CLINICAL TRIAL

Abemaciclib 150 MG by mouth twice daily for Prostate Cancer

Recruiting · 18+ · Male · Birmingham, AL

This study is evaluating whether a drug may help reduce the risk of cancer returning in individuals who have already received radiation therapy.

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About the trial for Prostate Cancer

Eligible Conditions
Prostatic Neoplasms · Prostate Cancer

Treatment Groups

This trial involves 2 different treatments. Abemaciclib 150 MG By Mouth Twice Daily 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Abemaciclib 150 MG by mouth twice daily
DRUG
Radiation Therapy
RADIATION
Androgen deprivation therapy (ADT)
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2005
Completed Phase 3
~7080
Androgen deprivation therapy (ADT)
2013
Completed Phase 3
~1260

Eligibility

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

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Gleason 8, ≥ T2, any PSA
Prior treatment with systemic anti-cancer agents is not allowed.
ECOG PS=0 or 1.
Must have at least 1 target lesion.
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline to 24 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline to 24 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Abemaciclib 150 MG by mouth twice daily will improve 1 primary outcome and 2 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of Up to 3 months of treatment.

PSA declines prior to radiotherapy
UP TO 3 MONTHS OF TREATMENT
PSA declines prior to radiotherapy- calculated from nadir level prior to initiation of radiation therapy
Time to PSA Failure
BASELINE UP TO 24 MONTHS
Time to PSA failure will be analyzed using the Kaplan-Meier method
Clinical Response Rates
BASELINE TO 24 MONTHS
Clinical response rates will be assessed by percentage of patients who achieve the PSA nadir levels of < 0.5ng/ml on treatment

Who is running the study

Principal Investigator
E. Y.
Eddy Yang, Principal Investigator
University of Alabama at Birmingham

Patient Q & A Section

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

What are the signs of prostate cancer?

The current study presents a new set of signs of PCa with a large effect size that deserves more attention in both clinicians and researchers in order to improve the detection of prostate cancers.

Anonymous Patient Answer

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

About 14,400 men will have prostate cancer in their lifetimes, but only 2,700 will succumb to it. Prostate cancer is on the rise in the United States.

Anonymous Patient Answer

Can prostate cancer be cured?

There was no correlation between patient age (mean age: 51.5 yr) or biopsy Gleason score (mean 7.2) and prostate cancer-specific mortality; only the serum PSA level at diagnosis was a significant predictor of prostate cancer-specific mortality.

Anonymous Patient Answer

What causes prostate cancer?

Risk factors for prostate cancer include age, genetics and diet. However, these risks are not completely known, and prostate cancer is caused by random genetic mutations. The effects of aging on prostate cancer development are complex and not fully understood.

Anonymous Patient Answer

What is prostate cancer?

Prostate cancer is the third-most common cancer in men and accounts for 8% of all cancers in men. It is a disease of the male genital system. It is the second-leading cause of cancer mortality (cancer deaths) among men, following lung cancer. The prostate is an organ of the male reproductive system and forms part of the lower urinary tract.\n

Anonymous Patient Answer

What are common treatments for prostate cancer?

The treatment options for [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer), as listed by the National Comprehensive Cancer Network are summarized here, although additional treatment options exist for prostate cancer that has metastasized. The most commonly recommended treatment options for stage I-IIa prostate cancer are external-beam radiation therapy, hormonal therapy, and external beam radiation therapy combined with pelvic lymph node dissection. For those with either T3 or T4 prostate cancer there are a variety of suggested treatment options; however, it is recommended that patients discuss treatment options with their clinician. The overall 5-year survival rate for prostate cancer is 80-90%. The National Comprehensive Cancer Network lists several treatment options for those who have either locally recurrent prostate cancer or have metastatic disease.

Anonymous Patient Answer

How serious can prostate cancer be?

The seriousness of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) can vary among different patients and also among different geographic regions. The probability of dying from prostate cancer increases from 15% to 36% if the cancer escapes treatment during the early stage of the disease.

Anonymous Patient Answer

What does radiation therapy usually treat?

Radiation therapy is commonly given to men with LUTS or lower urinary tract cancers with the hope of improving symptoms. Yet some patients also have good outcomes with radiation therapy in terms of the risk of recurrence of their disease.

Anonymous Patient Answer

What is the survival rate for prostate cancer?

The survival for prostate cancer patients depends on the stage at diagnosis, aggressiveness of the disease, surgical resectability, age, Gleason score, seminal vesicle extension, race, and hormonal therapy. Prostate cancer is curable in about half of all patients and it seems that prostate cancer can be controlled in most patients when properly treated. Men with Stage T1 prostate cancer are at high risk for early death from the disease, whereas those with Stage T4 prostate cancer have a very high risk for death from metastatic disease. Women of all ages usually have a much higher mortality from prostate cancer.

Anonymous Patient Answer

How quickly does prostate cancer spread?

Despite our efforts, we were limited by the paucity of data on the long-term oncologic status of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) in this group of patients. However, the overall rate of metastasis was lower than in other series. This demonstrates a favorable outlook for men treated with radical prostatectomy alone.

Anonymous Patient Answer

Have there been other clinical trials involving radiation therapy?

The combination of surgery and radiation therapy in the management of prostate cancer has not had a role in the past and therefore should not be considered.

Anonymous Patient Answer

What is the average age someone gets prostate cancer?

The average age at diagnosis in the West is 67.8. In Australia the average age at diagnosis is 65.1, and in Scotland was 65.8 for men less than 70.

Anonymous Patient Answer
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