← Back to Search

Cancer Vaccine

Sipuleucel-T for Early-Stage Prostate Cancer (ProVent Trial)

Phase 3
Waitlist Available
Research Sponsored by Dendreon
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histologically proven adenocarcinoma of the prostate initially diagnosed ≤12 months of Screening. All biopsy slides with subject information redacted must be submitted for BICR.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up once all subjects have completed at least 3 years following randomization
Awards & highlights

ProVent Trial Summary

This trial is testing if a drug can help extend life for men with early stage prostate cancer who are not yet candidates for surgery or radiation.

Who is the study for?
Men over 18 with newly diagnosed low-risk prostate cancer, eligible for curative therapy if needed. They must have a life expectancy of at least 10 years and be able to undergo biopsies. Excluded are those who've had prior prostate cancer treatments, significant surgical alterations to the prostate, other recent cancers (except certain skin cancers), or conditions like uncontrolled heart disease.Check my eligibility
What is being tested?
The ProVent study is testing sipuleucel-T in men with early-stage prostate cancer under active surveillance. The goal is to see if this treatment can slow down the progression of their cancer compared to just monitoring it without any intervention.See study design
What are the potential side effects?
While specific side effects for sipuleucel-T aren't listed here, similar immunotherapies can cause flu-like symptoms, injection site reactions, fatigue, fever, chills and sometimes more serious immune-related issues.

ProVent Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My prostate cancer was diagnosed within the last year.
Select...
I am 18 years old or older.

ProVent Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~once all subjects have completed at least 3 years following randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and once all subjects have completed at least 3 years following randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Malignant Neoplasms

Side effects data

From 2004 Phase 3 trial • 127 Patients • NCT00005947
62%
Chills
44%
Fatigue
34%
Pyrexia
22%
Back pain
17%
Headache
17%
Dyspnoea
16%
Paraesthesia
15%
Nausea
15%
Arthralgia
12%
Vomiting
11%
Constipation
11%
Asthenia
11%
Chest wall pain
10%
Feeling cold
10%
Tremor
9%
Pain in extremity
9%
Anaemia
9%
Anorexia
9%
Myalgia
7%
Diarrhoea
7%
Oedema peripheral
7%
Weight decreased
7%
Upper respiratory tract infection
7%
Shoulder pain
6%
Haematuria
6%
Influenza like illness
6%
Pain
6%
Neck pain
6%
Groin pain
6%
Muscle spasms
5%
Cough
5%
Urinary retention
5%
Dyspepsia
2%
Flushing
2%
Dysuria
2%
Cerebrovascular accident
2%
Spinal cord compression
1%
Atrial fibrillation
1%
Pollakiuria
1%
Catheter sepsis
1%
Chest pain
1%
Dehydration
1%
Glioblastoma
1%
Haemorrhage intracranial
1%
Pleural effusion
1%
Transient ischaemic attack
1%
Urinary tract infection
1%
White blood cell count increased
1%
Hypokalaemia
1%
Hypoxia
1%
Myocardial infarction
1%
Pathological fracture
1%
Pleuritic pain
1%
Retinal detachment
1%
Sepsis
1%
Syncope
1%
Transaminases increased
1%
Contusion
1%
Gait disturbance
1%
Blood creatinine increased
1%
Cardiac failure congestive
1%
Catheter related infection
1%
Hyperhidrosis
1%
Lumbar radiculopathy
1%
Insomnia
1%
Aphasia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sipuleucel-T
Placebo

ProVent Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment Group: Sipuleucel-TExperimental Treatment1 Intervention
Sipuleucel-T is an autologous cellular immunotherapy available as a suspension for intravenous infusion. Subjects randomized to sipuleucel-T arm will receive 3 infusions of sipuleucel-T at approximately 2-week intervals.
Group II: Control Arm: Active SurveillanceActive Control1 Intervention
Subjects randomized to the control arm will be followed on Active Surveillance described in the schedule of events.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
sipuleucel-T
2012
Completed Phase 3
~2770

Find a Location

Who is running the clinical trial?

PRA Health SciencesIndustry Sponsor
94 Previous Clinical Trials
35,841 Total Patients Enrolled
DendreonLead Sponsor
29 Previous Clinical Trials
4,693 Total Patients Enrolled
15 Trials studying Prostate Cancer
1,485 Patients Enrolled for Prostate Cancer
Bruce Brown, MDStudy DirectorDendreon Pharmaceuticals LLC
4 Previous Clinical Trials
2,392 Total Patients Enrolled
1 Trials studying Prostate Cancer
139 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research unique in any way?

"As of now, sipuleucel-T is only being trialed in 50 cities spread out over a single nation. The first trial began in 2018 and was completed successfully in its Phase 3 drug approval stage. In the two years since, there have been 24 more trials."

Answered by AI

Are there precedent cases for sipuleucel-T research?

"Sipuleucel-T was first studied in 2018 at Adult Pediatric Urology and Urogynecology - Omaha. There have been a total of 24 completed clinical trials to date. Currently, there is 1 active study, which is based in Tucson, Arizona."

Answered by AI

Could you please tell me how many different locations are participating in this trial today?

"This trial is currently enrolling patients at 56 sites. The sites are based in Tucson, San Antonio and Roswell to name a few 56 other locations. It is helpful to select the clinic nearest you to minimize travel requirements if you participate."

Answered by AI

How many people are signed up to participate in this experiment?

"Right now, this study isn't enrolling patients. It was first posted on October 18th, 2018 and was last edited on January 18th, 2022. If you're interested in other trials, there are 789 other trials for adenocarcinoma and 1 trial for sipuleucel-T that are currently looking for patients."

Answered by AI

To what extent does sipuleucel-T represent a health hazard?

"Sipuleucel-T is classified as a Phase 3 drug, meaning that while there is some evidence of efficacy, more data is needed to support its use. However, multiple rounds of data have been collected supporting its safety, so it receives a score of 3."

Answered by AI

Are we still looking for test subjects for this experiment?

"Unfortunately, this particular study is not looking for patients at the moment. However, there are 790 other medical trials that are currently open for enrolment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer
2018. "Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03686683.
~69 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top