Testosterone cypionate for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Prostate Cancer+3 More
Testosterone cypionate - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial is testing whether giving testosterone and nivolumab to men with metastatic prostate cancer who have progressed on other treatments can help them.

Eligible Conditions
  • Prostate Cancer
  • Castration-resistant Prostate Cancer
  • Malignant Neoplasms

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 3 years

2 years
Durable Progression-Free Survival (Durable PFS) to Bipolar Androgen Therapy + Nivolumab
Objective Response Rate (ORR) to Bipolar Androgen Therapy + Nivolumab
PSA Progression-Free Survival (PSA-PFS) to Bipolar Androgen Therapy + Nivolumab
PSA Response to Bipolar Androgen Therapy + Nivolumab in patients with gene mutations
PSA Response to Bipolar Androgen Therapy + Nivolumab in patients without gene mutations
Progression-Free Survival (PFS) to Bipolar Androgen Therapy + Nivolumab
Prostate Specific Antigen (PSA) response to Bipolar Androgen Therapy + Nivolumab
Safety of Bipolar Androgen Therapy + Nivolumab As Determined by the Number of CTCAEs ≥ grade 3
2 years.
Correlation of Bipolar Androgen Therapy on the Production of Inflammatory Chemokines and Cytokines
PSA Correlation with DNA Damage Markers in Response to Bipolar Androgen Therapy + Nivolumab
PSA Correlation with Immune Markers in Response to Bipolar Androgen Therapy + Nivolumab
3 years
Clinical Response Association to Bipolar Androgen Therapy + Nivolumab as assessed by generation of mutation-associated neoantigens (MANAs)
Clinical Response Association to Bipolar Androgen Therapy + Nivolumab as assessed by the generation of tumor-associated neoantigens (TAAs)
Median Overall Survival (OS) to Bipolar Androgen Therapy + Nivolumab

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Cohort A:Post-enzalutamide
57%fatigue
40%Musculoskeletal pain
37%Increased Hemoglobin
23%Hypertension
23%nausea
17%rash
17%Anemia
17%Breast Tenderness
17%hot flashes
17%cough
13%edema
13%gynecomastia
13%pruritis
13%dizziness
13%weight loss
10%headache
10%abdominal pain
10%Creatinine Increased
10%High cholesterol
10%anorexia
10%sinusitis
10%fall
10%constipation
10%eye discorder
7%Syncope
7%chest pain
7%cold symptoms
3%Elevated hematocrit
3%insomnia
3%gallstone
3%Taster change
3%Elevated potassium
3%fever
3%myocardial infarction
3%Acute Renal Insufficiency
3%diarrhea
3%Pancreatitis, elevated lipase, amylase
3%anxiety
3%Elevated liver enzymes
3%Shortness of breath
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT02090114) in the Cohort A:Post-enzalutamide ARM group. Side effects include: fatigue with 57%, Musculoskeletal pain with 40%, Increased Hemoglobin with 37%, Hypertension with 23%, nausea with 23%.

Trial Design

1 Treatment Group

Bipolar Androgen Therapy + Nivolumab
1 of 1

Experimental Treatment

44 Total Participants · 1 Treatment Group

Primary Treatment: Testosterone cypionate · No Placebo Group · Phase 2

Bipolar Androgen Therapy + NivolumabExperimental Group · 2 Interventions: Testosterone cypionate, Nivolumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Testosterone
FDA approved
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,481 Previous Clinical Trials
3,919,545 Total Patients Enrolled
40 Trials studying Prostate Cancer
5,792 Patients Enrolled for Prostate Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
534 Previous Clinical Trials
31,058 Total Patients Enrolled
51 Trials studying Prostate Cancer
2,941 Patients Enrolled for Prostate Cancer
Mark Markowski, MD, Ph.DPrincipal InvestigatorJohns Hopkins University

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Proof of prostate cancer through examination of its cells and tissues.
The definition of serum prostate specific antigen (PSA) progression is two consecutive increases in PSA over a previous reference value, each measurement at least one week apart.
The patient has bone lesions that are documented by the appearance of ≥ 2 new lesions by bone scintigraphy or dimensionally-measureable soft tissue metastatic lesion assessed by CT or MRI.
The absolute PSA level is ≥ 2.0 ng/mL at screening.
Subjects who have received prior treatment with abiraterone, enzalutamide, bicalutamide, and/or ketoconazole are allowed to participate in the study
I am willing and able to provide signed informed consent.
Castrate serum testosterone level: less than or equal to 50 ng/dL.
People who have failed initial hormone therapy, either by having their testicles removed or by taking a gonadotropin-releasing hormone (GnRH) agonist in combination with an anti-androgen, must first progress through anti-androgen withdrawal prior to being eligible
Must have PSA and/or radiographic progression on one or more novel AR targeted therapies (abiraterone acetate, enzalutamide)
People who are 18 years old or older.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 23rd, 2021

Last Reviewed: November 8th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.