GnRH analog for Prostate Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
WellSpan Health - Ephrata Cancer Center, Ephrata, PA
Prostate Cancer+1 More
GnRH analog - Drug
Eligibility
18+
Male
Eligible conditions
Prostate Cancer

Study Summary

This study is evaluating whether a combination of radiation and hormone therapy may help patients with prostate cancer.

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Eligible Conditions

  • Prostate Cancer
  • Prostatic Neoplasms

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether GnRH analog will improve 1 primary outcome in patients with Prostate Cancer. Measurement will happen over the course of From the date of randomization to the date of progression, death from any cause or last known follow-up date, assessed up to 5 years..

Year 5
Progression-Free Survival (PFS)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

Salvage Radiation Therapy + Standard ADT
Salvage Radiation Therapy + Enhanced ADT

This trial requires 242 total participants across 2 different treatment groups

This trial involves 2 different treatments. GnRH Analog 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 2 and have already been tested with other people.

Salvage Radiation Therapy + Enhanced ADTSalvage RT will be given 66.0 - 70.2 Gy along with 24 months of a GnRH analog + 24 months of enzalutamide.
Salvage Radiation Therapy + Standard ADTSalvage RT will be given 66.0 - 70.2 Gy along with 24 months of a GnRH analog with or without 1-4 months of bicalutamide.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Goserelin
FDA approved
Radiation Therapy
2005
Completed Phase 3
~7080
Enzalutamide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from the date of randomization to the date of progression, death from any cause or last known follow-up date, assessed up to 5 years.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from the date of randomization to the date of progression, death from any cause or last known follow-up date, assessed up to 5 years. for reporting.

Closest Location

WellSpan Health - Ephrata Cancer Center - Ephrata, PA

Eligibility Criteria

This trial is for male patients aged 18 and older. You must have received 1 prior treatment for Prostate Cancer or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Pathologically (histologically) confirmed adenocarcinoma of the prostate, any type, is permitted, including retropubic, perineal, laparoscopic or robotically assisted, if it was surgically removed (prostatectomy) within 10 years prior to registration. show original
The participants must have a PSA level of at least 0.2 ng/mL within 90 days of registration, and they must start using a GnRH analog no more than 42 days before their study entry. show original
The participant must have a hemoglobin level of at least 9.0 grams per deciliter (g/dL) within 90 days prior to registration, regardless of whether or not they have received a transfusion or growth factors. show original
The patient has a platelet count of at least 75,000 x 10^9/µL, whether or not they have received a blood transfusion or growth factors in the 90 days prior to registration. show original
The person must have a serum albumin level of at least 3.0 g/dL within 90 days prior to registration. show original
The Gleason score is a measure of how aggressive a cancer is show original
higher than pT3 is not) Invasion of the seminal vesicles is eligible for surgery provided that it is at a stage lower than pT3. show original
If a tumor is classified as pT3b, it is considered to be aggressive. show original
is a predictor for adverse oncologic outcomes show original
Persistently elevated PSA post-RP nadir (PEPP) defined as PSA > 0.1 ng/mL after radical prostatectomy

Patient Q&A Section

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

Can prostate cancer be cured?

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The cancer is not curable. The best results can sometimes be achieved by a combination of surgery, radiation, and watchful waiting. A curative treatment plan depends on the stage of the disease, the person's age, his/her preferences and general health status.

Unverified Answer

What are common treatments for prostate cancer?

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The treatments for prostate cancer are very diverse because of the complexity of its development. In addition to the known treatments and drugs, some treatments are still under investigation. While specific treatment of prostate cancer is difficult, our review describes the common treatment options in prostate cancer.

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What is prostate cancer?

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It is the second most common type of cancer worldwide occurring in the prostate gland and the inner organs. A cancer that can be deadly, it is only treatable when caught early and there are many screening tests available that help find the cancer early. Cancer of the prostate is the most common form of cancer worldwide in males. theme:

biogeography question: Is the biogeography of the plant family Proteaceae : The continent of Gondwana a haven for the family? answer: The Australian region retains one of the richest and densest native flora of the world and retains a much higher level than other continents at present and in the recent past, a stark contrast to the present cosmopolitan flora of neighbouring continents.

