Hello fellow PC warriors.
In Jan 19 I completed combo treatment SBRT and Bicalutamide. My PSA started rising 5 months ago signaling BCR. Further testing PSMA PET / MRI confirmed reoccurring PC and my 15 core guided biopsy was mostly 4+5's, one 5+5 all grade group 5. Good news is that it's still contained to the capsule and there are no distant mets. Recommendation from my urology oncologist is Cryo therapy of the entire prostate.
I learned about a Clinical Trial on Cryo-Immune Focal + Systemic Immune Therapy. Are there any of you with knowledge of the trial cited below?
Thanks,
Ross
The clinical trial will evaluate the effectiveness of cryo-immunotherapy. 10 The current medical center is in Rochester, Michigan, but more sites should soon be open.
The trial design is as follows:
1. Identify an accessible location of tumor mass(es) inside or on the surface of the patient’s body.
2. Administer low-dose cyclophosphamide five days before the focal procedure to suppress a sub-population of lymphocytes (called Tregs) to further enhance T-cell destruction of cancer cells.
3. Use image-guided technology to precisely cryo-damage a portion of the malignant lesion.
4. Precisely inject into the tumor(s) two immune-therapeutic drugs:
a. Keytruda® (pembrolizumab), which is a monoclonal antibody drug that inhibits PD-1 (programmed death -1 receptor) and impedes a cancer cell’s ability to escape the body’s normal immune response. PLUS,
b. Yervoy® (ipilimumab), an anti-CTLA-4 (cytotoxic T-lymphocyte-associated antigen 4) monoclonal antibody drug that works to enhance the immune response by targeting a subset of T-cells called Tregs that inhibit the immune response.
5. The treatment also involves an immune drug called GM-CSF (granulocyte-macrophage colony stimulating factor) that has been used for decades to mobilize the bone marrow release of granulocytes and macrophages to protect against bone marrow suppression caused by toxic chemotherapy drugs. The objective in this cryo-immune clinical trial is to use GM-CSF to potentiate the effects of the immune checkpoint inhibitors Keytruda® and Yervoy®. The GM-CSF is given under the skin (subcutaneous) and is injected for about 30 days after cryo-immune focal therapy is administered.
6. Up to two cancer areas for each patient will be selected and treated during each treatment. The clinical trial will involve up to three treatments using the above approach for each patient.
By using a sequence of cryo-damaging the tumor (to release its antigens), followed by four different immune therapies (Keytruda® + Yervoy® + GM-CSF+ cyclo-phosphamide), a cryo-immune synergy is created, and some researchers believe that a clinically significant systemic anti-cancer immune response may be elicited.
Moreover, the intra-tumoral injection of drugs at a lower dose is likely to cause fewer side effects than higher-dose intravenous systemic therapy.
How to Determine if you Qualify for this Study
There is no cost to those eligible for the study other than possible travel expenses and lodging near the clinical trial study site medical facility. The study center may bill your insurance if it covers the cost of some laboratory tests and imaging, but patients are not expected to pay anything out of pocket.
If you or someone you know has a diagnosed metastatic malignancy involving a solid tumor and all available treatments have failed or the patient chooses against conventional therapy, you can register at the following website to ascertain your eligibility:
Additional information about the trial can be found at clinicaltrials.gov/ct2/show...
If you are eligible, you will be contacted for full medical records and a trial coordinator(s) will guide you through the trial process.
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