Treatment for Prostate Cancer

1
Effectiveness
2
Safety
Ben Taub General Hospital, Houston, TX
Prostate Cancer+2 More
Eligibility
18+
Male
Eligible conditions
Prostate Cancer

Study Summary

This study is evaluating whether the race and ethnicity of men with prostate cancer may affect how well standard treatments work.

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Eligible Conditions

  • Prostate Cancer
  • Prostatic Neoplasms
  • refractory, metastatic hormone-refractory Prostate cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 6 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of Measured at baseline.

Measured at baseline
Frequency of Potentially Deleterious Polymorphisms
Month 7
PSA Response Rate
Year 3
Progression Free Survival
Time to Initiation of Chemotherapy
Time to PSA Progression
Time to Subsequent Prostate Cancer Therapy
Month 7
Depth of PSA Response

Trial Safety

Safety Estimate

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

Trial Design

1 Treatment Groups

Control

This trial requires 130 total participants across 1 different treatment groups

This trial involves a single treatment. Treatment 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.

ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: treatment start until 7 months after start of adt
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly treatment start until 7 months after start of adt for reporting.

Closest Location

Ben Taub General Hospital - Houston, TX

Eligibility Criteria

This trial is for male patients aged 18 and older. You must have received newly diagnosed for Prostate Cancer or one of the other 2 conditions 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:
Some patients may be taking medications like denosumab or bisphosphonates that don't impact PSA levels. show original
Patients must not have any plans to receive any other experimental therapy while on the protocol treatment show original
Adenocarcinoma of the prostate must be histologically or cytologically proven in all patients prior to initiation of androgen deprivation therapy (ADT) show original
Patients who have been previously treated with neoadjuvant or adjuvant ADT, but have not had the treatment last for more than 36 months, are allowed to participate in the study show original
Patients with high-risk or extensive metastatic, hormone-sensitive prostate cancer who are deemed to be unsuitable candidates for docetaxel, or who have declined docetaxel therapy, are eligible for enrollment. show original
Patients must have a PSA level ≥ 10 ng/mL that was obtained within the past 90 days in order to be eligible for the study. show original
All patients must have a radiographic assessment, including a bone scan or PET scan, within 42 days prior to registration show original
Patients who have received surgery in the past 14 days are not eligible for enrollment. show original
Patients must have had no more than 42 days of prior castration (medical or surgical) for metastatic prostate cancer prior to starting abiraterone. The start date of medical castration is considered the day the patient first received an injection of a LHRH agonist/antagonist (or orchiectomy), not an oral antiandrogen. • If the method of castration was luteinizing hormone releasing hormone (LHRH) agonists (i.e., leuprolide or goserelin), the patient must be willing to continue the use of LHRH agonist and add Abiraterone + Prednisone treatment. • If the patient was on an antiandrogen (e.g. bicalutamide, flutamide), the patient must be willing to switch over to Abiraterone + Prednisone treatment. There is no limit on how many days a patient may have been on an antiandrogen (e.g. bicalutamide, flutamide) or a five alpha reductase inhibitor (e.g. finasteride or dutasteride) prior to going on study and no washout is required.
Before they can register, patients must have a complete physical examination and medical history. show original

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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Symptoms of prostate cancer can be eliminated with treatment. There is, however, no 100% cure. In addition to treatments discussed in this paper, and the treatment of secondary symptoms such as bone metastases, adjuvant radiation therapy, and androgen ablation, an open approach may be an alternative option, especially in cases where a definitive complete cure is a goal.

Unverified Answer

What are common treatments for prostate cancer?

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Prostate cancer is treated with a variety of treatments, including radical cryo-therapy, surgery, chemotherapy, external beam radiation therapy, hormonal therapies, intraoperative radiation therapy (TOMS), or a combination.

Unverified Answer

What is prostate cancer?

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If you were asked to categorize all prostate cancer in the US as either organ-confined, asymptomatic, or advanced prostate cancer, you would get very different answers to this question. Some would say all of these different types of disease exist, but are not true prostate cancer. You would probably say prostate cancer is any one of those categories or none. Most physicians who are experienced with prostate cancer would say there are three, not one, categories of prostate cancer: organ-confined, advanced, and metastatic. If you asked them what is an organ-confined or advanced or metastatic prostate cancer, they would all say what constitutes an organ-confined or advanced or metastatic prostate cancer is somewhat subjective.

Unverified Answer

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

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Around 250,000 men in the United States are diagnosed with [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) each year. It is the second most common cancer in men in the United States. While there is a gender difference in the incidence, there is no gender difference in mortality rates of prostate cancer.

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What are the signs of prostate cancer?

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Signs of prostate cancer include loss of bladder control, frequent urination, decreased erection, inability to void, and pain in the back, abdomen or rectum. Urinary tract infection can present with pain in the abdomen, rectal or bladder area. Any one or more of these may be signs of prostate cancer.

Unverified Answer

What causes prostate cancer?

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Many men will develop benign prostatic hyperplasia (BPH), a process involving the gradual enlargement of the prostate. Prostate cancer is a rare complication, though uncommon, of a BPH. BPH and BPH related cancer development are very common. As a matter of fact, the prevalence of prostate cancer increases with age.\nOn radiologic image, abnormal cells form in tissue, creating cancerous (cancerous) areas. Often over time, the cancerous areas become abnormal and develop into cancer—this is known as Cancer growth.\nAbout most prostate cancers, there is no set cause. In other words when it occurs, it usually appears. The only known cause of prostate cancer is inherited genetic mutation.

Unverified Answer

What does treatment usually treat?

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The present review of the literature did not support the current recommendations regarding the optimal management of small prostatic adenomas by the AUA in the absence of symptoms, given the fact that the majority of patients with small prostatic adenomas did not present with symptoms and/or the low rate of malignancy in these patients.

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Does prostate cancer run in families?

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In a recent study, findings are consistent with a role for inherited factors in the etiology of prostate cancer-specific mortality, and they suggest that more in-depth investigations into the heterogeneity of familial prostate cancer may contribute to a better understanding of prostate cancer etiology.

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Is treatment typically used in combination with any other treatments?

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We identified 10 therapies associated with other systemic treatments, mostly in high-risk cases. Overall, in the combination chemotherapy combination, overall response rate increased and time to treatment failure decreased with chemotherapy ± radiation vs chemotherapy ± radiation.

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What is the survival rate for prostate cancer?

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The disease seems to progress to more advanced stage (TNM) in men with higher Gleason scores. However, Gleason score does not change the survival rates.

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Does treatment improve quality of life for those with prostate cancer?

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The treatment of prostate cancer does seem to improve the QOL, particularly in the domains of sexual functioning and mobility, for patients for whom the disease is diagnosed at an early, curable or treatable stage.

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How does treatment work?

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Results from a recent paper indicate that the use of antiandrogen treatment could lead to significant clinical improvement. Because BPH often is associated with pain and voiding dysfunction, in addition to decreased QOL in men, we advise treatment of both elements. These elements are alleviated by using antiandrogen treatment.

Unverified Answer
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