Docetaxel for Metastatic Castration Resistant Prostate Cancer (CRPC)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre), Kelowna, Canada
Metastatic Castration Resistant Prostate Cancer (CRPC)+1 More
Docetaxel - Drug
Eligibility
18+
Male
Eligible conditions
Select

Study Summary

This study is evaluating whether a blood test can help doctors decide which treatment to give patients with prostate cancer.

See full description

Eligible Conditions

  • Metastatic Castration Resistant Prostate Cancer (CRPC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Metastatic Castration Resistant Prostate Cancer (CRPC)

Study Objectives

This trial is evaluating whether Docetaxel will improve 1 primary outcome and 6 secondary outcomes in patients with Metastatic Castration Resistant Prostate Cancer (CRPC). Measurement will happen over the course of 3 months.

1 year
Correlation of specific ctDNA-based genomic alterations to treatment response
Objective response
PSA response rate
Progression free survival (PFS)
Second progression free survival (PFS2)
2 years
Overall survival (OS)
3 months
Clinical benefit rate (CBR)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Metastatic Castration Resistant Prostate Cancer (CRPC)

Trial Design

2 Treatment Groups

B: Clinician's Choice (CC)
1 of 2
A: Biomarker directed Therapy (BT)
1 of 2
Active Control
Experimental Treatment

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. Docetaxel 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.

A: Biomarker directed Therapy (BT)ctDNA fraction <2% receives enzalutamide, and ctDNA fraction ≥2% receives docetaxel until disease progression, then cross-over to the other therapy (e.g., enzalutamide to docetaxel, or docetaxel to enzalutamide).
B: Clinician's Choice (CC)Enzalutamide or docetaxel until disease progression, then cross-over to the other therapy (e.g., enzalutamide to docetaxel, or docetaxel to enzalutamide).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
FDA approved
Enzalutamide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Closest Location

BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre) - Kelowna, Canada

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:
The two-plus-two rule means that two new lesions on a bone scan must be confirmed on a subsequent bone scan at least eight weeks apart in order for a diagnosis of bone progression to be confirmed. show original
People who are 18 years or older are considered adults. show original
If you have had surgery to remove your testicles, or are currently taking a medication that blocks the effects of testosterone, your testosterone level must be 1.7 nmol/L or less at your screening visit in order to participate in this study show original
If there is evidence of metastatic disease on a bone scan or CT scan, this suggests that the cancer has spread to other parts of the body. show original
(if not screening, PSA at last known normal ≥2 years ago) A patient must have two rising PSA values from one week baseline measurements in order to be considered for PSA progression show original
This person has a very good performance status. show original
If the size of a person's soft tissue or visceral disease increases by at least 20% since they started treatment, or they develop any new lesions, then their disease is considered to be progressing. show original
to participate in a research study The person is able to provide understanding and agreement to taking part in a study show original
History of histologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine or small cell differentiation. If histology is not available, patients must have metastatic disease typical of prostate cancer (i.e., involving bone or pelvic lymph nodes or para-aortic lymph nodes) AND a serum concentration of PSA that is rising and >20ng/mL at the time prostate cancer was diagnosed clinically
for this study Consent for the analysis of tissue collected at diagnosis is mandatory for this study. show original

Patient Q&A Section

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

"The incidence and mortality rates per year were 0.1 and 0.2 per 1000 men in our state. The prevalence rate was higher, but still extremely low, averaging 0.065 man per 100,000 men. Over 100 million men are affected by prostate cancer in our population, and millions with this disease will develop and die without having ever been diagnosed." - Anonymous Online Contributor

Unverified Answer

What is prostate cancer?

"Men with benign prostate have larger prostate glands. The clinical relevance of prostate specific antigen screening and biopsy for all [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer)s and other forms of prostate cancer seems to be debatable. If we would take this into account, it is reasonable to recommend PSA screening for localized prostate cancers only in those men who have a higher risk of cancer, whereas in a general population (male) biopsy with PSA screening is debatable, too." - Anonymous Online Contributor

Unverified Answer

Can prostate cancer be cured?

"The current paradigm for cure of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) is inappropriate. It is based on unrealistic models of cancer development and progression and is incompatible with the fact that the majority of prostate cancer patients do not live long enough to be cured." - Anonymous Online Contributor

Unverified Answer

What causes prostate cancer?

"The risk of developing prostatic cancer is increased in men whose first degree relatives have had the disease. While not proven, there is suggestive evidence that hormonal factors are implicated in the development of prostate cancer." - Anonymous Online Contributor

Unverified Answer

What are common treatments for prostate cancer?

"Treating PCa involves treatment options including hormonal therapy, radiation therapies and chemotherapy. Often, treatments are selected based on the PSA test results. A good relationship between the patient and his/her oncologist is necessary to achieve successful treatment results." - Anonymous Online Contributor

Unverified Answer

What are the signs of prostate cancer?

"Prostate-specific antigen level (PSA) is the most commonly used staging tool to determine the extent of disease. Prostate-specific antigen level is the standard for screening and follow-up of patients who have been diagnosed with [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer)." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for prostate cancer?

"To improve survival rate of PCa patients, we recommend a multimodality treatment plan including an active surveillance program and adjuvant and salvage therapy when needed." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets prostate cancer?

"The average age of diagnosis in the current study is 60 years old which is consistent with other reported series. The average age of diagnosis for localized prostate cancer at diagnosis is 68 years old which is similar to other published series. An earlier age at diagnosis was related to an elevated risk for prostate cancer and lower rate of survival." - Anonymous Online Contributor

Unverified Answer

Does prostate cancer run in families?

"The study suggests a role for common genetic predisposition in the development of malignant transformation in the prostate. On the grounds of this study, genetic counseling and the search for genes predisposing prostate carcinoma are warranted in young men with a first degree relative affected by prostate cancer and the search for a familial prostate cancer phenotype in apparently sporadic cases." - Anonymous Online Contributor

Unverified Answer

What does docetaxel usually treat?

"There are many side effects and a large number of patients are discontinued after starting a docetaxel treatment. We did not find a way to predict which patients would suffer such side effects. We have to focus in the following side effects, but not all patients are afflicted by these side effects." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of docetaxel?

"The most common side effect of docetaxel is peripheral neuropathy, which may be due to a cumulative effect of taxanes. Peripheral neuropathy can be prevented by avoiding or mitigating other side effects of docetaxel. The side effects of docetaxel can be divided into general side effects, which are usually transient, and the hypersensitivity reactions which are seldom reported. In many cases hypersensitive reactions are triggered by the presence of docetaxel in the skin." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for prostate cancer?

"The following factors should be considered when making informed decisions about participation in clinical trials of investigational investigational agents: comorbidity, prior therapy and baseline characteristics (PSA level, age, baseline grade, presence of PSA-doubling)." - 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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