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Hormone Therapy
Sequential 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
Histologically-confirmed adenocarcinoma of the prostate
Treated with continuous androgen ablative therapy (either surgical castration or LHRH agonist/antagonist)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
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.
Who is the study for?
Men over 18 with advanced prostate cancer that's worsened despite hormone therapy and possibly one round of chemotherapy. They must have no prior use of certain other cancer drugs, manageable pain levels, and be off steroids for a period. Major organ functions need to be within acceptable ranges, and they should not have had recent major surgery or serious health conditions that could affect their safety.Check my eligibility
What is being tested?
The trial is testing if giving high doses of testosterone followed by Enzalutamide can slow down the progression of prostate cancer better than just continuous Enzalutamide. Men will be randomly assigned to either the sequential treatment group or the standard therapy group in an open-label setting.See study design
What are the potential side effects?
Potential side effects may include reactions related to testosterone such as increased red blood cell count, sleep apnea symptoms, heart issues, or liver function changes. Enzalutamide might cause fatigue, back pain, constipation, joint discomfort or hot flushes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer was confirmed through a tissue examination.
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I am undergoing hormone therapy for cancer.
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I can take care of myself but might not be able to do heavy physical work.
Select...
My testosterone levels are very low (<50 ng/dl).
Select...
I have not been treated with specific prostate cancer drugs like enzalutamide.
Select...
I am 18 years old or older.
Select...
My cancer progressed despite treatment with abiraterone and hormone therapy.
Timeline
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%
Pain in extremity
5%
Cataract operation
5%
Ifluenza
5%
Musculoskeletal stiffness
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%
Myalgia
5%
Lower urinary tract symptoms
5%
Urine flow decreased
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
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 enanthate
2014
Completed Phase 3
~190
Enzalutamide
2014
Completed Phase 4
~2760
Testosterone cypionate
2014
Completed Phase 2
~440
Find a Location
Who is running the clinical trial?
United States Department of DefenseFED
865 Previous Clinical Trials
327,549 Total Patients Enrolled
39 Trials studying Prostate Cancer
9,204 Patients Enrolled for Prostate Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
560 Previous Clinical Trials
32,899 Total Patients Enrolled
58 Trials studying Prostate Cancer
3,428 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:- My prostate cancer was confirmed through a tissue examination.I am undergoing hormone therapy for cancer.I stopped taking abiraterone more than 2 weeks ago.I use a catheter for urination due to prostate issues.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.My kidney function is within normal ranges.I haven't had major surgery in the last 3 weeks or still recovering from one.My cancer's location or extent makes testosterone therapy risky for me.I need pain medication for my prostate cancer that has spread.I am not on warfarin, rivaroxaban, or apixaban, or I can switch to enoxaparin.I have previously been treated with testosterone.I have not received docetaxel or cabazitaxel for prostate cancer.I can take care of myself but might not be able to do heavy physical work.My testosterone levels are very low (<50 ng/dl).I had Provenge vaccine and Xofigo more than 4 weeks ago.I do not have an active, uncontrolled infection or a known history of HIV/AIDS or hepatitis B or C.I have not been treated with specific prostate cancer drugs like enzalutamide.I don't have severe sleep apnea, uncontrolled heart failure, or a high hematocrit level.I am 18 years old or older.My liver is functioning well.My cancer progressed despite treatment with abiraterone and hormone therapy.I am mentally able to participate and follow the study's requirements.I have tried to stop taking prednisone or am on the lowest dose possible.I need help with my daily activities due to my health condition.I have never been treated with enzalutamide.I have not had a blood clot in the past year or am on blood thinners if I did.I have had one chemotherapy treatment with docetaxel for prostate cancer.I agree to have two biopsies for my soft tissue lesion, one before and one during treatment.It has been over 4 weeks since my last radiation or chemotherapy session.
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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