Treatment for Castration Resistant Prostatic Cancer

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Vanderbilt-Ingram Cancer Center, Nashville, TN
Castration Resistant Prostatic Cancer+7 More
Eligibility
18+
Male
Eligible conditions
Select

Study Summary

This study is evaluating whether changes in the brain may be related to changes in cognitive function in men with prostate cancer.

See full description

Eligible Conditions

  • Castration Resistant Prostatic Cancer
  • Recurrent Prostate Carcinoma
  • Hormone Refractory Prostate Cancer
  • refractory, metastatic hormone-refractory Prostate cancer
  • Stage IV Prostate Cancer

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome, 5 secondary outcomes, and 2 other outcomes in patients with Castration Resistant Prostatic Cancer. Measurement will happen over the course of SNP chip assessment using blood drawn at baseline or 3 month visit.

Baseline and 3 months
Imaging assessed by MRI
Month 12
Cognitive function defined by overall Cogstate score and Cogstate module scores for each domain
Depression by Patient Health Questionnaire (PHQ-9)
Fatigue assessed using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT- Fatigue)
Instrumental activities of daily living by Texas Functional Living Scale
Quality of life assessed using European Organization for Research and Treatment of Cancer quality of life questionnaire-C30 (EORTC QLQ C-30)
Subjective measure of cognitive function by FACT-Cog
Month 3
SNPs associated with cognitive function

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

0 Treatment Group

This trial requires 100 total participants across 0 different treatment group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: measured at baseline, 3 months, 6 months, and 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly measured at baseline, 3 months, 6 months, and 12 months for reporting.

Closest Location

Vanderbilt-Ingram Cancer Center - Nashville, TN

Eligibility Criteria

This trial is for male patients aged 18 and older. You must have received newly diagnosed for Castration Resistant Prostatic Cancer or one of the other 7 conditions listed above. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Have diagnosis of prostate cancer and have received treatment with GnRH agonist or antagonist therapy for at least 1 month prior to enrollment.
Willing and able to complete survey questionnaires in English without assistance through the duration of the study. This stipulation is in place because not all of the proposed quality of life or cognitive tests are available or validated in other languages.
Age ≥ 18 years.
Ability to understand and the willingness to sign a written informed consent document written in English that is approved by an institutional review board.
Have either newly diagnosed metastatic hormone sensitive prostate cancer (mHSPC) or castration-resistant metastatic prostate cancer (mCRPC) and eligible to undergo treatment with abiraterone acetate (mHSPC or mCRPC) or enzalutamide (mCRPC)
Patients may have received the following prior AR directed therapy prior to enrollment: bicalutamide, ketoconazole. Prior to enrollment, patients may have received treatment with abiraterone acetate or enzalutamide for no more than 14 days before completing baseline studies.
Patients may have received chemotherapy for hormone-sensitive metastatic prostate cancer only, but it must not have lasted for more than 6 months. At least 12 months must have elapsed since completion of chemotherapy.
Patients may have received prior definitive radiation therapy or surgery. At least 60 days must have elapsed since completion of definitive radiation therapy or surgery and patient must have only grade 2 or less adverse effects at the time of registration. Enrollment during palliative radiation of ≤ 10 days, or radiation of ≤ 10 days during the duration of the study is allowed.
Patients must be able to take oral medication.

Patient Q&A Section

What are the signs of prostatic cancer, castration-resistant?

"Symptoms associated with castration-resistant [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) may not always present when the cancer is already at a detectable stage. In addition, most prostate cancer patients do not know they have the disease when present symptoms are not present. Screening prostate function and biochemical markers can help in the early detection of prostate cancer with a low risk of overtreatment." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of prostatic cancer, castration-resistant?

"A small minority of all invasive prostatic cancers are thought to be due to castration-resistant tumors. This subset is more aggressive, difficult to treat, and has poorer outcomes than the vast majority of cases that are thought to be of noncastrating origin." - Anonymous Online Contributor

Unverified Answer

What is prostatic cancer, castration-resistant?

"Prostatic cancer, castration-resistant is primarily an aggressive disease that has been associated with metastasis or death of prostate cancer patients at a mean of 10-14 months. However, patients with prostatic cancer, castration-resistant have not shown the same rate of recurrence as those with primary castration-resistant prostate cancer." - Anonymous Online Contributor

Unverified Answer

What are common treatments for prostatic cancer, castration-resistant?

"Given that castration is so important as an adjuvant to definitive therapy for prostate cancer, and that many prostate cancers are not responsive to castration therapy, further understanding of the molecular basis of castration resistance is important to guide novel drug development as well as to improve patient outcomes." - Anonymous Online Contributor

Unverified Answer

How many people get prostatic cancer, castration-resistant a year in the United States?

"The present study shows that only 0.1% of all men who were diagnosed with PC at age 40 years survived to age 74 years in all ethnic groups, and 0.7% to 0.9% survived to age 74 years in the black and Hispanic groups only. In the US in 1996, it is estimated that the incidence of PC was <4.0% of the population for men aged 40 years and >40% for men aged 74 years in all ethnic groups. Results from a recent clinical trial will have important implications if the goal of early diagnosis and treatment are to delay PC." - Anonymous Online Contributor

Unverified Answer

What causes prostatic cancer, castration-resistant?

"The cause of advanced prostatic cancer in the patient in this study is not clear, although factors which might have contributed are age, psychological stress, lack of exercise, and obesity. To elucidate this further, randomized trials are needed. Recent findings indicate that testosterone is at most of only minor importance for androgen-dependent cancers of the prostate gland. Moreover, the data are in disagreement with current pharmacological hypotheses in this regard." - Anonymous Online Contributor

Unverified Answer

Can prostatic cancer, castration-resistant be cured?

"The study has shown that when given chemotherapeutic treatment, castration-resistant prostate cancer cells can be killed in all individuals. For many patients, this allows a significant improvement in their lifespan. In the clinical setting at present, it can not yet be proposed that such treatment provides permanent cure or permanent disease ablation." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing prostatic cancer, castration-resistant?

"Castration resistant prostate cancer affects a significant number of patients, particularly older men. The risk of developing castration-resistant prostate cancer is significantly reduced in men aged 75 years or more, of shorter duration of castration, of shorter treatment span with or without radiation, and with or without estrogen receptor-negative disease. The 5-year failure rate is higher in patients with a Gleason score of 8 or more, but this is a fairly insensitive predictor of the long-term response to castration-resistant therapies." - Anonymous Online Contributor

Unverified Answer

What is the latest research for prostatic cancer, castration-resistant?

"The following is the latest research for castration-resistant prostatic cancer. Castration-resistant prostate cancer remains chemoresistant, because of the lack of circulating testosterone in a castrated patient." - Anonymous Online Contributor

Unverified Answer

Is treatment safe for people?

"Treatment for all endocrinologically disabled patients receiving hormone replacement therapy (HRT) is safe at present. A prospective cohort study is needed before changes to HRT regimens can be recommended." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets prostatic cancer, castration-resistant?

"Prostatic cancer is common in New Zealand. In Auckland in particular, prostatic cancer is more common than testicular cancer.[A review of the NZ cancer register indicated about 60 cases in 2006 of a tumor in the prostate (5 cases<65 yrs), and 30 cases in the testicular cancer group (13 ≤65 yrs ) (NZ cancer registry 2012;10).castration-resistant answer:" - Anonymous Online Contributor

Unverified Answer

Has treatment proven to be more effective than a placebo?

"There is little evidence supporting the use of hormonal therapy for [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) that is no longer responsive to prostatectomy, as compared with non-hormonal treatment using a placebo." - Anonymous Online Contributor

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