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Hormone Therapy
Testosterone + Enzalutamide for Prostate Cancer
Phase 2
Recruiting
Led By Samuel Denmeade, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- PSA progression defined as an increase in PSA, as determined by 2 separate measurements taken at least 1 week apart And/ Or
Histologically-confirmed adenocarcinoma of the prostate
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 3 years
Awards & highlights
No Placebo-Only Group
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
- Metastatic Castration Resistant Prostate Cancer
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical or Radiographic Progression free survival
Secondary outcome measures
Objective Response Rate as Determined by RECIST
Prostate-Specific Antigen Response Rate
Quality of Life as Assessed by FACIT Fatigue Scale
+4 moreSide effects data
From 2017 Phase 3 trial • 92 Patients • NCT0127536518%
Back pain
18%
Upper respiratory tract infection
9%
Diarrhoea
9%
Arthralgia
9%
Dental caries
9%
Muscle spasms
9%
Nasopharyngitis
5%
Cataract operation
5%
Ear discomfort
5%
Palpitations
5%
Gastrooesophageal reflux disease
5%
Oropharyngeal pain
5%
Nocturia
5%
Polyuria
5%
Prostatic asymmetry
5%
Asthma
5%
Polycythaemia
5%
Constipation
5%
Tooth loss
5%
Fatigue
5%
Bronchitis
5%
Contusion
5%
Fall
5%
Laceration
5%
Tendon injury
5%
Biopsy skin
5%
Prostatic specific antigen abnormal
5%
Musculoskeletal stiffness
5%
Myalgia
5%
Pain in extremity
5%
Lower urinary tract symptoms
5%
Urine flow decreased
5%
Ifluenza
5%
Rash macular
5%
Noninfective gingivitis
5%
Inflammation
5%
Oedema peripheral
5%
Muscle strain
5%
Gait disturbance
5%
Nasal congestion
5%
Limb injury
5%
Acne
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo/Low Protein
Placebo/High Protein
Testosterone/Low Protein
Testosterone/High Protein
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm C: Variable Sequential Testosterone and EnzalutamideExperimental Treatment3 Interventions
Patients in Arm C will receive intramuscular injection with testosterone cypionate (T) at a dose of 400 mg every 28 days x 2 injections per cycle. Each cycle is 56 days. Patients with PSA progression will stop T injection and begin Enzalutamide. Patients on T with initial PSA decline will remain on high dose T for additional cycles of 2 injections until PSA progression occurs (≥25% increase in PSA from PSA nadir on current BAT cycle). These patients will then be started on Enzalutamide. Patients with PSA progression will stop Enzalutamide and will restart injections of T with 2 injections/cycle. Patients on enzalutamide with initial PSA decline after one 56-day cycle will continue on Enzalutamide until PSA progression occurs (≥25% increase in PSA from PSA nadir on current Enzalutamide cycle). These cycles of switching between T and Enza with onset of PSA progression will continue until clinical and/or radiographic progression occurs.
Group II: Arm B: Sequential Testosterone and EnzalutamideExperimental Treatment3 Interventions
Patients in Arm B will receive intramuscular injection with testosterone cypionate (T) at a dose of 400 mg every 28 days x 2 (i.e. cycle 1). On Day 1 of cycle 2, patients will stop testosterone and begin enzalutamide 160 mg po q day for 56 days. Each cycle is 56 days. On Day 1 of cycle 3, patient will not take enzalutamide and will again receive injection of testosterone. Patients will continue to alternate one cycle of testosterone (2 injections) with one cycle of 56 days of enzalutamide.
Group III: Arm A: EnzalutamideExperimental Treatment1 Intervention
Patients randomized to Arm A will receive continuous therapy with standard dose Enzalutamide (160 mg oral daily).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Testosterone cypionate
2014
Completed Phase 2
~440
Enzalutamide
2014
Completed Phase 4
~2700
Testosterone enanthate
2014
Completed Phase 3
~190
Find a Location
Who is running the clinical trial?
United States Department of DefenseFED
831 Previous Clinical Trials
220,304 Total Patients Enrolled
37 Trials studying Prostate Cancer
5,252 Patients Enrolled for Prostate Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
549 Previous Clinical Trials
32,670 Total Patients Enrolled
56 Trials studying Prostate Cancer
3,366 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
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your cancer has spread to certain areas that could be dangerous if treated with testosterone. For example, if you have cancer in your bones or liver that could cause fractures or compression of your spinal cord.You have a serious medical, mental, or other condition that could make it unsafe for you to participate in the study or understand what it involves.You have severe pain from prostate cancer that needs to be treated with medication.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm C: Variable Sequential Testosterone and Enzalutamide
- Group 2: Arm B: Sequential Testosterone and Enzalutamide
- Group 3: Arm A: Enzalutamide
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What do medical professionals use testosterone enanthate to help patients with?
"Although typically used to treat multiple sclerosis, Testosterone enanthate can also be helpful in managing leukemia, myelocytic, acute, retinoblastoma, and histiocytic lymphoma."
Answered by AI
Are researchers still working to enroll new participants for this trial?
"That is correct. The trial, which was first posted on 8/19/2020, is still looking for participants. The listing on clinicaltrials.gov was edited on 8/4/2022. They are looking for 150 people total at 1 site."
Answered by AI
Could you tell me if the age limit for participants in this experiment is 35 years or younger?
"To be eligible for this study, potential participants must fall in the age range of 18 to 90. There are 361 other trials for people under the age of 18 and 2029 for people over the age of 65."
Answered by AI
Has the FDA green-lit Testosterone enanthate for public use?
"While Phase 2 trials have not yet gathered data to support efficacy, the safety data that does exist rates Testosterone enanthate at a 2 on our scale."
Answered by AI
What is the maximum amount of people that can take part in this experiment?
"Yes, as of 8/4/2022 this clinical study is recruiting patients. According to the listing on clinicaltrials.gov, the first posting was on 8/19/2020. They are looking for a total of 150 patients from 1 site."
Answered by AI
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