CLINICAL TRIAL

Ipatasertib for Prostate Cancer

1 Prior Treatment
Grade I
Metastatic
Waitlist Available · 18+ · Male · Chur, Switzerland

This study is evaluating whether a combination of drugs may help treat prostate cancer.

See full description

About the trial for Prostate Cancer

Eligible Conditions
Prostatic Neoplasms, Castration-Resistant · Prostatic Neoplasms · Castration Resistant Prostatic 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Ipatasertib
DRUG
Atezolizumab
DRUG
Docetaxel
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
Ipatasertib
Not yet FDA approved
Atezolizumab
FDA approved
Docetaxel
FDA approved

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Surgical or medical castration with testosterone serum level < 50 ng/dL (1.7 nM).
For participants treated with luteinizing hormone-releasing hormone analogs, initiation therapy >= 4 weeks prior to the first dose of study treatment and continued therapy throughout study treatment.
Progression of Prostate Cancer.
Receipt of at least one prior line of second generation AR-targeted therapy.
For participants in Part A of study: measurable visceral disease or measurable extrapelvic adenopathy per RECIST v1.1.
For participants in Part B of study: either measurable visceral disease or measurable extrapelvic adenopathy by RECIST v1.1 or bone lesions by bone scan, or both.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Ability to comply with the study protocol.
Adenocarcinoma of the prostate without small-cell or neuroendocrine features.
Metastatic disease that cannot be treated with curative intent.
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: Up to 35 months
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 35 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 35 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 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.

Percentage of Participants with Anti-Drug Antibodies (ADAs) to Atezolizumab
UP TO 35 MONTHS
UP TO 35 MONTHS
Serum Concentrations (ng/mL) of Atezolizumab at pre-specified timepoints
UP TO 35 MONTHS
UP TO 35 MONTHS
Overall Survival (OS) (median OS and landmark survival at 12, 18 and 24 months)
UP TO 35 MONTHS
UP TO 35 MONTHS
radiographic Progression-Free Survival (rPFS)
UP TO 35 MONTHS
Assessed according to the Prostate Cancer Working Group 3 (PCWG3) criteria
UP TO 35 MONTHS
Time to PSA Progression
UP TO 35 MONTHS
UP TO 35 MONTHS
Overall Response Rate (ORR) (In participants presenting with measurable visceral disease or measurable extrapelvic adenopathy at baseline)
UP TO 35 MONTHS
Defined as the proportion of participants with a complete response (CR) or partial response (PR) on two consecutive occasions >= 4 weeks apart, as determined by the Investigator according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumors, Version 1.1)
UP TO 35 MONTHS
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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.

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
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