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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

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 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.
Select...
My prostate is intact and I haven't had any treatment for prostate cancer.
Select...
My scans show cancer has spread and I've had these tests within the last 42 days.
Select...
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 seen a urologist and my disease can be surgically removed.
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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 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.
Select...
My condition did not worsen while on hormone therapy.
Select...
I have seen a urologist and my condition can be treated with surgery.
Select...
I am not planning to receive docetaxel treatment after being assigned to a study group.
Select...
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%
Blurred vision
2%
Acute kidney injury
2%
Hemorrhoids
2%
Hypothyroidism
2%
Urticaria
2%
Palpitations
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%
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

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
Radical Prostatectomy
2005
Completed Phase 2
~4550
Triptorelin
2017
Completed Phase 4
~1370
Radiation Therapy
2017
Completed Phase 3
~7250
Abiraterone
2012
Completed Phase 4
~2830
Bicalutamide
2003
Completed Phase 3
~5330
Degarelix
2002
Completed Phase 3
~3600
Flutamide
2013
Completed Phase 4
~1980
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
263,347 Total Patients Enrolled
27 Trials studying Prostate Cancer
53,550 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,721 Previous Clinical Trials
40,963,857 Total Patients Enrolled
566 Trials studying Prostate Cancer
529,204 Patients Enrolled for Prostate Cancer
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
259,988 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
~502 spots leftby Apr 2028
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