CLINICAL TRIAL

Apalutamide for Prostate Cancer

Recruiting · 18+ · Male · Los Angeles, CA

This study is evaluating whether antiandrogen therapy and SBRT work better than SBRT alone in treating patients with prostate cancer that has come back and has spread to other parts of the body.

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About the trial for Prostate Cancer

Eligible Conditions
Prostate Adenocarcinoma With Focal Neuroendocrine Differentiation · Metastatic Prostate Adenocarcinoma · Adenocarcinoma · Recurrent Prostate Carcinoma · Stage IVB Prostate Cancer AJCC v8 · Prostatic Neoplasms

Treatment Groups

This trial involves 2 different treatments. Apalutamide 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.
Abiraterone Acetate
DRUG
Apalutamide
DRUG
Quality-of-Life Assessment
OTHER
Leuprolide Acetate
DRUG
Questionnaire Administration
OTHER
Stereotactic Body Radiation Therapy
RADIATION
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
Abiraterone
FDA approved
Apalutamide
FDA approved
Lidocaine
FDA approved
Stereotactic Body Radiation Therapy
2016
Completed Phase 2
~560

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 5 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:
prior to initiation of treatment is associated with improved outcomes in patients with metastatic renal cell carcinoma (mRCC) Patients with metastatic renal cell carcinoma who have an adequate performance status (Eastern Cooperative Oncology Group [ECOG] 0-1) prior to initiating treatment are more likely to have improved outcomes. show original
should continue uninterrupted The patient must be physically fit in order to undergo SBRT to all visible sites of metastases show original
Visceral metastases are not allowed
: Patients with pelvic nodal metastases may have any number of them, but the largest one must be less than 2 cm. show original
If a biopsy of a metastasis is safe to perform, it should be attempted. show original
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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 first rise in PSA to 0.2 ng/mL, assessed up to 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline to first rise in PSA to 0.2 ng/mL, assessed up to 2 years.
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 Apalutamide will improve 1 primary outcome, 7 secondary outcomes, and 4 other outcomes in patients with Prostate Cancer. Measurement will happen over the course of Up to 30 days post treatment.

Incidence of adverse events
UP TO 30 DAYS POST TREATMENT
The intensity of clinical adverse events will be graded according to the Common Terminology Criteria for Adverse Events version (v) 4.0 (CTCAE) grading system in the toxicity categories.
Percent of patients achieving a serum prostate specific antigen (PSA) of < 0.05 ng/mL
UP TO 6 MONTHS POST TREATMENT
Will be summarized by count and percent along with the 95% confidence interval.
Time to radiographic progression
BASELINE TO TIME WHEN ANY IMAGING SHOWS NEW EVIDENCE OF METASTATIC DISEASE, ASSESSED UP TO 2 YEARS
Will be summarized using Kaplan-Meier method.
Time to initiation of alternative antineoplastic therapy
BASELINE TO TIME WHEN NEW ANTI-PROSTATE CANCER THERAPY IS INITIATED, ASSESSED UP TO 2 YEARS
Will be summarized using Kaplan-Meier method.
Changes in circulating immunophenotypes
BASELINE UP TO 2 YEARS POST TREATMENT
Prostate cancer specific survival
UP TO 2 YEARS POST TREATMENT
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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 are the signs of prostate cancer?

Symptoms such as frequent, painful or bloody urination, or an inconsistent stream during urination are suggestive of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer). Sudden onset of erectile dysfunction is also suggestive of prostate cancer. These symptoms usually occur long before prostate carcinoma is diagnosed, so it is likely that the prostate will undergo cancer.

Anonymous Patient Answer

What is prostate cancer?

Patients who are at substantial risk for developing prostate cancer will also carry a significant burden of psychological and physical burden and a need for social support. Men with prostate cancer face a multitude of challenges that range from psychological and social difficulties to treatment side effects.

Anonymous Patient Answer

Can prostate cancer be cured?

Though the cure rate depends on stage, most prostate cancers can be cured. However, a small number of men cannot be cured (around 10%) due to other factors being a contraindication.

Anonymous Patient Answer

What are common treatments for prostate cancer?

