Disease: Prostate Cancer, (NCT03525652)

Disease info:

Prostate cancer is cancer that occurs in the prostate. The prostate is a small walnut-shaped gland in males that produces the seminal fluid that nourishes and transports sperm. Prostate cancer is one of the most common types of cancer. Many prostate cancers grow slowly and are confined to the prostate gland, where they may not cause serious harm. However, while some types of prostate cancer grow slowly and may need minimal or even no treatment, other types are aggressive and can spread quickly.

Prostate cancer may cause no signs or symptoms in its early stages. Advanced prostate cancer may lead to various symptoms, including:

  • Trouble urinating
  • Decreased force in the stream of urine
  • Blood in the urine
  • Blood in the semen
  • Bone pain
  • Losing weight without trying
  • Erectile dysfunction

Researchers have found several factors that might affect a man’s risk of getting prostate cancer. Those are age, race/ ethnicity, family history, geography and gene changes. Several inherited mutated genes have been linked to hereditary prostate cancer, including:

  • BRCA1 and BRCA2: These tumor suppressor genes normally help repair mistakes in a cell’s DNA (or cause the cell to die if the mistake can’t be fixed). Inherited mutations in these genes more commonly cause breast and ovarian cancer in women. But changes in these genes (especially BRCA2) also account for a small number of prostate cancers.
  • CHEK2ATMPALB2, and RAD51D: Mutations in these other DNA repair genes might also be responsible for some hereditary prostate cancers.
  • DNA mismatch repair genes (such as MSH2MSH6MLH1, and PMS2): These genes normally help fix mistakes (mismatches) in DNA that can be made when a cell is preparing to divide into 2 new cells. (Cells must make a new copy of their DNA each time they divide.) Men with inherited mutations in one of these genes have a condition known as Lynch syndrome (also known as hereditary non-polyposis colorectal cancer, or HNPCC), and are at increased risk of colorectal, prostate, and some other cancers.
  • RNASEL (formerly HPC1): The normal function of this tumor suppressor gene is to help cells die when something goes wrong inside them. Inherited mutations in this gene might let abnormal cells live longer than they should, which can lead to an increased risk of prostate cancer.
  • HOXB13: This gene is important in the development of the prostate gland. Mutations in this gene have been linked to early-onset prostate cancer (prostate cancer diagnosed at a young age) that runs in some families. Fortunately, this mutation is rare.

Other inherited gene mutations may account for some hereditary prostate cancers, and research is being done to find these genes.

Prostate cancer that is detected early — when it's still confined to the prostate gland — has the best chance for successful treatment.

Frequency:
The American Cancer Society’s estimates for prostate cancer in the United States for 2021 are: About 248,530 new cases of prostate cancer. About 34,130 deaths from prostate cancer. About 6 cases in 10 are diagnosed in men who are 65 or older.
Official title:
Clinical Assessment of a Therapeutic Vaccine in Combination With PD-1 Knockout T Cells in the Treatment of Prostate Cancer
Who:

Principal Investigator: Size Chen, MD, PhD.  The First Affiliated Hospital of Guangdong Pharmaceutical University

Locations:

China, Guangdong

Study start:
Feb. 28, 2018
Enrollment:
30 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock out
Gene:
Programmed Cell Death 1 (PD-1)
Delivery method:
ex-vivo
IndicatorIndicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

This is a Phase 1/2 clinical study investigating the safety and efficacy of a therapeutic vaccine in combination with PD-1 knockout T cells in the treatment of advanced prostate cancer. The therapeutic vaccine is a customised product involving ex vivo treatment of the patient's peripheral blood mononuclear cells with a recombinant fusion protein (PAP-GM-CSF) to activate the expression of the antigen that would activate the immune function to kill cancer cells. The PD-1 knockout-engineered T cells are also prepared using patient T cells in which the PD-1 gene will be knocked out using CRISPR-Cas9 technology. The therapeutic vaccine and PD-1 knockout T cells will be infused back to the patient a total of three times within a 2-week interval.

Last updated: Jul. 11, 2021
Source: US National Institutes of Health (NIH)
clinicaltrials.gov
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