CLINICAL TRIAL

flutamide for Prostate Cancer

Metastatic
Waitlist Available · 18+ · Male · Philadelphia, PA

This study is evaluating whether radiation therapy is more effective than radiation therapy given together with androgen-deprivation therapy in treating patients with prostate cancer.

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About the trial for Prostate Cancer

Eligible Conditions
Prostatic Neoplasms · Prostate Cancer

Treatment Groups

This trial involves 2 different treatments. Flutamide is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
flutamide
DRUG
intensity-modulated radiation therapy
RADIATION
buserelin
DRUG
triptorelin
DRUG
bicalutamide
DRUG
3-dimensional conformal radiation therapy
RADIATION
goserelin acetate
DRUG
leuprolide acetate
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
intensity-modulated radiation therapy
RADIATION
3-dimensional conformal radiation therapy
RADIATION

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Flutamide
FDA approved
intensity-modulated radiation therapy
2008
Completed Phase 3
~1230
Buserelin
FDA approved
Triptorelin
FDA approved
Bicalutamide
FDA approved
3-dimensional conformal radiation therapy
2007
Completed Phase 3
~2750
Goserelin
FDA approved
Leuprolide
FDA approved

Eligibility

This trial is for male patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Primary tumor staging for eligibility purposes is to be based on palpable or core biopsy evidence only with respect to extracapsular extension or seminal vesicle involvement
Gleason score = 7
Prostate Specific Antigen (PSA) > 10 and ≤ 20 ng/mL
Baseline serum PSA value performed within 60 days with an FDA-approved assay (e.g., Abbott, Hybritech)
Baseline PSA must not be obtained during any of the following time frames:10-day period after prostate biopsy, after initiation of androgen-deprivation therapy, or within the past 30 days after discontinuation of finasteride (90 days for dutasteride)
Clinical stage T2b or T2c disease
Patients previously diagnosed with low-risk (Gleason score < 6, clinical stage < T2a, and PSA < 10 ng/mL) prostate cancer undergoing active surveillance who are re-biopsied and found to have intermediate-risk disease according to the protocol criteria are eligible for enrollment within 6 months of the repeat biopsy procedure
Patients with Gleason Score ≥ 8, PSA > 20 ng/mL, OR clinical stage ≥ T3 are ineligible for this trial
If findings of extracapsular extension or seminal vesicle invasion are noted on prostate MRI, this study, if used, will not render patients ineligible for accrual to this protocol
No patients with all 3 intermediate-risk factors who also have ≥ 50% of the number of their biopsy cores positive for cancer
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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: From date of randomization to the following times: last week of RT, 6 months, 1 year and 5 years post RT.
Screening: ~3 weeks
Treatment: Varies
Reporting: From date of randomization to the following times: last week of RT, 6 months, 1 year and 5 years post RT.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From date of randomization to the following times: last week of RT, 6 months, 1 year and 5 years post RT..
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 and 15 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of From the date of randomization to the date of death due to any cause..

Rates of OS for patients treated with the 3 different radiotherapy modalities in each arm
FROM THE DATE OF RANDOMIZATION TO THE DATE OF DEATH DUE TO ANY CAUSE.
FROM THE DATE OF RANDOMIZATION TO THE DATE OF DEATH DUE TO ANY CAUSE.
Freedom from Failure
FROM DATE OF RANDOMIZATION TO THE DATE OF FIRST EVENT OF BIOCHEMICAL FAILURE OR LOCAL RECURRENCE OR REGIONAL RECCURRENCE OR DISTANT METASTASIS.
FROM DATE OF RANDOMIZATION TO THE DATE OF FIRST EVENT OF BIOCHEMICAL FAILURE OR LOCAL RECURRENCE OR REGIONAL RECCURRENCE OR DISTANT METASTASIS.
Non-prostate cancer-specific mortality
FROM THE DATE OF RANDOMIZATION TO THE DATE OF DEATH WITHOUT THE EVIDENCE OF PROSTATE CANCER/COMPLICATION OF TREATMENT.
FROM THE DATE OF RANDOMIZATION TO THE DATE OF DEATH WITHOUT THE EVIDENCE OF PROSTATE CANCER/COMPLICATION OF TREATMENT.
Local recurrence
FROM THE DATE OF RANDOMIZATION TO THE DATE OF FIRST PALPABLE PROGRESSION OR PATHOLOGIC CONFIRMATION OF LOCAL PROGRESSION OR TO THE DATE OF FIRST BIOCHEMICAL FAILURE (NADIR +2NG/ML) ONCE THE POSSIBILITY OF DISTANT METASTASIS IS RULED OUT.
FROM THE DATE OF RANDOMIZATION TO THE DATE OF FIRST PALPABLE PROGRESSION OR PATHOLOGIC CONFIRMATION OF LOCAL PROGRESSION OR TO THE DATE OF FIRST BIOCHEMICAL FAILURE (NADIR +2NG/ML) ONCE THE POSSIBILITY OF DISTANT METASTASIS IS RULED OUT.
Biochemical failure according to the Phoenix (nadir + 2) definition
FROM THE DATE OF RANDOMIZATION TO THE DATE OF FIRST DOCUMENTED RISE IN PSA OF 2 NG/ML ABOVE THE POST TREATMENT NADIR VALUE.
FROM THE DATE OF RANDOMIZATION TO THE DATE OF FIRST DOCUMENTED RISE IN PSA OF 2 NG/ML ABOVE THE POST TREATMENT NADIR VALUE.
Correlation between the fatigue PROMIS score change and plasma cytokine change
FROM DATE OF RANDOMIZATION TO 3 WEEKS FROM START OF RT.
FROM DATE OF RANDOMIZATION TO 3 WEEKS FROM START OF RT.
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Patient Q & A Section

