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Enzalutamide + SRT for Prostate Cancer

Q: Has Enzalutamide been certified by the FDA?

<p>There is evidence of safety for <a href="https://www.withpower.com/clinical-trials/enzalutamide">Enzalutamide</a>, but no data suggesting efficacy yet. Accordingly, it received a rating of 2 on the scale from 1 to 3.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years from end of therapy

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Select...

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Freedom of PSA (Prostate Specific Antigen) progression

Secondary outcome measures

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%

Diarrhoea

13%

Constipation

12%

Pain in extremity

12%

Weight decreased

11%

Anaemia

11%

Musculoskeletal pain

Hypertension

Oedema peripheral

Dizziness

Haematuria

Insomnia

Hot flush

Malignant neoplasm progression

Muscular weakness

General physical health deterioration

Vomiting

Dyspnoea

Spinal cord compression

Renal failure acute

Pneumonia

Pulmonary embolism

Cardiac failure

Pyrexia

Urinary tract infection

Lower respiratory tract infection

Neutropenia

Metastases to central nervous system

Lung disorder

Renal failure

Osteoarthritis

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

~2760

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Astellas Pharma IncIndustry Sponsor

690 Previous Clinical Trials

231,943 Total Patients Enrolled

36 Trials studying Prostate Cancer

8,642 Patients Enrolled for Prostate Cancer

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

557 Previous Clinical Trials

32,804 Total Patients Enrolled

57 Trials studying Prostate Cancer

3,348 Patients Enrolled for Prostate Cancer

Medivation, Inc.Industry Sponsor

75 Previous Clinical Trials

11,146 Total Patients Enrolled

12 Trials studying Prostate Cancer

668 Patients Enrolled for Prostate Cancer

Media Library

Salvage Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT02203695 — Phase 2

Prostate Cancer Research Study Groups: SRT plus Enzalutamide, SRT plus placebo

Prostate Cancer Clinical Trial 2023: Salvage Radiation Therapy Highlights & Side Effects. Trial Name: NCT02203695 — Phase 2

Salvage Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT02203695 — Phase 2

Frequently Asked Questions

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

Has Enzalutamide been certified by the FDA?

"There is evidence of safety for Enzalutamide, but no data suggesting efficacy yet. Accordingly, it received a rating of 2 on the scale from 1 to 3."

Answered by AI

Am I eligible to become a participant in this experiment?

"In order to be eligible for this medical research, contenders must possess adenocarcinoma and fall within the age bracket of 18-100. This trial is currently seeking roughly 96 participants."

Answered by AI

How many participants are enrolled in this clinical research?

"Unfortunately, no patients are currently being enrolled as this study is not actively recruiting. It was initially posted on March 28th 2015 and revised February 3rd 2022. Individuals looking for other trials should note that there are presently 779 studies seeking adenocarcinoma sufferers and 98 investigations requiring Enzalutamide candidates."

Answered by AI

Is the age limit for participation in this trial beyond thirty years?

"In order to be eligible for this trial, applicants must range from 18-100 years old. There are 8 studies specifically designed for individuals below the legal age of consent and 876 clinical trials available to patients over 65."

Answered by AI

How many sites are engaged in the execution of this trial?

"Currently, this clinical trial is available at 9 centres. Detroit, Bethesda and Portland are 3 of the locations that offer these services; there are 6 other cities taking part in the study as well. To reduce travel time for participants it may be beneficial to pick a location close by."

Answered by AI

What other research endeavors have been conducted pertaining to Enzalutamide?

"Since its discovery in 2005 at Rosemere Cancer Centre, there have been 86 completed studies regarding enzalutamide. Currently, 98 live clinical trials are underway with many based out of Detroit, Michigan."

Answered by AI

Are recruitment efforts for this research project still going on?

"This particular study is not open to recruitment at this moment. Its original posting date was March 28th 2015, and its last edit on February 3rd 2022. Those looking for other trials may be interested in the 779 medical studies recruiting patients with adenocarcinoma or the 98 clinical trials involving Enzalutamide that are actively enrolling participants."

Answered by AI

Recent research and studies

BMC CancerJournal

A Phase II Randomized Placebo-controlled Double-blind Study of Salvage Radiation Therapy Plus Placebo Versus SRT Plus Enzalutamide with High-risk Psa-recurrent Prostate Cancer After Radical Prostatectomy (SALV-ENZA)

Kapoor, Roche, Matthew P. Deek, Riley McIntyre, Natasha Raman, Megan Kummerlowe, Iyah Chen, Matt Gaver, et al.. 2019. “A Phase II Randomized Placebo-controlled Double-blind Study of Salvage Radiation Therapy Plus Placebo Versus SRT Plus Enzalutamide with High-risk Psa-recurrent Prostate Cancer After Radical Prostatectomy (SALV-ENZA)”. BMC Cancer. Springer Science and Business Media LLC. doi:10.1186/s12885-019-5805-z.

clinicaltrials.govStudy

Randomized Salvage Radiation Therapy Plus Enzalutamide Post Prostatectomy

2015. "Randomized Salvage Radiation Therapy Plus Enzalutamide Post Prostatectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02203695.

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