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Hormone Therapy
Testosterone cypionate for Prostate Cancer (Restore Trial)
Phase 2
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Restore Trial Summary
This trial is testing whether giving testosterone then enzalutamide, abiraterone, or castration-only therapy to men with metastatic CRPC who have progressed on one of these forms of therapy, will be effective. There will be four groups of patients, each with a different previous treatment.
Eligible Conditions
- Prostate Cancer
Restore Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PSA Response to Enzalutamide or Abiraterone Acetate Post Bipolar Androgen Therapy
Prostate Specific Antigen (PSA) Response to Bipolar Androgen Therapy (BAT)
Secondary outcome measures
Disease Response as Defined by RECIST 1.1 (Soft Tissue Lesions) and PCWG2 Criteria (Bone Lesions)
Initiation of Docetaxel Chemotherapy
PSA Progression on BAT (Bipolar Androgen Therapy )
+7 moreSide effects data
From 2021 Phase 2 trial • 112 Patients • NCT0209011457%
fatigue
40%
Musculoskeletal pain
37%
Increased Hemoglobin
23%
Hypertension
23%
nausea
17%
Anemia
17%
Breast Tenderness
17%
rash
17%
hot flashes
17%
cough
13%
weight loss
13%
gynecomastia
13%
pruritis
13%
edema
13%
dizziness
10%
constipation
10%
Creatinine Increased
10%
anorexia
10%
abdominal pain
10%
fall
10%
sinusitis
10%
headache
10%
High cholesterol
10%
eye discorder
7%
Syncope
7%
chest pain
7%
cold symptoms
3%
diarrhea
3%
myocardial infarction
3%
insomnia
3%
Acute Renal Insufficiency
3%
anxiety
3%
Elevated liver enzymes
3%
Elevated hematocrit
3%
Pancreatitis, elevated lipase, amylase
3%
gallstone
3%
fever
3%
Taster change
3%
Elevated potassium
3%
Shortness of breath
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A:Post-enzalutamide
Cohort B: Post-abiraterone
Cohort C: Castration Only
Cohort D: Mutation
Restore Trial Design
4Treatment groups
Experimental Treatment
Group I: Cohort D: MutationExperimental Treatment2 Interventions
Men with metastatic prostate cancer who have castrate resistant prostate cancer with inactivating somatic or germline mutations in the genes TP53, RB1 or PTEN identified using clinical grade sequencing of tumor tissue performed by qualified laboratory. Patients must have mutations in ≥2 of these genes to be eligible. Eligible patients must have progressed on first line hormone therapy with LHRH agonist alone and must have received at least one but not more than two second generation androgen ablative therapy (i.e. Abiraterone, Enzalutamide or Apalutamide).
Group II: Cohort C: Castration OnlyExperimental Treatment2 Interventions
Men with metastatic prostate cancer who have only received first line hormone therapy with LHRH agonist alone or LHRH agonist plus an anti-androgen. Patients who have developed castrate resistance to first line therapy and have then received second line hormone therapy of any kind (including flutamide, bicalutamide, nilutamide, ketoconazole, abiraterone, enzalutamide, ARN-509 and investigational anti-androgens) are not eligible for enrollment in this cohort.
Group III: Cohort B: Post-abirateroneExperimental Treatment3 Interventions
Men with castration-resistant prostate cancer who have progressed on abiraterone will be enrolled to this cohort. These patients will then receive intramuscular injections with testosterone cypionate 400 mg every 28 days or testosterone enanthate 400 mg every 28 days. Upon progression on testosterone cypionate or enanthate, men will be retreated with abiraterone 1000 mg by mouth daily.
Group IV: Cohort A:Post-enzalutamideExperimental Treatment3 Interventions
Men with castration-resistant prostate cancer who have progressed on enzalutamide will be enrolled to this cohort. These patients will then receive intramuscular injections with testosterone cypionate 400 mg every 28 days or testosterone enanthate 400 mg every 28 days. Upon progression on testosterone cypionate or enanthate, men will be retreated with enzalutamide 160 mg by mouth daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abiraterone acetate
2014
Completed Phase 3
~3440
Enzalutamide
2014
Completed Phase 4
~2760
Testosterone Enanthate
2002
Completed Phase 4
~670
Testosterone cypionate
2014
Completed Phase 2
~440
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,808 Total Patients Enrolled
56 Trials studying Prostate Cancer
3,236 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,742 Total Patients Enrolled
560 Trials studying Prostate Cancer
506,983 Patients Enrolled for Prostate Cancer
Samuel Denmeade, MDPrincipal InvestigatorJohns Hopkins School of Medicine - Sidney Kimmel Comprehensive Cancer Center
7 Previous Clinical Trials
461 Total Patients Enrolled
4 Trials studying Prostate Cancer
56 Patients Enrolled for Prostate Cancer
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