CLINICAL TRIAL

Flutamide for Prostate Cancer

Recruiting · 18+ · Male · Baltimore, MD

This study is evaluating whether a drug may help prostate cancer patients recover from radiation therapy.

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About the trial for Prostate Cancer

Treatment Groups

This trial involves 2 different treatments. Flutamide is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Flutamide
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
OTHER

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Flutamide
FDA approved

Side Effect Profile for Flutamide

Flutamide
Show all side effects
38%
headache
31%
stomach pain
23%
dry skin
15%
Diarrhea
15%
hot flushes
15%
nausea
15%
insomnia
8%
dry mouth
8%
leg pain
8%
fatigue
8%
parasthesia
0%
constipation
headache
38%
stomach pain
31%
dry skin
23%
Diarrhea
15%
hot flushes
15%
nausea
15%
insomnia
15%
dry mouth
8%
leg pain
8%
fatigue
8%
parasthesia
8%
constipation
0%
This histogram enumerates side effects from a completed 2011 Phase 4 trial (NCT00611923) in the Flutamide ARM group. Side effects include: headache with 38%, stomach pain with 31%, dry skin with 23%, Diarrhea with 15%, hot flushes with 15%.

Eligibility

This trial is for male patients aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
A disease that is detectable through physical examination and is related to (located on the same side as) any cancerous tissue found through a biopsy. show original
I agree to participate in this study and have read and understood the consent form show original
Histologically confirmed prostate cancer
was found in each of the 10 cores sampled Every one of the 10 cores sampled had at least one biopsy core with Gleason 7 or higher disease. show original
The patient has chosen to have brachytherapy plus androgen suppression as his treatment for prostate cancer show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6-9 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 6-9 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6-9 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Flutamide will improve 1 primary outcome in patients with Prostate Cancer. Measurement will happen over the course of 6-9 months.

time to DNA double strand break
6-9 MONTHS
To confirm DNA double strand breaks occur in prostate cancer tissue following pulse-dose flutamide administration in patients who are androgen suppressed, as compared to control patients receiving placebo.
6-9 MONTHS

Patient Q & A Section

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

What is the primary cause of prostate cancer?

Our epidemiology study on the age and distribution of primary cause of radical prostatectomy (surgery, radiation or a combination of the two) in a large institution in Israel suggests that [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) is primarily a disease of aging, and more so in those with a family history of the disease. It is suggested that the primary cause of prostate cancer is related to age and/or familial predisposition of the disease, especially in those with multiple and/or synchronous primary cancer.

Anonymous Patient Answer

What are common treatments for prostate cancer?

Treatment for prostate cancer is quite complex. Although many possible treatments exist, there is no single 'best' treatment for any given patient. Instead, the treatment regimen should include consultation with an experienced clinician specializing in prostate cancer (urologist, andropractic surgeon, or radiation oncologist), consideration of the patient's comorbidities, age, and life expectations, as well as the benefits and risks of treatment options.

Anonymous Patient Answer

What are the signs of prostate cancer?

All signs of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) can generally be described as lumping signs or symptoms. Although lumping signs and symptoms have generally been described to occur before prostate-specific antigen (PSA) testing is available, they seem to be part of a gradual deterioration of the prostate due to androgens. The most critical signs are the sudden and total loss of semen and sudden and total loss of urine and other signs of stress, which are the same signs and symptoms of other diseases that can decrease the ability to recognize prostate cancer. Patients are recommended to seek the opinions of a physician that sees patients who have these clinical signs, symptoms and/or biochemical alterations due to prostate cancer, and have their medical histories evaluated.

Anonymous Patient Answer

How many people get prostate cancer a year in the United States?

We found a high prevalence of prostate cancer in patients with schizophrenia. This prevalence was similar to the general population in this area, which is important to remember for health planning purposes. However, despite the high prevalence of prostate cancer, only one patient was treated surgically because of it and only 11% received and benefited from treatment for prostate cancer. A review of these findings highlights the need for screening all patients with schizophrenia for prostate cancer. This will, however, have a low impact in reducing the morbidity of prostate cancer.

Anonymous Patient Answer

Can prostate cancer be cured?

Although the results of modern treatment of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) are not encouraging, further investigations are needed for the identification of biomarkers that can indicate cancer cure before its return.

Anonymous Patient Answer

What causes prostate cancer?

The cause of prostate cancer is unknown and the role of exposure to radiation is unclear, but it is likely due to a combination of factors. It can occur in smokers, and to a certain degree without.

Anonymous Patient Answer

What is prostate cancer?

There are several [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer)s that are named based on the tissue origin from which they develop. In the United States prostate cancer is mainly the prostate gland, which can produce symptoms. In 2015, cancer of the prostate was the eighth-most common cause of death among males in the world. It is the most common cause of death in men aged 75 to 74. It is the cause of 6 percent of deaths among people aged 80 and older. Onset of prostate cancer can be early or late. About half the cases arise between ages 65 and 74, often over as long as 20 years.

Anonymous Patient Answer

Have there been other clinical trials involving flutamide?

A wide variety of flutamide-related clinical trials were conducted in an effort to clarify the pharmacology. All flutamide-related trials were of very poor academic quality and included small numbers of patients and trials. Therefore, in the absence of new clinical research, the clinical significance and safety of flutamide cannot be proven. Further well-designed trials are expected to improve the therapeutic balance of interest.

Anonymous Patient Answer

Does prostate cancer run in families?

In a population of unselected male patients suffering from prosteatitis uropygialis, we found a significantly increased risk to develop prostate cancer in the first-degree relatives of patients with prostatitis uropygialis and their offspring, compared to the control population. Genetic factors might explain the increased familial risk to development of prostate cancer in a subset of patients.

Anonymous Patient Answer

What does flutamide usually treat?

The treatment of metastatic castration resistance prostate disease with flutamide and prednisone (FP) or monoclonal antibody therapy can result in a significant prolongation of life and a significant improvement of signs and symptoms that occur after the development of castration-resistant prostate cancer. However, this treatment should be used with caution in patients who have not previously received androgen deprivation therapy (ADT), because of the likelihood and severity of side effects of ADT as well as the rapid development of ADT-resistant disease.

Anonymous Patient Answer

What are the latest developments in flutamide for therapeutic use?

Recent development of new flutamide formulations for therapeutic use represents an innovative technology that should be widely adopted for treatment of prostate cancer before definitive evaluation for diagnostic utility in prospective clinical phase III studies has been initiated.

Anonymous Patient Answer

Is flutamide safe for people?

Flutamide is safe and has been approved by regulatory authorities, including the FDA, EMA and MHRA, for use in breast and prostate cancer in men. Although flutamide is typically given up to five consecutive days a week, the results from these clinical trials suggest that flutamide is also effective when used on a daily administration. The safety is similar to that reported for orchiectomy and castration.

Anonymous Patient Answer
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