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Hormone Therapy
Prostatectomy for Prostate Cancer
Phase 2
Recruiting
Led By Isaac Kim
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prostate deemed resectable by surgeon
Hemoglobin (HgB) >= 9 g/dL compatible for surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, a minimum of 4 years
Awards & highlights
Study Summary
This trial is studying how well surgery, antiandrogen therapy, and/or docetaxel work in treating men with newly diagnosed prostate cancer that has spread to other places in the body.
Who is the study for?
Men with newly diagnosed metastatic prostate cancer who have started or plan to start antiandrogen therapy within the last 6 months. They must not have had previous local treatments for prostate cancer, should be able to undergo surgery, and have a life expectancy of more than 6 months. Their blood counts and liver enzymes need to be at certain levels, and they must be physically well enough (ECOG status of 0 or 1).Check my eligibility
What is being tested?
The trial is testing if removing the prostate gland surgically combined with hormone-blocking therapy works better with or without docetaxel chemotherapy in men whose prostate cancer has spread. The study will compare how these different treatments affect tumor growth by killing cells, stopping cell division, or preventing spread.See study design
What are the potential side effects?
Surgery can lead to pain, bleeding, infection risk and urinary issues. Antiandrogen therapy might cause hot flashes, sexual dysfunction and bone thinning. Docetaxel may result in hair loss, nausea/vomiting, fatigue and increased risk of infections due to low blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My surgeon has determined my prostate can be surgically removed.
Select...
My hemoglobin level is at least 9 g/dL, making me fit for surgery.
Select...
My cancer has spread, confirmed by scans or tests.
Select...
My cancer has spread to distant lymph nodes, bones, or other organs.
Select...
My platelet count is above 80,000, suitable for surgery.
Select...
My liver enzyme ALT levels are within twice the normal limit.
Select...
My prostate cancer was confirmed through a tissue examination.
Select...
I have not had any local treatments for prostate cancer.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My liver enzyme AST levels are within twice the normal limit.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, a minimum of 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, a minimum of 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Failure-free survival (FFS)
Secondary outcome measures
Cancer-specific survival
Overall complication rate
Overall survival
+1 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
2Treatment groups
Experimental Treatment
Group I: Arm II (ADT, radical prostatectomy, docetaxel)Experimental Treatment6 Interventions
Participants receive antiandrogen therapy for at least 1 month, then undergo cytoreductive radical prostatectomy. Participants continue antiandrogen therapy and may receive docetaxel prior to surgery at the discretion of the treating physician.
Group II: Arm I (ADT, docetaxel)Experimental Treatment5 Interventions
Participants receive antiandrogen therapy with or without docetaxel at the discretion of the treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radical Prostatectomy
2005
Completed Phase 2
~4550
Quality-of-Life Assessment
2017
Completed Phase 3
~4950
Antiandrogen Therapy
2015
Completed Phase 1
~10
Docetaxel
1995
Completed Phase 4
~5620
Find a Location
Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,042 Total Patients Enrolled
14 Trials studying Prostate Cancer
1,044 Patients Enrolled for Prostate Cancer
Yale UniversityLead Sponsor
1,851 Previous Clinical Trials
2,738,023 Total Patients Enrolled
6 Trials studying Prostate Cancer
892 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,925,883 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,095 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My single cancer spread was confirmed by biopsy or two different scans.My surgeon has determined my prostate can be surgically removed.Your doctor believes that you have less than 6 months to live.I started hormone therapy for cancer less than 6 months ago.My hemoglobin level is at least 9 g/dL, making me fit for surgery.My surgeon says my cancer cannot be removed by surgery.I have had a blood clot in my leg or lung in the last 6 months.My cancer has spread, confirmed by scans or tests.My cancer has spread to distant lymph nodes, bones, or other organs.My platelet count is above 80,000, suitable for surgery.I have pressure on my spinal cord.I have been on hormone therapy for prostate cancer for over 6 months.My liver enzyme ALT levels are within twice the normal limit.I haven't had chemotherapy or radiotherapy for conditions other than prostate cancer in the last 3 weeks.My prostate cancer was confirmed through a tissue examination.I have had treatment directly on my prostate before.I have not had any local treatments for prostate cancer.I am fully active or restricted in physically strenuous activity but can do light work.My liver enzyme AST levels are within twice the normal limit.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (ADT, radical prostatectomy, docetaxel)
- Group 2: Arm I (ADT, docetaxel)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there various medical facilities conducting this research study in the city?
"Currently, 8 medical centres are running this clinical trial. Locations include New Haven, New Brunswick and Seattle along with 5 other cities. To reduce travel obligations, potential participants should select the closest clinic to their residence."
Answered by AI
Are there any opportunities for patients to participate in this experiment at present?
"This study is currently seeking participants, as indicated by clinicaltrials.gov. It was first posted on March 14th 2018 and last updated on September 22nd 2022."
Answered by AI
What health issues is Radical Prostatectomy typically utilized to address?
"Radical Prostatectomy is widely utilized to address malignant neoplasms, yet it may also be administered for advanced directives, sarcoma and esophageal cancers."
Answered by AI
Can you provide a synopsis of the previous research done on Radical Prostatectomy?
"Presently, there are 320 active Radical Prostatectomy trials being conducted worldwide. Of those, 126 have progressed to the third phase of clinical testing. While Fuzhou, Fujian is home to many of these studies, 22389 other locations across the globe offer this treatment."
Answered by AI
How many research subjects are participating in this experiment?
"This medical trial requires 190 volunteers, who meet the eligibility requirements, to partake in its study. Potential participants can register at Yale University in New Haven, Connecticut or Rutgers Cancer Institute of New jersey located in New Brunswick."
Answered by AI
To what degree could Radical Prostatectomy be detrimental to those receiving the procedure?
"Considering the lack of efficacy data, Radical Prostatectomy was rated a 2 on our scale. Nevertheless, there is prior evidence proving its safety in Phase 2 trials."
Answered by AI
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