Testosterone enanthate for Prostate Cancer

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

Study Summary

This trial is testing a new treatment for men with prostate cancer that has progressed even after other treatments. The new treatment is a combination of high dose testosterone and Enzalutamide, and the goal is to see if it is better than the standard treatment (just Enzalutamide) at improving the primary and secondary objectives.

Eligible Conditions
  • Prostate Cancer
  • Castration

Treatment Effectiveness

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Up to 3 years

Up to 1 year
Quality of Life as Assessed by FACIT Fatigue Scale
Quality of Life as Assessed by Short Form 36
Up to 2 years
Clinical or Radiographic Progression free survival
Objective Response Rate as Determined by RECIST
Prostate-Specific Antigen Response Rate
Radiographic Progression free survival
Safety of cyclical parenteral testosterone as assessed by the revised National Cancer Institute Common Toxicity Criteria
Up to 3 years
Time to Overall Survival

Trial Safety

Safety Progress

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

Side Effects for

Testosterone/Low Protein
18%Back pain
18%Upper respiratory tract infection
9%Nasopharyngitis
9%Dental caries
9%Diarrhoea
9%Muscle spasms
9%Arthralgia
5%Fall
5%Polycythaemia
5%Musculoskeletal stiffness
5%Tendon injury
5%Fatigue
5%Palpitations
5%Urine flow decreased
5%Polyuria
5%Ifluenza
5%Gait disturbance
5%Nasal congestion
5%Asthma
5%Muscle strain
5%Rash macular
5%Myalgia
5%Acne
5%Prostatic specific antigen abnormal
5%Ear discomfort
5%Gastrooesophageal reflux disease
5%Tooth loss
5%Oropharyngeal pain
5%Constipation
5%Contusion
5%Inflammation
5%Noninfective gingivitis
5%Laceration
5%Limb injury
5%Bronchitis
5%Biopsy skin
5%Lower urinary tract symptoms
5%Oedema peripheral
5%Pain in extremity
5%Nocturia
5%Prostatic asymmetry
5%Cataract operation
This histogram enumerates side effects from a completed 2017 Phase 3 trial (NCT01275365) in the Testosterone/Low Protein ARM group. Side effects include: Back pain with 18%, Upper respiratory tract infection with 18%, Nasopharyngitis with 9%, Dental caries with 9%, Diarrhoea with 9%.

Trial Design

3 Treatment Groups

Arm C: Variable Sequential Testosterone and Enzalutamide
1 of 3
Arm B: Sequential Testosterone and Enzalutamide
1 of 3
Arm A: Enzalutamide
1 of 3

Experimental Treatment

150 Total Participants · 3 Treatment Groups

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

Arm C: Variable Sequential Testosterone and EnzalutamideExperimental Group · 3 Interventions: Testosterone cypionate, Enzalutamide, Testosterone enanthate · Intervention Types: Drug, Drug, Drug
Arm B: Sequential Testosterone and EnzalutamideExperimental Group · 3 Interventions: Testosterone cypionate, Enzalutamide, Testosterone enanthate · Intervention Types: Drug, Drug, Drug
Arm A: Enzalutamide
Drug
Experimental Group · 1 Intervention: Enzalutamide · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Testosterone cypionate
FDA approved
Cyclophosphamide
FDA approved
Testosterone enanthate
FDA approved

Trial Logistics

Trial Timeline

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

Who is running the clinical trial?

United States Department of DefenseFED
767 Previous Clinical Trials
202,101 Total Patients Enrolled
35 Trials studying Prostate Cancer
5,051 Patients Enrolled for Prostate Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
534 Previous Clinical Trials
30,952 Total Patients Enrolled
52 Trials studying Prostate Cancer
2,985 Patients Enrolled for Prostate Cancer
Samuel Denmeade, MDPrincipal InvestigatorSKCCC at Johns Hopkins
7 Previous Clinical Trials
423 Total Patients Enrolled
5 Trials studying Prostate Cancer
168 Patients Enrolled for Prostate Cancer

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have histologically-confirmed adenocarcinoma of the prostate.
You have a documented castrate level of serum testosterone (<50 ng/dl).
You have metastatic disease radiographically documented by CT or bone scan.
You have been diagnosed with prostate cancer, and have a PSA level of ≥ 1.0 ng/mL.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 21st, 2021

Last Reviewed: November 11th, 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.