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Immunostimulant

Radical Prostatectomy for Prostate Cancer

Phase 2
Waitlist Available
Led By Gurkamal S Chatta
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing aspirin, rintatolimod, and interferon-alpha 2b to treat prostate cancer before surgery. The goal is to see if they can keep the cancer from coming back and slowing tumor growth.

Eligible Conditions
  • Prostate Cancer
  • Prostate Adenocarcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Count of tumor infiltrating CD8+ lymphocytes
Secondary outcome measures
Incidence of treatment-related adverse events
Number of patients with Surgical margin positivity
PSA response
+1 more

Side effects data

From 2021 Phase 2 trial • 86 Patients • NCT03279250
74%
Hot flashes
71%
Fatigue
44%
Anemia
38%
Hyperglycemia
26%
AST increase
26%
Hypertension
26%
Lipase increase
24%
ALT increase
24%
Dry skin
21%
Rash
18%
ACTH increase
18%
Cholesterol high
15%
Amylase increase
15%
Dizziness
12%
Memory impairment
12%
White blood cell decrease
12%
Constipation
12%
Lymphocyte count decrease
9%
Myalgia
9%
Paresthesia
9%
Weight loss
9%
Arthralgia
9%
Hypothyrodism
9%
LDH increase
6%
Personality change
6%
Erectile dysfunction
6%
Headache
6%
Dysgeusia
6%
Dyspnea
6%
HbA1c increased
6%
Hypertriglyceridemia
6%
Insomnia
6%
Irritability
3%
Anxiety
3%
Atrial fibrillation
3%
Bruising
3%
Anorexia
3%
Hypercalcemia
3%
Dehydration
3%
TSH increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (LHRHa, Apalutamide, Abiraterone Acetate)
Arm A (LHRHa, Apalutamide)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (aspirin, rintatolimod, surgery)Experimental Treatment3 Interventions
Patients receive aspirin PO BID on days -7 to 7 and rintatolimod IV over 2 hours on days 1-3,and 8-10 in the absence of disease progression or unacceptable toxicity. Patients then undergo radical prostatectomy on or between day 17-24.
Group II: Arm I (aspirin, interferon alpha, rintatolimod, surgery)Experimental Treatment4 Interventions
Patients receive aspirin PO BID on days -7 to 7. Patients also receive recombinant interferon alfa-2b IV over 20 minutes and rintatolimod IV over 2 hours on days 1-3 and 8-10 in the absence of disease progression or unacceptable toxicity. Patients then undergo radical prostatectomy on or between day 17-24..
Group III: Arm III (radical prostatectomy)Active Control1 Intervention
Patients undergo radical prostatectomy about 4 weeks after enrollment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radical Prostatectomy
2005
Completed Phase 2
~4550
Rintatolimod
2019
Completed Phase 2
~120
Recombinant Interferon Alfa-2b
2019
Completed Phase 2
~150
Aspirin
2014
Completed Phase 4
~55580

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,828 Total Patients Enrolled
20 Trials studying Prostate Cancer
636 Patients Enrolled for Prostate Cancer
AIM ImmunoTech Inc.Industry Sponsor
14 Previous Clinical Trials
678 Total Patients Enrolled
Gurkamal S ChattaPrincipal InvestigatorRoswell Park Cancer Institute
3 Previous Clinical Trials
62 Total Patients Enrolled

Frequently Asked Questions

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

Are new patients welcome to enroll in this clinical trial?

"The clinical trial is currently seeking enrolment from patients. The first posting was on 29th November 2019 with the latest update happening on 12th October 2020."

Answered by AI

What are the usual motivations for a Radical Prostatectomy?

"While Radical Prostatectomy is commonly used as a pain management strategy, this surgical intervention can also be used to ameliorate other conditions such as myocardial infarction, catarrh, hepatitis c virus (hcv) infection."

Answered by AI

How many study volunteers are participating in this research?

"Yes, this is an ongoing trial that was first posted on 29 November 2019. The listing was last updated 12 October 2022 and the study seeks 45 patients at a single site."

Answered by AI

Is there a heightened risk for complications with Radical Prostatectomy?

"There is some data supporting Radical Prostatectomy's safety, but none yet for efficacy. It received a score of 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Aspirin and Rintatolimod With or Without Interferon-alpha 2b in Treating Patients With Prostate Cancer Before Surgery
2019. "Aspirin and Rintatolimod With or Without Interferon-alpha 2b in Treating Patients With Prostate Cancer Before Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03899987.
~1 spots leftby May 2024
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