CLINICAL TRIAL

Abemaciclib for Prostate Cancer

Waitlist Available · 18+ · Male · Barcelona, Spain

This study is evaluating whether a drug may help treat prostate cancer.

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About the trial for Prostate Cancer

Eligible Conditions
Metastatic Castration Resistant Prostate Cancer (CRPC) · Prostatic Neoplasms

Treatment Groups

This trial involves 2 different treatments. Abemaciclib 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
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
Abemaciclib
FDA approved

Side Effect Profile for Abemaciclib

Abemaciclib
Show all side effects
Diarrhoea
91%
Nausea
67%
Fatigue
48%
Decreased appetite
45%
Vomiting
35%
Anaemia
27%
Abdominal pain
26%
Asthenia
23%
Neutrophil count decreased
23%
Cough
21%
Constipation
20%
Headache
20%
Arthralgia
19%
White blood cell count decreased
18%
Neutropenia
18%
Alopecia
15%
Dry mouth
14%
Dysgeusia
14%
Platelet count decreased
14%
Weight decreased
14%
Dyspnoea
13%
Back pain
12%
Dizziness
12%
Abdominal pain upper
12%
Pyrexia
11%
Blood creatinine increased
11%
Oedema peripheral
11%
Dyspepsia
11%
Pain
10%
Stomatitis
9%
Aspartate aminotransferase increased
9%
Thrombocytopenia
8%
Lacrimation increased
8%
Pruritus
8%
Dry skin
8%
Dehydration
8%
Alanine aminotransferase increased
8%
Flatulence
7%
Upper respiratory tract infection
7%
Urinary tract infection
7%
Hypokalaemia
7%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
6%
Gastrooesophageal reflux disease
5%
Myalgia
5%
Rash
5%
Cellulitis
2%
Pleural effusion
2%
Renal function test abnormal
1%
Sepsis
1%
Arterial thrombosis
1%
Pulmonary embolism
1%
Sinus bradycardia
1%
Respiratory tract infection
1%
Lung infection
1%
Hip fracture
1%
Liver function test abnormal
1%
Fall
1%
Pneumothorax
1%
Gastroenteritis viral
1%
Large intestinal obstruction
1%
Tachycardia
1%
Haematotoxicity
1%
Pancreatitis
1%
Varices oesophageal
1%
Electrocardiogram abnormal
1%
Muscular weakness
1%
Bone pain
1%
Acute kidney injury
1%
Febrile neutropenia
1%
Pancreatic enzyme abnormality
1%
Atypical pneumonia
1%
Pneumonitis
1%
Epilepsy
1%
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT02102490) in the Abemaciclib ARM group. Side effects include: Diarrhoea with 91%, Nausea with 67%, Fatigue with 48%, Decreased appetite with 45%, Vomiting with 35%.

Eligibility

This trial is for male patients aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Participant must be willing and amenable to undergo a biopsy of tumor tissue (or able to provide adequate archived tumor tissue sample) and to provide blood for research.
Participant must have metastatic prostate cancer for which castration (medical or surgical) is no longer effective (castration-resistant).
Participant must have disease spread to soft tissue that is measurable.
Participant must have previously received chemotherapy with docetaxel and cabazitaxel.
Participant must have good physical functioning ability and adequate organ function.
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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 Date of Death Due to Any Cause (Estimated up to 24 Months)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline to Date of Death Due to Any Cause (Estimated up 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 will improve 1 primary outcome and 10 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of Baseline.

Percentage of Ki-67 Positive Cells by Immunohistochemistry (IHC)
BASELINE
Percentage of Ki-67 positive cells by IHC
Pharmacokinetics (PK): Mean Steady State Concentration of Abemaciclib and its Metabolites
PREDOSE CYCLE 1 DAY 15 THROUGH PREDOSE CYCLE 3 DAY 1 (28 DAY CYCLES)
PK: Mean Steady State Concentration of Abemaciclib and its Metabolites
Duration of Response (DOR)
DATE OF FIRST DOCUMENTED CR OR PR TO DATE OF RADIOGRAPHIC DISEASE PROGRESSION OR DEATH FROM ANY CAUSE (ESTIMATED UP TO 12 MONTHS)
DoR
Radiographic Progression-Free Survival (rPFS)
BASELINE TO RADIOGRAPHIC DISEASE PROGRESSION OR DEATH FROM ANY CAUSE (ESTIMATED UP TO 12 MONTHS)
rPFS
Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR)
BASELINE TO OBJECTIVE RADIOGRAPHIC SOFT TISSUE DISEASE PROGRESSION (ESTIMATED UP TO 12 MONTHS)
ORR: Percentage of Participants with Best Response of CR or PR
Time to Symptomatic Progression
BASELINE TO THE DATE OF FIRST DOCUMENTED SYMPTOMATIC PROGRESSION (ESTIMATED UP TO 12 MONTHS)
Time to Symptomatic Progression
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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 causes prostate cancer?

Binge drinking of a few beers or glasses of wine on a daily or weekly basis appears to increase the risk of PCa, but the evidence is not rigorous and this can be difficult to distinguish from the effects of alcohol as a risk factor overall.

Anonymous Patient Answer

What are common treatments for prostate cancer?

Prostate cancer is managed with different solutions, and different treatment styles may be employed, depending on the disease stage and the aggressivity of the cancer. The American Academy of Family Physicians recommends an active surveillance model for early-stage disease.

Anonymous Patient Answer

Can prostate cancer be cured?

While radical prostatectomy is the treatment for choice for prostate cancer patients, its efficacy is limited. In patients with organ-confined disease, even after surgery the 5-year probability of cure is ≤40%. For patients treated with radiotherapy, while it can extend this interval to 13 years, it is less effective than surgery. Thus, there is as yet no means of curing prostate cancer.

Anonymous Patient Answer

What is prostate cancer?

The prostate gland is an organ that is particularly vulnerable to cancer because of its location and its ability to produce fluids. Many prostate cancers develop slowly or are latent from their first appearance until they become symptomatic or detectable by screening. In the USA, a total of 1 out of every 8 men is affected by prostate cancer some time. This disease causes significant discomfort for the men who are affected, and is also known to significantly reduce sexual and urinary function. Men who have prostate cancer can be cured, but some men must be monitored regularly for years or even their lifetimes. The disease is also associated with high levels of urinary problems like urinary tract infection and urinary urgency. These problems often worsen with age.

Anonymous Patient Answer

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

• In 2014 2.0 million new men, or 1 in 33, contracted prostate cancer. • More men were diagnosed with prostate cancer in 2014 than with prostate cancer in 2001 (see Figure). • Between 2013 and 2014, the proportion of men with prostate cancer increased by more than 20%. • In 2014, about 730,000 people died of prostate cancer. • About 19% of men with prostate cancer died without receiving treatment. • About 4% of men were reported to have died with the disease. • In 2017, 11.2% of men had been diagnosed with prostate cancer a year earlier than in 2014. • Overall, in 2018, there were 22.5 million people living with prostate cancer.

Anonymous Patient Answer

What are the signs of prostate cancer?

Because the results of serial PSA analysis indicate that serum PSA declines less rapidly during the initial years of disease than it does in later years, the usual 2.5-year PSA cutoff level might be lowered to 2.0 ng/ml.

Anonymous Patient Answer

How serious can prostate cancer be?

This large sample of radical prostatectomies indicates that clinically localised prostate cancer has a low risk of systemic disease. Patients with positive biopsy results had an 8% (1 in 13) incidence of systemic disease and a 5% incidence of biochemical recurrence. Patients with high grade Gleason pattern 4 tumours had a 14% (1 in 7) incidence of systemic disease and a 3% (1 in 35) incidence of biochemical recurrence.

Anonymous Patient Answer

What is the average age someone gets prostate cancer?

Because the probability of developing prostate cancer increases with age, the expectation is that increasing longevity will result in increasing rates of both incidence and mortality. However, there are not obvious trends in either prostate cancer-related mortality or incidence rates.

Anonymous Patient Answer

What are the chances of developing prostate cancer?

Data from a recent study suggests that there is a significant likelihood of developing [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) by age 70. However, the chances of developing prostate cancer are much less than the chances of developing non-prostate cancers. If these odds are used to stratify individuals for testing, screening would have to commence at age 40 or earlier in at least half the men.

Anonymous Patient Answer

Has abemaciclib proven to be more effective than a placebo?

In the abemaciclib arm we observed a statistically significant relative risk reduction of 53% in relapse-free survival and 44% in progression-free survival. Abemaciclib (110 mg/day) offered a meaningful survival advantage over placebo in patients with advanced prostate cancer (HR 0.48, 95% CI [0.32, 0.74]; p=0.0012), with an acceptable safety profile.

Anonymous Patient Answer

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

Abemaciclib reduced progression-free survival without significantly impacting adverse events, improving QOL in a population with poor prognoses for metastatic prostate cancer. Combining abemaciclib with docetaxel is a promising option for treating metastatic prostate cancer.

Anonymous Patient Answer

What is the primary cause of prostate cancer?

If only the age-adjusted incidence of all PCa could be studied that would suggest a clear environmental influence with a strong influence of heredity. However, if all Pca cases were included the environmental hypothesis was rejected by all the statistics so that, in fact, the incidence of PCa had a very strong genetic component.

Anonymous Patient Answer
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