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Hormone Therapy

Standard Therapy + Surgery/Radiation for Prostate Cancer

Phase 3
Recruiting
Led By Brian Chapin
Research Sponsored by SWOG Cancer Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate. Patients with pure small cell carcinoma* (SCC), sarcomatoid, or squamous cell carcinoma are not eligible. (*morphology must be consistent with SCC; synaptophysin or chromogranin positive by immunohistochemical staining is insufficient to diagnose SCC).
STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have an intact prostate. No prior local therapy for prostate adenocarcinoma is allowed (e.g., brachytherapy, high-intensity focused ultrasound [HIFU], cryotherapy, laser ablative therapies). Any prior therapy for benign conditions, such as obstruction, are acceptable (e.g., transurethral resection of the prostate, greenlight laser ablation, microwave ablation).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Study Summary

This trial is testing whether adding surgery or radiation therapy to standard treatment for prostate cancer that has spread to other parts of the body lowers the chance of the cancer growing or spreading.

Who is the study for?
Men with metastatic prostate cancer who've had less than 28 weeks of standard therapy without disease progression are eligible. They must have a low testosterone level, no brain metastases, and an intact prostate with no prior local treatment for cancer. Prior treatments for benign conditions are okay. Participants should be able to complete quality-of-life assessments in English, Spanish or French.Check my eligibility
What is being tested?
This phase III trial is testing if adding surgery (prostate removal) or radiation to the usual systemic therapy improves outcomes in men whose prostate cancer has spread. The study will compare the effects of these combined treatments on the growth and spread of cancer.See study design
What are the potential side effects?
Potential side effects include those from standard systemic therapies like hormone shots and chemotherapy drugs: fatigue, nausea, pain at injection sites, hormonal imbalances leading to mood swings or hot flashes, and possible increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with prostate adenocarcinoma, not small cell or squamous cell carcinoma.
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My prostate is intact and I haven't had any treatment for prostate cancer.
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My scans show cancer has spread and I've had these tests within the last 42 days.
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I do not have brain metastases and show no signs of brain-related symptoms.
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I have had less than 28 weeks of standard treatment for metastatic prostate cancer.
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My condition did not worsen while on hormone therapy.
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I have been diagnosed with prostate adenocarcinoma, not small cell or squamous cell carcinoma.
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My prostate is intact and I haven't had any treatment for prostate cancer.
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My scans show cancer has spread and I've had these tests within the last 42 days.
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I do not have brain metastases.
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I have had less than 28 weeks of standard treatment for metastatic prostate cancer.
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I have not worsened while on hormone therapy for my cancer.
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I have prostate cancer with up to four treated metastases.
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I have no cancer history except for certain treated cancers or any from which I've been disease-free for 3 years.
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I can complete health surveys in English, Spanish, or French.
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My cancer has not worsened in the last 28 weeks according to tests and I haven't felt worse.
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I have seen a urologist and my disease can be surgically removed.
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I have been on hormone therapy for prostate cancer for 22 to 28 weeks.
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I am not planning to receive docetaxel treatment after being assigned to a study group.
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Any side effects from my previous treatment have mostly gone away.
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I have had treatment for up to 4 cancer spread sites before joining this study.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My prostate cancer is confirmed by lab tests but not small cell, sarcomatoid, or squamous type.
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I have had less than 28 weeks of standard treatment for metastatic prostate cancer.
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My condition did not worsen while on hormone therapy.
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I have seen a urologist and my condition can be treated with surgery.
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I am not planning to receive docetaxel treatment after being assigned to a study group.
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My testosterone level is below 50 ng/dL.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival (OS)
Secondary outcome measures
Media OS
Progression-free survival (PFS)
Rate of symptomatic local progression

