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Hormone Therapy
Hormone Therapy + Medications for Prostate Cancer
Phase 2
Waitlist Available
Led By Howard Scher, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Primary tumor considered unresectable by RP based on initial imaging
Able to swallow the study drug(s) whole as a tablet
Must not have
History of inflammatory bowel disease
Baseline moderate and severe hepatic impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if treatment with medications that reduce the male hormone level can shrink prostate cancer and reduce the chances of the cancer coming back. The treatments include a hormone injection and the study drugs, which include abiraterone acetate, prednisone, and apalutamide.
Who is the study for?
Men over 18 with advanced prostate cancer, who can consent and have adequate organ function. They must not have other active cancers or major health issues that could interfere with the trial, no prior treatments for prostate cancer (with some exceptions), and agree to use effective contraception.
What is being tested?
The study tests if hormone reduction drugs before surgery can shrink prostate cancer effectively. It combines monthly hormone injections, abiraterone acetate, prednisone, apalutamide with surgery and possibly radiotherapy to see if this approach is more successful in eliminating cancer.
What are the potential side effects?
Possible side effects include hormonal changes leading to hot flashes or sexual dysfunction, fatigue from anemia due to bone marrow suppression, liver function alterations from medication toxicity, potential digestive disturbances from pills taken orally.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My primary tumor cannot be surgically removed.
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I can swallow pills without any difficulty.
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My prostate cancer has a Gleason score of 7 and an Oncotype score over 40.
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I am a man aged 18 or older.
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My prostate cancer is aggressive, based on Gleason score and tumor size.
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My cancer has recently spread but only to a few places.
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My prostate cancer came back after surgery, as shown on a PSMA PET scan.
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I am fully active and can carry on all my pre-disease activities without restriction.
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I am willing to take abiraterone acetate without eating.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of inflammatory bowel disease.
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My liver is not working well.
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I have been treated with medications targeting the AR signaling pathway.
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My cancer has spread to my brain, liver, lungs, or other internal organs.
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I have had treatments targeting the spread of my prostate cancer.
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I have had issues with my pituitary or adrenal glands.
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I have a serious heart condition.
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I have another active cancer or was diagnosed with cancer in the last 2 years.
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I need to take more than 10 mg of prednisone or prednisolone daily for a chronic condition.
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I have received chemotherapy or biological therapy for prostate cancer.
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I have a history of seizures or conditions that could lead to seizures.
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My diabetes is not well-controlled.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Minimal residual disease (MRD)
Pathologic complete response
Secondary study objectives
PSA Response Rate
Time to PSA Progression
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: Apalutamide, SBRT, RadiationExperimental Treatment2 Interventions
Group II: ADT + Apalutamide + Abiraterone Acetate + PrednisoneExperimental Treatment6 Interventions
This arm is no longer being assigned to subjects.
Group III: ADT + ApalutamideExperimental Treatment4 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~790
Radical Prostatectomy
2005
Completed Phase 2
~4550
Prednisone
2014
Completed Phase 4
~2500
Apalutamide
2015
Completed Phase 2
~5660
Abiraterone Acetate
2015
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,965 Previous Clinical Trials
596,918 Total Patients Enrolled
133 Trials studying Prostate Cancer
51,521 Patients Enrolled for Prostate Cancer
Dana-Farber Cancer InstituteOTHER
1,107 Previous Clinical Trials
357,026 Total Patients Enrolled
76 Trials studying Prostate Cancer
15,610 Patients Enrolled for Prostate Cancer
Howard Scher, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
36 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver, kidneys, and bone marrow are functioning well.My primary tumor cannot be surgically removed.I can swallow pills without any difficulty.My prostate cancer has a Gleason score of 7 and an Oncotype score over 40.I have had treatment for prostate cancer but may still qualify for a specific study group.I have been on hormone therapy for prostate cancer for up to 2 months.I have a history of inflammatory bowel disease.My liver is not working well.My cancer's stage was confirmed within the last 3 months.My metastases have been confirmed by a biopsy, if it was safe and possible.I have had issues with my pituitary or adrenal glands.I am a man aged 18 or older.My prostate cancer is confirmed by a biopsy.My prostate cancer is aggressive, based on Gleason score and tumor size.I haven't taken any forbidden medications in the last 14 days.I have been treated with medications targeting the AR signaling pathway.My cancer has spread to my brain, liver, lungs, or other internal organs.I have had treatments targeting the spread of my prostate cancer.I have a serious heart condition.My testosterone level is at least 150 ng/dL or I'm on ADT for my treatment.My cancer has recently spread but only to a few places.My prostate cancer came back after surgery, as shown on a PSMA PET scan.I am fully active and can carry on all my pre-disease activities without restriction.I have another active cancer or was diagnosed with cancer in the last 2 years.I am willing to take abiraterone acetate without eating.I need to take more than 10 mg of prednisone or prednisolone daily for a chronic condition.I have received chemotherapy or biological therapy for prostate cancer.I have recovered from my last surgery and it's been at least 4 weeks since.I have a history of seizures or conditions that could lead to seizures.My diabetes is not well-controlled.
Research Study Groups:
This trial has the following groups:- Group 1: Apalutamide, SBRT, Radiation
- Group 2: ADT + Apalutamide + Abiraterone Acetate + Prednisone
- Group 3: ADT + Apalutamide
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.
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