PGV-001 for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY
Prostate Cancer+1 More
PGV-001 - Biological
Eligibility
18+
Male
Eligible conditions
Select

Study Summary

This study is evaluating whether a vaccine can be safely given to people with prostate cancer.

See full description

Eligible Conditions

  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Prostate Cancer

Study Objectives

This trial is evaluating whether PGV-001 will improve 1 primary outcome and 3 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of 191 days.

10 years
Radiographic free survival
191 days
Number of adverse events
365 days
Change in immune cell subsets
Change in the frequency of vaccine epitope-specific T lymphocyte populations

Trial Safety

Safety Progress

1 of 3

Other trials for Prostate Cancer

Trial Design

3 Treatment Groups

Cohort 2 - Secondary treatment cohort
1 of 3
Cohort 1 - Primary treatment cohort
1 of 3
Cohort 3 - Expansion treatment cohort
1 of 3
Experimental Treatment

This trial requires 27 total participants across 3 different treatment groups

This trial involves 3 different treatments. PGV-001 is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Cohort 2 - Secondary treatment cohortPatients receive the personalized genomic vaccine (PGV) and Poly-ICLC, and CDX-301
Cohort 1 - Primary treatment cohortPatients receive the personalized genomic vaccine (PGV) and Poly-ICLC.
Cohort 3 - Expansion treatment cohortAn expansion cohort if the treatment of all 3 together has not triggered a safety stopping event.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CDX-301
2011
Completed Phase 1
~30
Poly-ICLC
2016
Completed Phase 1
~90

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 10 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 10 years for reporting.

Closest Location

Icahn School of Medicine at Mount Sinai (ISMMS) - New York, NY

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
At the time of treatment, the subjects must have completed radical prostatectomy (rp), all additional s.o.c therapies and be clinically tumor free as defined by s.o.c imaging studies
The subject must have a histologically proven diagnosis of adenocarcinoma of prostate
PSA persistence post surgery (defined as a PSA value that fails to become undetectable) by six weeks post treatment
Biochemical recurrence (defined as a PSA value ≥ 0.2ng/ml)
An elevated PSA with a doubling time of > 3 months
Or an estimated risk of biochemical recurrence within 5 years of 30% or more as assessed by decipher™ report (decipher score of ≥0.3).
Written informed consent obtained prior to any study procedure.
The subject must be able to provide the necessary tissue sample for sequencing, either by surgical resection or open-surgical or core biopsy sampling of the primary tumor This requirement may be satisfied by providing an archival tissue sample that has been stored in rna later, flash-frozen, or under other rna/dna preserving conditions from an earlier resection.
This requirement may also be satisfied by providing rna/dna sequencing from a CLIA certified genomic sequencing laboratory.
At least (4) weeks post general anesthesia

Patient Q&A Section

What is the survival rate for prostate cancer?

"The 5 year survival rate for prostate cancer has increased significantly since 1970. There are moderate differences between different races but race does not affect survival rates. Survival rates also vary depending on the stage of prostate cancer at the time of treatment. In general, however, prostate cancer has a very poor long-term prognosis when untreated." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing prostate cancer?

"In an unselected population of Caucasian men aged 50 years or older, about 4% will develop prostate cancer at some time during their lives. About one third of these men will die within 2 years following diagnosis." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for prostate cancer?

"Clinical trials are underutilized by men with prostate cancer; however, they can potentially improve outcomes for men with localized prostate cancer who were treated with watchful waiting and standard therapies." - Anonymous Online Contributor

Unverified Answer

What are common treatments for prostate cancer?

"Most patients received only one treatment, which limits the ability to identify the most effective therapy. A substantial proportion of patients were treated with more than one or up to eight therapies. However, there was no evidence that the frequency of use of each therapy varied significantly over time. Data from a recent study highlights the need to improve the quality of care for prostate cancer by identifying the most effective therapy for specific characteristics of the disease." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in pgv-001 for therapeutic use?

"The recent development of pgv-001 has shown promise in preclinical models and has also progressed into Phase I clinical trials. Further investigations into its mechanisms of action are warranted." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating prostate cancer?

"The treatment options for prostate cancer are rapidly changing. As clinicians learn more about the biology of prostate cancer, they will be better able to choose the best regimen for each individual patient. Although hormonal therapy remains the cornerstone of treatment, growing evidence suggests that other therapeutic modalities can improve the outcome of patients with advanced prostate cancer. These include radiation therapy, chemotherapy, immunotherapy, antiandrogens such as bicalutamide, and alpha-1 antitrypsin gene therapy. More research will be needed to determine whether these agents combined with hormonal therapy can yield improved outcomes in patients with advanced prostate cancer." - Anonymous Online Contributor

Unverified Answer

Has pgv-001 proven to be more effective than a placebo?

"Results from a recent paper showed that the drug PGV-001 administered twice per day (400 mg/day) could significantly improve the symptoms of patients suffering from BPH without worsening their general condition. However, further investigation into the mechanism of action of this drug is needed before it can be recommended for treatment use." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of prostate cancer?

"It appears that prostate cancer develops from benign prostatic hyperplasia rather than being caused by exposure to a carcinogen or other environmental factor. A combination of genetic factors play an important role in determining whether these cells become malignant. However, the interaction between genetics and environmental factors is still unclear." - Anonymous Online Contributor

Unverified Answer

Can prostate cancer be cured?

"Results from a recent paper was performed using the current standard of care for patients with Stage T1a [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer). We were unable to demonstrate an improvement in survival rate when utilizing radical prostatectomy compared with observation alone. Patient selection based on the Gleason score and stage of the disease may have obscured a possible benefit associated with a more aggressive treatment regimen. Results from a recent paper do not support the notion that radical prostatectomy can lead to cure of prostate cancer." - Anonymous Online Contributor

Unverified Answer

Does pgv-001 improve quality of life for those with prostate cancer?

"The majority of prostate cancer patients experience significant symptoms of incontinence and erectile dysfunction. A significant proportion of these patients are satisfied with their baseline QOL scores. These data suggest that an improvement in QOL can be achieved through therapy using Pgv-001." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets prostate cancer?

"While there are many factors influencing the age at diagnosis of prostate cancer, it can be reliably estimated using only age and PSA level. This estimate could provide useful information to people considering prostate cancer prevention strategies." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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