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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

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.

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.

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.

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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 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.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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

Back pain

Headache

Nervous system disorders - Other, specify

Pain in extremity

General disorders and administration site conditions - Other, specify

Skin infection

White blood cell decreased

Hypercalcemia

Hypokalemia

Musculoskeletal and connective tissue disorder - Other, specify

Dizziness

Respiratory, thoracic and mediastinal disorders - Other, specify

Eye disorders - Other, specify

Hyperkalemia

Pain

Alkaline phosphatase increased

Hypocalcemia

Cough

Flushing

Tinnitus

Dental caries

Gastrointestinal disorders - Other, specify

Hemoglobin increased

Weight loss

Metabolism and nutrition disorders - Other, specify

Dysgeusia

Anxiety

Irregular menstruation

Menorrhagia

Sore throat

Lymphocyte count decreased

Hyperuricemia

Non-cardiac chest pain

Infections and infestations - Other, specify

Hypernatremia

Hypoglycemia

Scalp pain

Dry mouth

Blurred vision

Hypothyroidism

Urticaria

Hemorrhoids

Acute kidney injury

Palpitations

Leukocytosis

Myocardial infarction

Vertigo

Anal hemorrhage

Dysphagia

Esophageal pain

Periodontal disease

Fever

Sinusitis

Urinary tract infection

Bruising

Dermatitis radiation

Cholesterol high

Creatinine increased

Neck pain

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Concentration impairment

Memory impairment

Spasticity

Depression

Insomnia

Allergic rhinitis

Productive cough

Sleep apnea

Pregnancy, puerperium and perinatal conditions - Other, specify

Dry eye

Lymphedema

Chest pain - cardiac

Heart failure

Gastric perforation

Hypertriglyceridemia

Dyspnea

Cardiac disorders - Other, specify

Gastroesophageal reflux disease

Oral dysesthesia

Chills

Hypophosphatemia

Chest wall pain

Psychiatric disorders - Other, specify

Hematuria

Urinary tract obstruction

Dysmenorrhea

Skin hypopigmentation

Unintended pregnancy

Flu like symptoms

Nail infection

Pancreatitis

Blood and lymphatic system disorders - Other, specify

Oral pain

Fall

100%

80%

60%

40%

20%

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

Radical Prostatectomy

2005

Completed Phase 2

~4550