sloan-Kettering Cancer Center (MSKCC)
* A diagnosis of progressive castrate metastatic prostate cancer defined as one or more of the following three criteria:
* Soft tissue progression defined by RECIST 1.0
* Bone disease progression defined by PCWG2 with two or more new lesions on bone scan
* Post-hormonal therapy rising PSA values from a hormone therapy nadir on greater or = to 3 successive determinations at least two weeks apart, where the increase above the nadir is the greater of greater or = to 2.0 ng/mL or a greater or = to 10% change (Subjects with a rise in PSA but no evidence of metastases at any time by imaging studies will NOT be eligible.)
* For subjects who have discontinued anti-androgen therapy, PSA rise as defined above must be documented:
* Within two weeks after discontinuation if used following surgical or medical castration (second line therapy)
* After four weeks discontinuation if used as first line therapy.
* Evidence of metastatic disease in bone on bone scan, CT scan, and/or by MRI atany time following the initial diagnosis of prostate cancer.
* Castrate level of serum testosterone (\<50 ng/mL) achieved by prior hormonal therapy consisting of either a) orchiectomy or b) luteinizing hormone-releasing hormone (LHRH) agonists with or without an anti-androgen
* Castrate level of serum testoster…
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.