Apalutamide for Prostate Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
University of California San Francisco, San Francisco, CA
Prostate Cancer+1 More
Apalutamide - Drug
Eligibility
18+
Male
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug may help slow the growth of prostate cancer.

See full description

Eligible Conditions

  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Prostate Cancer

Study Objectives

This trial is evaluating whether Apalutamide will improve 2 primary outcomes and 12 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of 12 months.

12 months
Serum testosterone
36 months
PSA progression-free survival
PSA progression-free survival in both the intent-to-treat and testosterone-evaluable populations
PSA progression-free survival in the intent-to-treat population
PSA progression-free survival in the testosterone-evaluable population
6 years
Metastasis-Free Survival
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Overall Survival
Time to castration resistance
72 months
Quality of life EQ-5D-5L
Quality of life Expanded Prostate Cancer Index Composite (EPIC)
Quality of life Hot Flash Daily Interference Scale (HFRDIS)
Quality of life PROMIS Fatigue
Quality-adjusted survival

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Prostate Cancer

Trial Design

3 Treatment Groups

Arm A: Degarelix Monotherapy OR Leuprolide/Bicalutamide
1 of 3
Arm B: Degarelix/Apalutamide
1 of 3
Arm C: Degarelix/Apalutamide/Abiraterone/Prednisone
1 of 3
Active Control
Experimental Treatment

This trial requires 504 total participants across 3 different treatment groups

This trial involves 3 different treatments. Apalutamide is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Arm B: Degarelix/ApalutamidePatients will receive apalutamide and either degarelix OR leuprolide. Patients on this arm will NOT take bicalutamide at any point in the treatment course.
Arm C: Degarelix/Apalutamide/Abiraterone/PrednisonePatients will receive apalutamide and abiraterone acetate, in addition to either degarelix OR leuprolide. Patients on this arm will NOT take bicalutamide at any point in the treatment course.
Arm A: Degarelix Monotherapy OR Leuprolide/Bicalutamide
Drug
Patients will receive degarelix OR leuprolide with bicalutamide.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apalutamide
FDA approved
Abiraterone
FDA approved
Prednisone
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 years for reporting.

Closest Location

University of California San Francisco - San Francisco, CA

Eligibility Criteria

This trial is for male patients aged 18 and older. You must have received 1 prior treatment for Prostate Cancer or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
There is no definitive evidence of metastases on screening CT or MRI of the abdomen and pelvis, as judged by the investigator show original
Prior radical prostatectomy
Biochemically recurrent prostate cancer with PSA doubling time ≤ 9 months at the time of study entry. Calculation of PSA doubling time should include the use of all available PSA values obtained within past 6-12 months prior to randomization, with a minimum of 3 values separated by at least 2 weeks apart. PSA values obtained prior to therapeutic interventions (e.g. salvage radiation) will be excluded. PSA doubling time to be estimated using Memorial Sloan Kettering Cancer Center online calculator (https://www.mskcc.org/nomograms/prostate/psa-doubling-time)
Individuals who have undergone prior adjuvant radiation therapy or salvage radiation therapy are not candidates for radiation therapy based on a clinical assessment of the disease characteristics and patient co-morbidities. show original
Screening PSA > 0.5 ng/mL
Screening serum testosterone > 150 ng/dL
is recommended Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1 is recommended for patients with newly diagnosed multiple myeloma. show original
Age ≥ 18 years
is the most common malignant tumor in men in the United States show original
People taking medications that lower seizure thresholds must stop taking them four weeks before starting the first day of cycle one. show original

Patient Q&A Section

Can prostate cancer be cured?

"The data show that despite widespread belief, it is not possible to cure prostate cancer. However, it is also evident that the disease can be made to go into remission. To do this, patients need to be well informed and they need to be convinced that their life is not at risk, that the disease does not need to be repeated examination or to be treated with aggressive chemotherapy, and that the disease has a cure within their grasp if they choose to take its cure." - Anonymous Online Contributor

Unverified Answer

What is prostate cancer?

"In the past 5 years, the number of men diagnosed with prostatic cancer has risen to nearly 700,000 per year. Over 20,000 of these men have cancer that is localized, meaning that it has been halted by surgery, radiation therapy, or hormonal therapy. If cancers are found to have spread to lymph nodes or other areas of the body, and if they are found at the surface of the organ, the disease is considered "organ-confined". As prostate cancer has become more common, it is important for health-care providers to understand these factors that affect the course and outcome of disease." - Anonymous Online Contributor

Unverified Answer

What are the signs of prostate cancer?

"The symptom pattern of advanced prostate cancer is similar to that of low-risk patients with localized disease. The PSA is a good parameter to detect the disease." - Anonymous Online Contributor

Unverified Answer

What causes prostate cancer?

"We determined the role of environmental factors in the etiology of prostate cancer. Because of the limited sample size of this study and the limited study time window, this conclusion should be confirmed with the aid of larger studies and longer follow-up periods." - Anonymous Online Contributor

Unverified Answer

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

"Within the United States there is significant variation in rates of diagnosis of prostate cancer by race and by age. However, age remains the strongest predictor of prostate cancer-specific survival." - Anonymous Online Contributor

Unverified Answer

What are common treatments for prostate cancer?

"The American Academy of Family Physicians (AAFP) consensus guidelines recommend treating men with prostate cancer surgically after they have Gleason grade 3 or 4 disease, low urinary flow, high-grade Gleason tumors, and large tumor volumes, and in whom a curative therapy is appropriate. Appropriate therapy is indicated in all men with low, intermediate, and high Gleason grade stages, high tumor volumes, and low-flow obstruction." - Anonymous Online Contributor

Unverified Answer

What does apalutamide usually treat?

"Apalutrac therapy for prostate cancer is effective, especially in terms of PSA decline. In this retrospective study, patients receiving the drug in the first 3 months of treatment had a lower TTP compared to those treated afterwards." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving apalutamide?

"APA is being investigated in the clinic for a variety of uses and at different dosages. We are aware of 4 trials. These trials have been designed, and at the present time a number of subjects are available in each, with completion and/or reporting in progress." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for prostate cancer?

"In the UK, in contrast to other continents, where [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) has become more common, overall and cancer-specific survival rates show no significant improvement. The survival advantage in North America, particularly in African Americans, may be explained by survival differences by stage, and it is more likely that this survival advantage is due to earlier detection and, therefore, more effective referral to treatment as compared to other continents, where only a minority of patients are diagnosed with prostate cancer at an early stage." - Anonymous Online Contributor

Unverified Answer

Has apalutamide proven to be more effective than a placebo?

"In Japanese patients with [metastatic prostate cancer](https://www.withpower.com/clinical-trials/metastatic-prostate-cancer) or castration-resistant prostate cancer, apalutamide reduced the PSA level and significantly improved the time to progression following 12 weeks of treatment. Apalutamide has shown to be effective and well tolerated in Japanese patients with prostate cancer." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of prostate cancer?

"It should be emphasized that more research is required to clarify if the risk of prostate cancer can be partially or completely prevented by reducing the exposure to some risk factors that cause chronic inflammation and/or oxidative stress." - Anonymous Online Contributor

Unverified Answer

Is apalutamide safe for people?

"Compared with placebo, long-term apalutamide treatment is associated with similar rates of adverse events. There were no new or serious adverse effects reported in people taking apalutamide. This confirms that there are no risks that warrant the suspension of prescribing adjuvant apalutamide for patients diagnosed with localized prostate cancer." - Anonymous Online Contributor

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