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Apalutamide for Prostate Cancer

UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, CA
Prostate Cancer+3 More ConditionsApalutamide - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial is testing a combination of drugs and radiation to treat prostate cancer that has come back and spread. The drugs work in different ways to stop the growth of cancer cells, and the radiation is delivered with high precision to kill the tumor cells.

Eligible Conditions
  • Prostate Adenocarcinoma With Focal Neuroendocrine Differentiation
  • Stage IVB Prostate Cancer
  • Prostate Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
Treatment (darolutamide, leuprolide acetate)
1
Luteinizing Hormone Releasing Hormone
1
Sipuleucel-T without NHA

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Baseline to first rise in PSA to 0.2 ng/mL, assessed up to 2 years

Year 2
Time to biochemical progression
Year 2
Time to radiographic progression
Year 2
Time to initiation of alternative antineoplastic therapy
Year 2
Changes in circulating immunophenotypes
Year 2
Biomarker analysis
Circulating tumor cells (CTCs) for predictors of response
Circulating tumor deoxyribonucleic acid (ctDNA) for predictors of response
Genomic and transcriptomic features present in metastatic tumors
Health related quality of life: Functional Assessment of Cancer Therapy - Prostate (FACT-P) scale - patient questionnaire
Prostate cancer specific survival
Day 30
Incidence of adverse events
Month 6
Percent of patients achieving a serum prostate specific antigen (PSA) of < 0.05 ng/mL

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

2
Treatment (darolutamide, leuprolide acetate)
2
Luteinizing Hormone Releasing Hormone
2
Sipuleucel-T without NHA

Side Effects for

Arm B (LHRHa, Apalutamide, Abiraterone Acetate)
74%Hot flashes
71%Fatigue
44%Anemia
38%Hyperglycemia
26%Hypertension
26%AST increase
26%Lipase increase
24%ALT increase
24%Dry skin
21%Rash
18%Cholesterol high
18%ACTH increase
15%Amylase increase
15%Dizziness
12%White blood cell decrease
12%Constipation
12%Lymphocyte count decrease
12%Memory impairment
9%LDH increase
9%Myalgia
9%Arthralgia
9%Paresthesia
9%Weight loss
9%Hypothyrodism
6%Insomnia
6%Dyspnea
6%Hypertriglyceridemia
6%Irritability
6%Personality change
6%Headache
6%Dysgeusia
6%HbA1c increased
6%Erectile dysfunction
3%Anorexia
3%Bruising
3%Anxiety
3%TSH increased
3%Atrial fibrillation
3%Hypercalcemia
3%Dehydration
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT03279250) in the Arm B (LHRHa, Apalutamide, Abiraterone Acetate) ARM group. Side effects include: Hot flashes with 74%, Fatigue with 71%, Anemia with 44%, Hyperglycemia with 38%, Hypertension with 26%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

1 Treatment Group

Treatment (leuprolide, apalutamide, abiraterone acetate, SBRT)
1 of 1

Experimental Treatment

28 Total Participants · 1 Treatment Group

Primary Treatment: Apalutamide · No Placebo Group · Phase 2

Treatment (leuprolide, apalutamide, abiraterone acetate, SBRT)Experimental Group · 6 Interventions: Quality-of-Life Assessment, Stereotactic Body Radiation Therapy, Apalutamide, Leuprolide Acetate, Abiraterone Acetate, Questionnaire Administration · Intervention Types: Other, Radiation, Drug, Drug, Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2019
Completed Phase 2
~800
Apalutamide
FDA approved
Lidocaine
FDA approved
Abiraterone
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to first rise in psa to 0.2 ng/ml, assessed up to 2 years

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
342 Previous Clinical Trials
20,768 Total Patients Enrolled
37 Trials studying Prostate Cancer
3,890 Patients Enrolled for Prostate Cancer
Janssen Inc.Industry Sponsor
21 Previous Clinical Trials
8,008 Total Patients Enrolled
1 Trials studying Prostate Cancer
315 Patients Enrolled for Prostate Cancer
Nicholas NickolsPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
Amar KishanPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
4 Previous Clinical Trials
699 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be healthy enough to receive radiation therapy and androgen deprivation therapy for all visible sites of cancer spread.
Your cancer has spread to other parts of the body, but it can be treated with a specific type of radiation therapy called SBRT.
References

Frequently Asked Questions

What particular medical condition is Apalutamide commonly prescribed to treat?

"Apalutamide is often prescribed to tackle the symptoms of cervical syndrome, but it may also prove beneficial in managing minor burns, non-metastatic prostate cancer, and for patients who have undergone a transplant." - Anonymous Online Contributor

Unverified Answer

What health risks are associated with Apalutamide?

"Our team's assessment of Apalutamide's safety is a 2, as this drug has only been tested in Phase 2 trials. This affirms that there is some evidence for the medication's security even though its efficacy remains unconfirmed." - Anonymous Online Contributor

Unverified Answer

Are there any opportunities for participation in this clinical trial currently available?

"Clinicaltrials.gov confirms that this clinical trial is looking for participants, with the experiment first listed on March 17th 2021 and given an update as recently as August 9th 2022." - Anonymous Online Contributor

Unverified Answer

Are there any prior investigations into Apalutamide's efficacy?

"Currently, there are 274 separate studies assessing the efficacy of Apalutamide. Of those trials, 79 have entered into Phase 3 and 12185 investigative sites exist worldwide to evaluate this medication's benefits. In particular, many of these clinical trials are based in Duarte, California." - Anonymous Online Contributor

Unverified Answer

Are there limitations to the number of participants in this medical experiment?

"Indeed, the data available on clinicaltrials.gov reveals that this medical experiment is currently accepting participants. First posted on March 17th 2021, it was last modified on August 9th 2022 and 28 people are being sought from a single research clinic." - 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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