Unverified Answer

Who should consider clinical trials for prostate cancer?

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Although the clinical trial protocol is a major determinant of inclusion in a trials, there is no absolute determinant for study participation because treatment selection also depends largely on the individual patients' willingness to be included. The authors contend that clinical trials may be inappropriate for the patients older than 75 years who experience little benefit and considerable risk and those younger than 75 who have relatively minor symptoms and minimal impairment in functional status.

Unverified Answer

What are the signs of prostate cancer?

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The presenting symptoms of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) are typically nonspecific. The most common symptoms of prostate cancer are difficulty urinating or inability to urinate, an irregularly shaped lump in the prostate, pain caused by prostate swelling or the spread of cancer to the lymph nodes, back pain, or bone pain. However symptoms of prostate cancer may occur in combination. The most common symptoms of prostate cancer are pain, difficulty talking and difficulty getting urinated. The signs of prostate cancer are also nonspecific. Symptoms may include pain, swelling, itchiness and an enlarged prostate gland. Other potential symptom, depending on their location, may include a lump, unusual discharge from the penis or pain near the penis.

Unverified Answer

What causes prostate cancer?

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There is much debate relating to the causes of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer). Current trends of incidence show a peak rate in adolescence, similar to that of many other cancers. It has been theorised that puberty and the physiological changes associated with increased sex hormones have a role. Other risk factors have been highlighted including exposures to UV-light, and occupational toxins, particularly dioxins in tobacco smoke, and in grain processing and pesticide spraying. However, the evidence supporting these theories is questionable; this is especially true for the role of UV-light. Exposure to cigarette smoking and cannabis are also associated with the onset of prostate cancer, although the evidence for the link is also disputed.

Unverified Answer

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

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Between 1991 and 1999, there were an estimated 49.9 million new cases of prostate cancer in the U.S., with 47.1 percent diagnosed while alive. The prevalence of newly diagnosed prostate cancer is high: between 25 and 33 percent in men over 60 years of age in several population-based or university or academic institution-based studies of either a hospital based or a population-based setting. Although incidence is rising, the number of new cases has not increased at a rate consistent with the prevalence. The risk for prostate cancer is highest among men over 70 years of age, as well as among men in their 50s.

Unverified Answer

What is the survival rate for prostate cancer?

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The 5-year survival rate for prostate cancer in our region is 71.6% (n=844) in a population-based survey, whereas the 5-year survival rate for prostate cancer in the United States was 75.6% in 2001. The differences may be due to the earlier detection and diagnosis of prostate cancer in the United States or the use of modern diagnostic methods.

Unverified Answer

What are the chances of developing prostate cancer?

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Prostate cancer has a substantial risk and is a major cause of morbidity and mortality in men between the ages of 50 and 80. The most common risk factor for developing [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) is age at prostate-specific antigen (PSA) examination.

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Has gnrh analog proven to be more effective than a placebo?

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GnRH analogs have demonstrated to be more effective than placebo for the treatment of prostate hyperplasia. Therefore, it seems to be prudent to introduce the use of GnRH analogs for the treatment of BPH patients.

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How quickly does prostate cancer spread?

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Prostate cancer cell invasion occurs through two sequential steps of cell displacement and cell invasion. This process is fast but requires the presence of a suitable extracellular matrix and cell adhesion molecules. This is a very dynamic process, especially at very early stages of cell invasion.

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How serious can prostate cancer be?

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Current guidelines and guidelines recommendations, based on current science on the molecular biology of prostate cancer, place a strong emphasis on curative intent, and treatment of patients with high-risk disease will continue to be a challenge during the foreseeable future. Treatment for prostate cancer must continue to address risks and benefits with reasonable caution, and consideration for quality of life.

Unverified Answer
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