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

How does flutamide work?

Findings from a recent study suggest that the mechanism of action of antiandrogens is complex, but that specific inhibition of AR signaling may override the more general effects of androgens in prostate carcinogenesis.

Anonymous Patient Answer

What are common treatments for prostate cancer?

As treatment options for prostate cancer have improved over the last 25 years due to increased awareness, education and treatment, most patients are now able to choose to receive a variety of management options, including surgery, radiation therapy and some newer medication based treatments. These options make prostate cancer a very treatable disease.

Anonymous Patient Answer

What is prostate cancer?

Prostate is the most common cancer in males. The American Cancer Society estimates that there will be more than 178,000 new cases and more than 68,000 related deaths per year in the US in 2019. Prostate cancer is classified based on the Gleason scoring system as well as the percentage of cancer in the prostate. The lower the percentage of cancer in the prostate and the lower the Gleason score, the lower the risk for prostate cancer.

Anonymous Patient Answer

What are the signs of prostate cancer?

Prostate cancer is not a rare disease that has many common signs and symptoms; it is more likely to be diagnosed after it has already metastasized.

Anonymous Patient Answer

Can prostate cancer be cured?

Men and women and many healthcare professionals hold the belief that cancer can be cured, even when there is significant evidence of the contrary. Data from a recent study is a first step in understanding the factors associated with a belief that cancer can be cured. Data from a recent study suggest that many doctors and patients, particularly in the context of [advanced prostate cancer](https://www.withpower.com/clinical-trials/advanced-prostate-cancer), are more likely to interpret symptoms as signs of an underlying progressive disease if they also expect a cure will be achieved. Understanding the belief that cancer can be cured, and the factors associated with this belief, will help us design effective and informative treatment for people with prostate cancer.

Anonymous Patient Answer

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

The US Preventive Cervical Cancer Task Force (2009) identified the need to more fully characterize the burden of PCa and its natural history to guide its prevention, including the development of recommendations to minimize the number of men at high risk for PCa. A detailed review is required to characterize the burden of PCa and the natural history of this disease, including disease and death from PCa and causes of PCa in males.

Anonymous Patient Answer

What causes prostate cancer?

A number of rare alleles at several well-studied loci were identified that may increase the risk of prostate cancer. Other genes or loci that could be causal agents have yet to be discovered.

Anonymous Patient Answer

Is flutamide typically used in combination with any other treatments?

Testicular cancer is not only treated with or without orchiectomy. It must be kept in mind when evaluating flutamide therapy in terms of oncological outcomes.

Anonymous Patient Answer

What is the average age someone gets prostate cancer?

Prostate cancer typically presents as a slow-growing prostate cancer in patients who have experienced prostatic enlargement that occurs at an average age of 72 years.

Anonymous Patient Answer

What are the chances of developing prostate cancer?

Results from a recent clinical trial indicates that approximately one in 6 men in the general population have BPH. Of these men, approximately one in 9 will develop prostate cancer with approximately 70 in 1 million men at risk from prostate cancer. The likelihood of developing prostate cancer increases with age, and the five-year risks for Caucasian, African American or Hispanic men is in the range of 9.5%-16.9% and 8.0%-17.2%, respectively.

Anonymous Patient Answer

Have there been other clinical trials involving flutamide?

Results from a recent paper of the meta-analysis indicates that the two existing randomized, placebo-controlled clinical trials and one observational study evaluating the efficacy of flutamide in the treatment of prostate cancer could not find a statistically significant superiority of flutamide compared to placebo. There appears to be no compelling rationale for the use of flutamide as treatment in prostate cancer. More trials examining the efficacy of flutamide are necessary.

Anonymous Patient Answer

How quickly does prostate cancer spread?

Findings from a recent study of this study are very encouraging for the detection of the spread of prostate cancer. Despite the PSA group presenting an increase in the incidence of metastatic disease, in patients that had a Gleason score of 7 to 10 the risk group was undetectable. This demonstrates the ability of PSA to detect early spread of prostate cancer and the need for alternative markers of the disease to be used.

Anonymous Patient Answer
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