Quality-of-Life Assessment for Prostate Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, CA
Prostate Cancer+5 More
Quality-of-Life Assessment - Other
Eligibility
18+
Male
Eligible conditions
Prostate Cancer

Study Summary

This study is evaluating whether trametinib is effective in treating patients with hormone-resistant prostate cancer.

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Eligible Conditions

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

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Quality-of-Life Assessment will improve 2 primary outcomes, 11 secondary outcomes, and 1 other outcome in patients with Prostate Cancer. Measurement will happen over the course of At 12 weeks.

At 12 weeks
PSA response rate
Week 24
Change in markers of cell proliferation (Ki67) and apoptosis (p27), assessed by immunohistochemistry
Change in trametinib target engagement of MEK1/2 defined by the presence of p-ERK, assessed by immunohistochemistry
Month 30
Overall survival
Up to 24 weeks
Molecular correlates defined by gene expression, assessed using ribonucleic acid-sequencing, and mutational events, assessed using DNA exome-seq
Objective radiographic response rate according to RECIST guidelines
Response rate assessed by RECIST criteria
Time to radiographic progression
ctDNA genomic aberrations, assessed by exome sequencing
Up to 30 months
Durability of PSA response as measured by time to PSA progression as defined by PCWG2 guidelines
Incidence of adverse events, graded according to the Common Terminology Criteria for Adverse Events version 4.0
Maximal PSA response
Quality of life, assessed by FACT-P
Time to initiation of alternative anti-neoplastic therapy

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

Control
Treatment (trametinib)

This trial requires 14 total participants across 2 different treatment groups

This trial involves 2 different treatments. Quality-of-Life Assessment 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.

Treatment (trametinib)Patients receive trametinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 30 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 30 months for reporting.

Closest Location

UCLA / Jonsson Comprehensive Cancer Center - Los Angeles, CA

Eligibility Criteria

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

Mark “yes” if the following statements are true for you:
Absolute neutrophil count > 1,500/uL during screening evaluation
Platelet count > 100,000/uL during screening evaluation
Hemoglobin > 9 g/dL during screening evaluation
Willing and able to give informed consent
Histologically confirmed prostate cancer (not exclusive of adenocarcinoma)
mCRPC that has progressed on at least 1 therapy progression (defined as Prostate Cancer Working Group 2 [PCWG2] or at investigators' discretion) approved for treatment of mCRPC, one of which must include abiraterone acetate and/or enzalutamide
Metastatic tumor that has been biopsied
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Willing to undergo biopsy of a metastatic lesion at the time of progression
Patients must have ongoing therapy to maintain serum testosterone < 50 ng/dL

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

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The American Cancer Society estimates a total of 249,640 cases of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) will be diagnosed in 2022. Prostate cancer is the most common cause of death among men in the USA. In this paper, we will assess the risk of bladder cancer among men in the United States using cancer incidence and mortality rates.

Unverified Answer

What are the signs of prostate cancer?

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Prostate cancer may also cause symptoms such as difficulty urinating, frequent urination, bleeding with urination or sudden increase in frequency of urination. The most noticeable sign may be an enlarged lymph node in the groin area. The enlargement is usually felt on or near the outer side of the penis, usually along with some difficulty urinating and or painful erection. Other symptoms may include anemia or an irregular or fast heartbeat. These symptoms may cause trouble in urinating during the day or night, especially on exercising.

Unverified Answer

What causes prostate cancer?

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The primary cause of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) is unknown. It is likely to be due to a combination of multiple small changes to the cell of the prostate (rather than a single large change), many of which are genetic in nature. Tobacco smoking, a known factor, accounts for the most cases of prostate cancer.

Unverified Answer

What is prostate cancer?

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It is often considered the "silent thief". As with all cancers (and their treatment), it can be extremely dangerous for life, and it can be missed on many occasions, thus compromising the outcome. The term 'prostate cancer' comes from the Latin word ', meaning'(singular form of ""); a word that comes from the word'(singular form of ""),'' (Greek: ). In particular'means'(singular form of ""), which comes from "", (Greek: ), itself from "", (Greek: ) (Latin: ), meaning'(singular form of the suffix ""). Consequently, it means ', i.e.

Unverified Answer

What are common treatments for prostate cancer?

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Treatment of more than 10% of cases with adjuvant hormonal therapy has improved clinical outcomes. More recently, a range of targeted agents as well as agents with cytotoxicity have become available as adjuncts to radiotherapy. More than 7% of cases require active surveillance.

Unverified Answer

Can prostate cancer be cured?

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Prostate cancer can not currently be cured. It is not clear to what extent the treatment of metastatic disease is associated with a longer time interval or with an improved survival. A randomized comparison of treatments will not be possible because of the lack of adequate randomized controlled studies.

Unverified Answer

How quickly does prostate cancer spread?

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The data suggest that more than 15% of PSA-detected low-risk prostate cancer cases may have locally recurrent disease 2 yr later. Longer-term followup will determine the significance of early PSA data.

Unverified Answer

Has quality-of-life assessment proven to be more effective than a placebo?

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When the effect of a medical intervention proves to be worthwhile, patients who participate actively in the study may also choose to continue to receive the intervention in spite of less effective treatment. There was no statistically significant difference between the quality-of-life assessment and placebo groups, nor was there any improvement in patient's satisfaction with treatment over time.

Unverified Answer

What are the latest developments in quality-of-life assessment for therapeutic use?

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In a time where quality-of-life considerations have become established for medical treatments, a more inclusive measurement system is required. Although most of the health indicators and the health status constructs currently used to assess quality-of-life are applicable, they do not necessarily cover all aspects of health perceived to be important to a large proportion of the patient population. Furthermore, although the results of the EQ-5D are statistically significant (P < 0.001), they do not provide sufficient information for determining the value of a health state, for decisions regarding healthcare policy. There is an urgent need for new tools to assess health-related quality of life.

Unverified Answer

What is the latest research for prostate cancer?

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Men with high-grade prostate cancer have worse disease-specific survival than men having low-grade disease. In men undergoing therapy for prostate cancer, overall survival is worse than in men in watchful waiting groups. This may be explained by high-grade prostate cancer affecting more men than low-grade prostate cancer.

Unverified Answer

How serious can prostate cancer be?

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The outcomes of prostate cancer depend on the characteristics of the disease, but prostate cancer can be more dangerous depending on the time of diagnosis and the stage of the disease. The risk of PCa death seems to be influenced by the time of diagnosis and the level of the tumor. To improve patients survival it is essential to follow the most appropriate protocol of diagnostics at a specialized health care unit and to give more attention to the quality of treatment which should be implemented from the very beginning of the treatment in the same institution.

Unverified Answer

What is the average age someone gets prostate cancer?

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The mean age of diagnosis of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) increased significantly between 1968 and 2006 (from 71 years to 74 years), but the average age of diagnosis of prostate cancer has not change of the proportion of benign prostate disease in men (BPH). In a period when the incidence of prostate cancer decreased and when the average age of diagnosis of prostate cancer decreased, a proportion of men who were diagnosed by prostate biopsy had histology (core needle biopsy) confirming BPH. We report a new and unusual finding.

Unverified Answer
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