Side effects data

From 2022 Phase 3 trial • 87 Patients • NCT02066181
73%
Fatigue
71%
Palmar-plantar erythrodysesthesia syndrome
63%
Hypertension
61%
Papulopustular rash
55%
Diarrhea
51%
Nausea
39%
Myalgia
37%
Alopecia
35%
Arthralgia
33%
Abdominal pain
31%
Anorexia
27%
Vomiting
22%
Mucositis oral
22%
Constipation
18%
Anemia
18%
Alanine aminotransferase increased
16%
Platelet count decreased
14%
Pruritus
14%
Hyperglycemia
14%
Rash maculo-papular
14%
Skin and subcutaneous tissue disorders - Other, specify
12%
Aspartate aminotransferase increased
12%
Rash acneiform
12%
Peripheral sensory neuropathy
10%
Investigations - Other, specify
10%
Dry skin
10%
Neutrophil count decreased
10%
Blood bilirubin increased
8%
Back pain
8%
Headache
8%
Nervous system disorders - Other, specify
8%
Pain in extremity
6%
General disorders and administration site conditions - Other, specify
6%
Skin infection
6%
White blood cell decreased
6%
Hypercalcemia
6%
Hypokalemia
6%
Musculoskeletal and connective tissue disorder - Other, specify
6%
Dizziness
6%
Respiratory, thoracic and mediastinal disorders - Other, specify
6%
Eye disorders - Other, specify
6%
Hyperkalemia
6%
Pain
6%
Alkaline phosphatase increased
6%
Hypocalcemia
6%
Cough
4%
Flushing
4%
Tinnitus
4%
Dental caries
4%
Gastrointestinal disorders - Other, specify
4%
Hemoglobin increased
4%
Weight loss
4%
Metabolism and nutrition disorders - Other, specify
4%
Dysgeusia
4%
Anxiety
4%
Irregular menstruation
4%
Menorrhagia
4%
Sore throat
4%
Lymphocyte count decreased
4%
Hyperuricemia
4%
Non-cardiac chest pain
4%
Infections and infestations - Other, specify
4%
Hypernatremia
4%
Hypoglycemia
4%
Scalp pain
4%
Dry mouth
2%
Hypothyroidism
2%
Hemorrhoids
2%
Blurred vision
2%
Palpitations
2%
Acute kidney injury
2%
Leukocytosis
2%
Myocardial infarction
2%
Vertigo
2%
Anal hemorrhage
2%
Dysphagia
2%
Esophageal pain
2%
Periodontal disease
2%
Fever
2%
Sinusitis
2%
Urinary tract infection
2%
Bruising
2%
Dermatitis radiation
2%
Cholesterol high
2%
Creatinine increased
2%
Neck pain
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Concentration impairment
2%
Memory impairment
2%
Spasticity
2%
Depression
2%
Insomnia
2%
Allergic rhinitis
2%
Productive cough
2%
Sleep apnea
2%
Pregnancy, puerperium and perinatal conditions - Other, specify
2%
Dry eye
2%
Lymphedema
2%
Chest pain - cardiac
2%
Heart failure
2%
Gastric perforation
2%
Hypertriglyceridemia
2%
Dyspnea
2%
Cardiac disorders - Other, specify
2%
Gastroesophageal reflux disease
2%
Oral dysesthesia
2%
Chills
2%
Hypophosphatemia
2%
Chest wall pain
2%
Psychiatric disorders - Other, specify
2%
Hematuria
2%
Urinary tract obstruction
2%
Dysmenorrhea
2%
Skin hypopigmentation
2%
Urticaria
2%
Unintended pregnancy
2%
Flu like symptoms
2%
Nail infection
2%
Pancreatitis
2%
Blood and lymphatic system disorders - Other, specify
2%
Oral pain
2%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Sorafenib Tosylate)
Arm II (Placebo)
Crossover Group

