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Antiandrogen
Apalutamide Before Surgery for Prostate Cancer
Phase 2
Waitlist Available
Led By John W Davis
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Normal coagulation profile and no history of substantial non-iatrogenic bleeding diathesis
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 to 5 years
Awards & highlights
Study Summary
This trial looks at how effective apalutamide is in treating prostate cancer before surgery. It may work by lowering androgen levels, which could make radiation therapy after surgery unnecessary.
Who is the study for?
Men with intermediate-risk prostate cancer, suitable for surgery, and no metastases. They must have a testosterone level above 200 ng/mL, agree to use contraception during the trial and for 3 months after, be able to swallow tablets, and not have other serious health issues or another active malignancy.Check my eligibility
What is being tested?
The trial is testing apalutamide's effectiveness in treating prostate cancer before surgical removal of the prostate. Apalutamide is a hormone therapy that lowers androgen levels which may reduce the need for radiation post-surgery.See study design
What are the potential side effects?
Apalutamide can cause fatigue, high blood pressure, skin rash, falls or fractures due to bone weakness; digestive issues like diarrhea; weight loss; joint pain; hot flushes; swelling in limbs; headache.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood clotting is normal and I don't have a history of unusual bleeding.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My kidney function is good.
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My prostate cancer diagnosis was confirmed through a tissue examination.
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My cancer is extensive enough for a major lymph node surgery, as agreed by a surgeon.
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I can swallow pills without any difficulty.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Aggregate Pathologic Risk Features
Secondary outcome measures
Adverse Events (AE_) of Neoadjuvant Apalutamide Followed by Radical Prostatectomy
Biochemical Recurrence Rate
Estimation of the frequency of clinical complete responses (pT0) and "near" complete responses (<6mm total tumor volume)
+2 moreSide effects data
From 2021 Phase 2 trial • 86 Patients • NCT0327925074%
Hot flashes
71%
Fatigue
44%
Anemia
38%
Hyperglycemia
26%
AST increase
26%
Hypertension
26%
Lipase increase
24%
ALT increase
24%
Dry skin
21%
Rash
18%
ACTH increase
18%
Cholesterol high
15%
Amylase increase
15%
Dizziness
12%
Memory impairment
12%
White blood cell decrease
12%
Constipation
12%
Lymphocyte count decrease
9%
Myalgia
9%
Paresthesia
9%
Weight loss
9%
Arthralgia
9%
Hypothyrodism
9%
LDH increase
6%
Personality change
6%
Erectile dysfunction
6%
Headache
6%
Dysgeusia
6%
Dyspnea
6%
HbA1c increased
6%
Hypertriglyceridemia
6%
Insomnia
6%
Irritability
3%
Anxiety
3%
Atrial fibrillation
3%
Bruising
3%
Anorexia
3%
Hypercalcemia
3%
Dehydration
3%
TSH increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (LHRHa, Apalutamide, Abiraterone Acetate)
Arm A (LHRHa, Apalutamide)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (apalutamide, radical prostatectomy)Experimental Treatment3 Interventions
Patients receive apalutamide PO daily for 24 weeks in the absence of disease progression or unacceptable toxicity. Within 2 weeks of completing apalutamide, patients undergo radical prostatectomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radical Prostatectomy
2005
Completed Phase 2
~4550
Apalutamide
2015
Completed Phase 2
~3310
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,731 Total Patients Enrolled
96 Trials studying Prostate Cancer
29,740 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,103 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,173 Patients Enrolled for Prostate Cancer
John W DavisPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had serious heart issues like a heart attack or severe heart failure recently.My scans show no signs of cancer spread, and any suspicious lymph nodes are smaller than 10 mm.My high blood pressure is under control with medication.My PSA level is over 20 ng/mL, but my doctor thinks it's due to non-cancer reasons.I have had at least 10 prostate biopsies and meet the specific risk criteria for prostate cancer.My blood clotting is normal and I don't have a history of unusual bleeding.I have stomach or intestine problems that could affect how I absorb medication.I am not a candidate for prostate surgery due to other serious health issues.I do not have an active cancer other than non-melanoma skin cancer or one likely to return within a year.I have a history of seizures or conditions that could lead to seizures.My cancer is not adenocarcinoma but another type like neuroendocrine, small cell, or sarcomatoid.I have active hepatitis or chronic liver disease.I have had hormone therapy for prostate cancer.I am fully active or restricted in physically strenuous activity but can do light work.My urologist and I agree that I am a good candidate for prostate surgery.My kidney function is good.My prostate cancer diagnosis was confirmed through a tissue examination.I do not have any serious illnesses or infections that are not under control.My cancer is extensive enough for a major lymph node surgery, as agreed by a surgeon.I can swallow pills without any difficulty.I have a history of pituitary or adrenal disease.
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: Treatment (apalutamide, radical prostatectomy)
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have any other investigations been conducted in regards to Apalutamide?
"At present, 44 research initiatives are examining Apalutamide with 15 of those trials in their third phase. 2417 medical centres around the world have launched studies on this drug, although most experiments take place at South Weymouth in Massachusetts."
Answered by AI
Is this a hitherto unseen experiment?
"Research into Apalutamide began in 2014 under the sponsorship of Aragon Pharmaceuticals, Inc.. After a successful Phase 3 trial involving 982 patients that same year, 44 current studies are being held across 552 cities and 38 countries."
Answered by AI
Has Apalutamide been granted regulatory authorization by the FDA?
"Apalutamide is considered relatively safe, with a rating of 2 on the 1 to 3 scale due to being in Phase 2 clinical trials. At this stage, there are data confirming safety but none yet offering proof of efficacy."
Answered by AI
To what extent is this clinical trial reaching out to those in need of treatment?
"At the present moment, this particular study is not recruiting. It was initially posted on March 22nd 2018 and most recently edited October 20th 2022. If you're scouting for alternative trials, 1270 studies are presently searching for participants with prostate cancer while 44 different clinical trials are accepting patients taking Apalutamide."
Answered by AI
Is enrollment for this experiment still open?
"This trial is currently not recruiting any more participants; the original posting was on March 22nd 2018, and it hadn't been updated since October 20th 2022. There are 1270 trials that involve prostate cancer patients who need recruits, as well as 44 studies looking for individuals eligible to take Apalutamide."
Answered by AI
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