CLINICAL TRIAL

> 15% risk of + LN for Prostate Cancer

High Risk
Waitlist Available · 18+ · Male · Jacksonville, FL

This study is evaluating whether proton radiation combined with chemotherapy and hormonal therapy is safe and effective for patients with 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. > 15% Risk Of + LN is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
< 15% risk of + LN
RADIATION
Experimental Group 2
> 15% risk of + LN
RADIATION

Eligibility

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

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
* Adenocarcinoma of the prostate.
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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: 6 months after the completion of radiation therapy
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months after the completion of radiation therapy
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 months after the completion of radiation therapy.
View detailed reporting requirements
Trial Expert
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- 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 > 15% risk of + LN will improve 1 primary outcome and 2 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of After radiation: every 6 months for 3 years, then annually for 20 years.

Collect and Analyze Quality of Life, Treatment-related Late Morbidity, Disease Control, and Survival Outcome Parameters.
AFTER RADIATION: EVERY 6 MONTHS FOR 3 YEARS, THEN ANNUALLY FOR 20 YEARS
AFTER RADIATION: EVERY 6 MONTHS FOR 3 YEARS, THEN ANNUALLY FOR 20 YEARS
Collect and Analyze Treatment, Biologic and Diagnostic Information That May Impact Quality of Life, Disease Control, Morbidity and/or Survival Outcomes.
AFTER RADIATION: EVERY 6 MONTHS FOR 3 YEARS, THEN ANNUALLY FOR 20 YEARS
AFTER RADIATION: EVERY 6 MONTHS FOR 3 YEARS, THEN ANNUALLY FOR 20 YEARS
Acute Grade 3 or Higher Treatment-related Toxicity Rate.
6 MONTHS AFTER THE COMPLETION OF RADIATION THERAPY
Number of participants that experienced acute grade 3 or higher, treatment-related toxicity based on CTCAE version 3.0 criteria.
6 MONTHS AFTER THE COMPLETION OF RADIATION THERAPY

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 are common treatments for prostate cancer?

Common management of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) includes aggressive (ie. radical prostatectomy, radiation, hormonal deprivation. etc.) treatments, nontherapeutic (ie. watchful waiting, dietary counseling and lifestyle changes ) treatments, and salvage (ie. hormonal replacement therapy, radical radiotherapy) treatments. Nonintervention is recommended for the treatment of low or intermediate risk disease. Radical prostatectomy is considered a first-line treatment for advanced prostate cancer. It has higher rates of cure when compared with nonneoplastic changes in the prostate, but some complications cannot be avoided. Radiation therapy and hormonal therapy are used in most cases as a salvage procedure when the prostate cancer recurs after RP or hormonal therapy.

Anonymous Patient Answer

Can prostate cancer be cured?

Although some advances in treatment have been made over the years, as far as we know, the disease cannot be cured. However, we can improve patients' life, but only through careful and complete treatment of a localized tumor within the prostate gland. At this stage, when cancer presents in an asymptomatic phase, the patient should be informed on the fact this is a curable disease.

Anonymous Patient Answer

What causes prostate cancer?

Prostate cancer (carcinoma in the prostate gland) is generally a disease of middle-life, but the average time interval from diagnosis to death is much shorter than that for breast or colorectal cancer or lung cancer. These very short survival times suggest that a major cause other than age and time exposure to radiation may operate in prostate cancer. The cause(s) of prostate cancer and how these changes affect disease risk are not fully understood, but there is good evidence for an association with the consumption of drugs used for heart disease, diabetes and some of the neurological conditions and also a general elevation in blood triglyceride levels.

Anonymous Patient Answer

What is prostate cancer?

Prostate cancer can be prevented by taking steps such as not smoking or having a regular screening. Once prostate cancer has formed there may be other methods to treat it (treatment) which depends on which stage it has formed into. The effects on your lifestyle depend on which form it has formed into. Prostate cancer is a relatively easy to identify form for a doctor to diagnose and treat. It becomes harder for a doctor to choose a course of action to treat if the cancer has spread to other regions of the body (metastasis). It is important for men to have regular screenings, check up at regular intervals and keep the doctor fully informed.

Anonymous Patient Answer

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

The American Cancer Society estimates that 235,000 men will have [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) diagnosed in 2015. This makes prostate cancer the 13th most common cancer and the fifth most common cause of cancer death in males.

Anonymous Patient Answer

What are the signs of prostate cancer?

The signs of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) include: persistent urination disorder, frequent or painful urination, enlargement of prostatic gland, bloody or clear (blood-like) urine. Fever is a sign of prostate cancer, too, but has no predictive value. Men with signs of prostate cancer need to undergo a prostate test, but it is not necessary.

Anonymous Patient Answer

Is > 15% risk of + ln typically used in combination with any other treatments?

The combination of RT and/ or androgen ablation is typically used in LN-disease patients in the last 15 years, while patients with a > 15% risk belong to the > 50% category. The latter category may include patients to whom chemotherapy would not be an alternative therapeutic approach, such as in prostate cancer with a high risk of distant failure.

Anonymous Patient Answer

What is the latest research for prostate cancer?

All advances in PCA treatment are associated with increased benefits in survival. And, as expected, current advances will continue to further accelerate improvement in PCA treatment, overall survival and disease free survival. For example, new therapies such as the antiangiogenic (targeting the VEGF and TNF) agents and the androgen-deprivation therapy have been introduced. And there will be more and more new drug classes that will get introduced in the next 5 years in both developed and developing countries. For example, the antiangiogenic agents such as bevacizumab have been introduced in the last sixmonths in several developed countries.

Anonymous Patient Answer

Has > 15% risk of + ln proven to be more effective than a placebo?

Overall, the results from this randomised, placebo-controlled, multicenter phase II trial do not provide strong evidence that a high-risk regimen of EBRT reduces the probability of dying from prostate cancer compared with a placebo. However, the number of deaths in the treatment arm is so low that any benefit is likely to be detected if the high risk group was larger in number. On the other hand, it is not clear which treatment strategy is best for patients with more than 15% risk.

Anonymous Patient Answer

What is the survival rate for prostate cancer?

As we summarize data from this large retrospective case-control study, 5-year survival was 63.0% for the prostatic cancer group, which is much better than that (29.1%) of the general population. The prostate cancer survivors had a very good quality of life even 20 years after diagnosis.

Anonymous Patient Answer

Does > 15% risk of + ln improve quality of life for those with prostate cancer?

The number of risk categories was relatively small and this may have reduced the apparent significance of results compared to other studies with larger risk groups.

Anonymous Patient Answer

How quickly does prostate cancer spread?

For staging clinically localized [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer), the Gleason score is a valuable tool in predicting whether cancer has spread. When the Gleason score of prostate cancer is > or =6, the cancer must have spread. PSA level and the clinical stage may also be used as aids in assessing what extent of prostate surgery is advisable for patients at risk for prostate cancer. The time interval between the performance of biopsy and definitive surgical treatment of prostate cancer in patients with prostate cancer is currently longer than the time between the performance of biopsy and diagnosis of other types of cancer, because of a relatively slow tumor growth.

Anonymous Patient Answer
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