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (SST, prostatectomy or radiation therapy)Experimental Treatment13 Interventions
Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone. Participants undergo prostatectomy within 8 weeks after randomization or radiation therapy within 4 weeks of randomization.
Group II: Arm I (SST)Active Control11 Interventions
Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone.
Group III: Step 1 (pre-randomization)Active Control13 Interventions
Standard treatment data collection prior to randomization
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Triptorelin
2017
Completed Phase 4
~1370
Radiation Therapy
2017
Completed Phase 3
~7250
Radical Prostatectomy
2005
Completed Phase 2
~4550
Abiraterone
2012
Completed Phase 4
~2830
Bicalutamide
2003
Completed Phase 3
~5330
Degarelix
2002
Completed Phase 3
~3600
Flutamide
2013
Completed Phase 4
~1920
Goserelin Acetate
2007
Completed Phase 3
~1040
Leuprolide Acetate
2002
Completed Phase 3
~1890
Nilutamide
1996
Completed Phase 3
~310
Orchiectomy
2010
Completed Phase 4
~50

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
264,337 Total Patients Enrolled
27 Trials studying Prostate Cancer
53,550 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,587 Previous Clinical Trials
41,241,229 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,279 Patients Enrolled for Prostate Cancer
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
260,978 Total Patients Enrolled
27 Trials studying Prostate Cancer
53,550 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03678025 — Phase 3
Prostate Cancer Research Study Groups: Arm I (SST), Arm II (SST, prostatectomy or radiation therapy), Step 1 (pre-randomization)
Prostate Cancer Clinical Trial 2023: Abiraterone Highlights & Side Effects. Trial Name: NCT03678025 — Phase 3
Abiraterone (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03678025 — Phase 3
Prostate Cancer Patient Testimony for trial: Trial Name: NCT03678025 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you please share prior research on Quality-of-Life Assessment?

"Quality-of-Life Assessment was first researched in 1995 at National Institutes of Health Clinical Center. In the years since, there have been nearly 3000 completed clinical trials on the topic. As of now, 1002 clinical trials are still active and recruiting patients. A high concentration of these active trials are based in Troy, Michigan."

Answered by AI

Is Quality-of-Life Assessment a health risk for people?

"There is some data to support the efficacy of Quality-of-Life Assessment, and it has received multiple rounds of data supporting its safety, so it is estimated to be a 3 on a scale from 1 to 3."

Answered by AI

Where are patients able to enroll in this trial?

"This study has 21st Century Oncology MHP - Troy in Troy, Michigan, University of Chicago Comprehensive Cancer Center in Chicago, Missouri, and OSF Saint Francis Medical Center in Macomb, Ohio as some of its 100 locations."

Answered by AI

Are people with the condition currently being accepted into the trial?

"That is correct. The clinical trial, which was first posted on 2018-09-17, is currently seeking patients. The most recent update was on 2021-11-08. They are hoping to enroll 1273 patients from 100 different sites."

Answered by AI

What is the target number of participants for this clinical trial?

"To enroll the 1273 patients required for this study, we are looking for individuals that fit the specified inclusion criteria and are willing to travel to one of our 21st Century Oncology MHP - Troy in Troy, Michigan or University of Chicago Comprehensive Cancer Center in Chicago, Missouri."

Answered by AI

What is the standard Quality-of-Life Assessment measuring?

"Quality-of-Life Assessment can be used to treat a diverse set of issues, such as scalp structure, kidney failure, acute burns, and other less severe burns."

Answered by AI

Who else is applying?

What state do they live in?
California
Other
Texas
Nevada
What site did they apply to?
City of Hope Comprehensive Cancer Center
University of Miami Miller School of Medicine-Sylvester Cancer Center
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

I have no libido and no desire to have *** I have a very hard time getting an erection.
PatientReceived no prior treatments
I've tried one other treatment office but it was only for a few months and then it stopped so I need to continue with this issue.
PatientReceived 1 prior treatment
I have low testosterone and also had a trans Urethal needle ablation. 5 years ago. Which I now have no libido and appear to have Ed.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Radiation Oncology Centers of Nevada Central: < 24 hours
Average response time
  • < 1 Day
~547 spots leftby Apr 2028