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Enzalutamide + SRT for Prostate Cancer

Phase 2

Waitlist Available

Led By Phuoc Tran, M.D.

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have evidence of biochemical (PSA) relapse after prostatectomy

Patients must have non-castrate levels of serum testosterone levels within study range

Must not have

Clinically significant cardiovascular disease including: myocardial infarction within 6 months of Screening visit, uncontrolled angina within 3 months of Screening visit, congestive heart failure (within certain ranges), history of clinically significant ventricular arrhythmias, prolonged corrected QT interval, history of Mobitz II second degree or third degree heart block without a permanent pacemaker in place, hypotension within certain ranges, uncontrolled hypertension within certain ranges, medications which lower seizure threshold, history of seizure or any condition that may predispose to seizure including, but not limited to underlying brain injury, stroke, primary brain tumors, brain metastases, or alcoholism, history of loss of consciousness or transient ischemic attack within 12 months of enrollment (Day 1 visit), patients taking medications that may have adverse interactions with enzalutamide

Serious concurrent medical illnesses (including uncontrolled major cardiac, pulmonary, Child-Pugh C liver or psychiatric diseases) or active major infections (including HIV, Hepatitis A-C)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years from end of therapy

Summary

This trial is testing whether adding the drug enzalutamide to standard radiation therapy for prostate cancer that has come back after surgery will improve outcomes.

Who is the study for?

Men over 18 with prostate cancer that's come back after surgery, but hasn't spread to other parts of the body. They must have a certain PSA level and can't have had hormone therapy before (except with surgery). Participants need good overall health, no serious heart or psychiatric conditions, and they must agree to use two forms of birth control if their partner could get pregnant.

What is being tested?

The trial is testing whether adding Enzalutamide (a powerful anti-androgen drug) for six months improves outcomes in men whose prostate cancer returned post-surgery compared to just salvage radiation therapy. The goal is to see if this combination helps more than standard care without causing too many side effects.

What are the potential side effects?

Enzalutamide may cause fatigue, back pain, constipation, joint pain, and hot flashes. It might also affect thinking or cause dizziness. Since it's being combined with radiation therapy, there could be additional side effects like skin irritation where the radiation is aimed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer has returned, shown by rising PSA levels after surgery.

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My testosterone levels are not low and within the study's required range.

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My cancer is adenocarcinoma of the prostate.

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My cancer has not spread to other parts of my body, confirmed by recent scans.

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My cancer had not spread to my lymph nodes at the time of surgery.

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I can swallow pills whole.

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I am mostly active and my doctor expects me to live more than 3 years.

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I had surgery to remove my prostate as the first treatment.

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I am a man aged 18 or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have serious heart issues, seizures, or conditions that could cause seizures.

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I do not have serious illnesses like heart, lung, severe liver conditions, or major infections.

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My main cancer treatment is radiation therapy.

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I am not using any other cancer treatments.

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I am not taking any other antiandrogens, estrogen-like agents, or 5a-reductase inhibitors.

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My cancer has come back in the area where it was first found.

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I have another type of cancer that is currently active.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years from end of therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years from end of therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years from end of therapy for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Freedom of PSA (Prostate Specific Antigen) progression

Secondary study objectives

Adverse Events Encountered

Feasibility of achieving stated accrual

How well participants tolerate treatment

+2 more

Side effects data

From 2017 Phase 4 trial • 215 Patients • NCT02116582

34%

Fatigue

25%

Decreased appetite

18%

Asthenia

17%

Back pain

16%

Arthralgia

15%

Nausea

13%

Bone pain

13%

Constipation

13%

Diarrhoea

12%

Pain in extremity

12%

Weight decreased

11%

Anaemia

11%

Musculoskeletal pain

Hypertension

Oedema peripheral

Haematuria

Dizziness

Malignant neoplasm progression

Insomnia

Hot flush

Muscular weakness

General physical health deterioration

Vomiting

Dyspnoea

Spinal cord compression

Renal failure acute

Pulmonary embolism

Pneumonia

Pyrexia

Renal failure

Neutropenia

Cardiac failure

Lower respiratory tract infection

Osteoarthritis

Urinary tract infection

Metastases to central nervous system

Lung disorder

100%

80%

60%

40%

20%

Study treatment Arm

Enzalutamide Total

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SRT plus EnzalutamideExperimental Treatment1 Intervention

Arm 2 (experimental): (SRT) Salvage radiation therapy (Three dimensional conformal radiation therapy (3D-CRT)/IMRT \[Intensity-modulated radiation therapy\]) 66.6-70.2 Gy as 1.8 Gy M-F for 37-39 fx PLUS Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)

Group II: SRT plus placeboPlacebo Group1 Intervention

Arm 1 (control): Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT (Intensity-modulated radiation therapy)) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx PLUS Placebo PO daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enzalutamide

2014

Completed Phase 4

~3820

0 / 16Eligibility criteria met