One of the more common treatments for [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) is androgen deprivation therapy. This therapy consists of medications that reduce the production of androgens in the body. In many patients with more-advanced cancer, the medication is or has become necessary even in the absence of symptoms. In addition to medication, one patient in eight was willing to undergo hormone therapy as treatment for their prostate cancer. On its own, the medication may decrease survival rates; however, patients in which these treatments are combined may experience more sustained responses to the treatment. Patients generally respond with varying degrees of success while undergoing a combination of treatments for prostate cancer. There have also been reports of possible positive effects of testosterone, as opposed to a castrate-like state.

Anonymous Patient Answer

What causes prostate cancer?

prostate cancer causes several symptoms and health care in men, and many of their symptoms can be caused by the physical changes of the disease rather than any specific illness. In a number of cases, prostate cancer may not be immediately noticeable, but, if detected, its treatment can greatly improve the quality of life in prostate cancer sufferers. Men are usually diagnosed after they have developed a large number of symptoms and their health care providers will try various means to get a full picture of their condition.

Anonymous Patient Answer

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

The National Surgical Quality Improvement Project estimates the incidence of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) per 10,000 of 20 in 2019, with the disease accounting for more than 25% of all surgeries in the United States and nearly 10% of all cancer deaths in the United States. Rates of prostate cancer are higher in low socioeconomic groups, although the cause of this is unclear. Most cases (~90%) of prostate cancer occur localized in the prostate gland. The 5-year survival rate is 85% following radical prostatectomy and 89% under androgen deprivation treatment. In a recent report, the National Comprehensive Cancer Network also indicates that 15.6% of new cases of prostate cancer were diagnosed following prostate biopsy, with an increasing proportion coming from low-risk tumors.

Anonymous Patient Answer

What is the latest research for prostate cancer?

The latest new evidence of the effectiveness of external beam radiation therapy in patients with T1/T2N0M0 [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) is supported by large, multi-institutional trials, particularly involving radical prostatectomy at the same institution where treatment (e.g. radical prostatectomy) is always practiced. As a result, external beam radiation therapy is recommended for all patients with localized prostate cancer, including those treated in this manner, in the NCCN guidelines for cancer of the prostate. Because the treatment of node-negative disease with external beam radiation therapy is not proven, treatment for node-negative disease with pelvic node dissection may be appropriate with patients for whom pelvic external beam radiation is indicated based on clinical stage or risk.

Anonymous Patient Answer

How quickly does prostate cancer spread?

It is recommended that staging and treatment for [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) be initiated following biopsy with a Gleason score of 7-8. In an intermediate-risk population, where a subset of patients have low PSA and prostate needle biopsy results that are close to 8s and/or 7, prostate-specific antigen screening by digital rectal examination, prostate biopsy, and possibly staging by prostate aspiration are sufficient for timely treatment.

Anonymous Patient Answer

Does prostate cancer run in families?

PCa runs in families; these families may be identified with improved accuracy by using a multimodal family screening approach that includes a PSA and risk-reducing biopsy in at-risk PCa families.

Anonymous Patient Answer

Is apalutamide typically used in combination with any other treatments?

Apalutamide therapy in prostate cancer has been mainly combined with standard treatments other than apalutamide. These include a broad range of chemotherapy drugs (5-FU and/or docetaxel), radiation therapies (ionizing radiation or proton beam therapies, brachytherapy or external beam irradiation), hormonal (androgen deprivation or estrogen deprivation) and immunotherapy (i.e. cytotoxic T lymphocyte-mediated therapy and/or antibodies specifically targeting the androgen receptor) agents and/or target other biological receptors including EGFR, HER2, HER3 and HER4 or GFR.

Anonymous Patient Answer

What is the average age someone gets prostate cancer?

A new study has estimated a median age of 67 for [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) in Australia. Considering that the median age for all cancer is 70 years old, it is reasonable to speculate that prostate cancer is becoming common at a later age.

Anonymous Patient Answer

Who should consider clinical trials for prostate cancer?

Findings from a recent study of two trials evaluating the same intervention (and placebo in one of these) are reassuring as to the efficacy and safety of a "second-line" treatment. The presence of a statistically significant difference in metastasis-free survival in either trial cannot be completely excluded. The question of whether such a trial could be conclusive is, however, in dispute.

Anonymous Patient Answer
See if you qualify for this trial
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