Title
Pilot Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP) and PD-1 Blockade, with Targeted Ablation of Resistant Lesions, in Patients with Non-Castrate Recurrent Oligometastatic Prostate Cancer

Description
Pilot Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP) and PD-1 Blockade, With Targeted Ablation of Resistant Lesions, in Patients With Non-Castrate Recurrent Oligometastatic Prostate Cancer

Objective
The goal of this clinical trial is to learn whether an experimental vaccine called pTVG-HP ("vaccine" or "DNA vaccine"), combined with a drug called nivolumab can increase the cancer-fighting ability of a person's immune cells.

The main question it aims to answer is whether the combination of medicines can get rid of metastatic tumors in participants with non-castrate, recurrent, oligometastatic prostate cancer.

Participants will undergo:

Treatment with pTVG-HP

Treatment with Nivolumab

Radiation Therapy

Treatment To explore the use of an investigational DNA vaccine, pTVG-HP, a plasmid DNA encoding human prostatic acid phosphatase (PAP), in combination with nivolumab delivered with vaccination, and in combination with targeted ablation of treatment-resistant lesions, to eradicate metastatic tumor lesions in patients with non-castrate, recurrent, oligometastatic prostate cancer.

Key Eligibility Inclusion Criteria:

Participants must be at least 18 years of age with a histologic diagnosis of adenocarcinoma of the prostate

Participants must have undergone radical prostatectomy

Participants must have completed local therapy by surgery, and any adjuvant/salvage radiation therapy (if required), at least 3 months prior to entry, with removal or ablation of all visible disease, including seminal vesical and/or local lymph node involvement.

Participants must have biochemically recurrent disease defined by the following:



Participants 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).



Participants must have oligometastatic disease, defined as:



< 3 lesions consistent with metastases as detected by CT of the abdomen/pelvis and bone scintigraphy (bone scan)

Lesions consistent with metastatic prostate cancer as detected by PSMA PET/CT



Participants with a prior history of a second malignancy are eligible provided they have been treated with curative intent and have been free of disease greater than three years. There will be no exclusion for patients with a history of basal cell carcinoma, squamous cell skin cancer, superficial bladder cancer, or other in situ carcinoma that has been adequately treated.

Participants who are sexually active must use a reliable form of contraception while on study and for 4 weeks after the last immunization.

ECOG performance score < 2 and life expectancy of at least 12 months.

Participants must have normal hematologic, renal and liver function

Participants must be informed of the experimental nature of the study and its potential risks and must sign an IRB-approved written informed consent form indicating such an understanding.

Willingness to provide blood samples for immune studies, per study calendar, up to one year after study, even if off treatment.

Applicable Disease Sites
Prostate

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital