Ipatasertib for Prostate Cancer
This study is evaluating whether a combination of drugs may help treat prostate cancer.
See full descriptionAbout the trial for Prostate Cancer
Treatment Groups
This trial involves 2 different treatments. Ipatasertib 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 1 and are in the first stage of evaluation with people.
About The Treatment
Eligibility
This trial is for male patients aged 18 and older. You must have received 1 prior treatment for Prostate Cancer or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Ipatasertib will improve 3 primary outcomes and 8 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of Up to 35 months.
Patient Q & A Section
How many people get prostate cancer a year in the United States?
In 2019, around 17,000 new diagnoses of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) will be made in the US compared with 11,000 in 2006. The US is forecast to have the lowest prevalence of prostate cancer among world countries in 2019, although the highest mortality rate in 2019. In the United States, racial and ethnic disparities, low income, the number of male survivors of childhood cancer, and prostate-specific antigen tests are the strongest predictors of incidence and survival.
What are the signs of prostate cancer?
Symptoms such as swollen glands, abdominal pain, constipation and feeling unwell may indicate the possibility of prostate cancer. A sudden change in sexual habits may indicate prostate cancer. Fever is a non specific symptom of prostate cancer.
What is prostate cancer?
Prostate cancer remains an important cause of morbidity and decreased life expectancy in the United States. Prostate cancer is usually a slow evolving cancer, and the average PSA doubling time is 2-3 years. Most patients present with a very early diagnosis of organ confined disease, and the prostate cancer-related mortality rate is low. The prostate cancer overall survival rate is 96% 5 years after diagnosis. For all men, and especially those with high-grade organ-confined prostate cancer, life expectancies are significantly lower. While there have been advances in the treatment of prostate cancer, the best current model of care for advanced and metastatic disease is the combination of docetaxel chemotherapy, chemotherapy, and androgen ablation.
What are common treatments for prostate cancer?
Treatment of prostate cancer includes a variety of techniques, including surgical and non-surgical management; medical therapy; hormonal therapy; and radiation and non-radiation therapy. The effects of treatment are significant, yet the exact ways to treat prostate cancer can differ significantly when taken as a whole. Because of the many, varying types of treatments, we are not sure which treatments are most effective. The optimal treatment regimen is still unknown for certain, and further research is needed to establish the precise best treatment regimen for patients with prostate cancer.
Can prostate cancer be cured?
With aggressive therapies of prostate cancer, disease-specific death and disease-free survival can be substantially improved. However, many patients cannot be cured of prostate cancer, and this limitation of therapy must be recognized.
What causes prostate cancer?
There is no consensus, based on evidence to support a single or dual aetiology. We conclude that there are multiple contributing factors. The overall cancer risk appears to be the effect of cumulative exposure to a range of environmental and lifestyle factors. Furthermore, prostate cancer is extremely likely to occur spontaneously with a genetic predisposition, although environmental factors (such as tobacco smoking) substantially increase the risk of developing prostate cancer.
Is ipatasertib typically used in combination with any other treatments?
In a recent study, findings indicate that ipatasertib can be well combined with a number of different chemotherapy regimens, and that other chemotherapy combinations can be explored with ipatasertib as a partner drug to enhance the therapeutic benefit.
Have there been other clinical trials involving ipatasertib?
Ipatasertib has already been tested in phase III clinical trials in two different combinations. While the combination of ipatasertib and letrozole showed positive clinical results in first line setting and yielded positive results on the second line treatment in the phase 3 trial, the second phase 3 trial which investigated the first line use for high-risk patients did not show an overall benefit compared with letrozole monotherapy in this settings. The combination of ipatasertib and fulvestrant in 2nd and 3rd lines of treatment in the first phase 3 trial was discontinued due to insufficient activity, but a positive activity and safety profile was also reported by the investigator.
Has ipatasertib proven to be more effective than a placebo?
In the first two studies conducted specifically for the treatment of castration-resistant [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) (CRPC), ipatasertib significantly decreased prostate-specific antigen (PSA) levels and was significantly more effective than a placebo. The same trial results that were published in 2015 for the first-line treatment of CRPC were used in this study. In the first-line treatment of CRPC, ipatasertib decreased PSAD by 18.3% (vs. 4.1% in the placebo-controlled cohorts) and provided a statistically superior benefit: a 14.5% reduction in progression-free survival (PFS; hazard ratio [HR]: 0.53, 95% CI, 0.39 to 0.
Is ipatasertib safe for people?
Patients treated with ipatasertib showed adverse events consistent with reported dose-limiting side effects. Serious adverse events were uncommon with ipatasertib treatment. Adverse events of special concern were more prominent in patients treated in the safety in combination cohort.
What is the average age someone gets prostate cancer?
Results from a recent paper shows that overall [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) prevalence increases with age, even in early adulthood, while the rate of death caused by prostate cancer increases later in life. Results from a recent paper suggest that prostate cancer cases may be diagnosed at a younger age than the average age of diagnosis in other developed countries, possibly owing to earlier detection through prostate-specific antigen screening.
What are the common side effects of ipatasertib?
Common adverse effects of ipatasertib were mainly cutaneous and infusion reactions mostly occurring at the beginning of the treatment. Adverse reactions of renal function were rarely observed but in more severe cases necessitated treatment discontinuation and required treatment correction. On the basis of the results from this study, it may be anticipated that ipatasertib may not be suitable for patients having renal impairment.