← Back to Search

Hormone Therapy

Antiandrogen Therapy + SBRT for Metastatic Prostate Cancer

Phase 2
Waitlist Available
Led By Nicholas Nickols
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Metastases must be amenable to treatment with SBRT
Presence of 1-5 visible metastases (by PSMA PET-CT)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to first rise in psa to 0.2 ng/ml, assessed up to 2 years
Awards & highlights

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.

Who is the study for?
Men with recurrent, metastatic prostate cancer after surgery are eligible for this trial if they have 1-5 visible metastases and no visceral spread. They must be fit enough for radiation therapy, have adequate blood counts and organ function, and not be on certain medications or have conditions that could cause seizures.Check my eligibility
What is being tested?
The trial is testing a combination of antiandrogen drugs (leuprolide, apalutamide, abiraterone acetate) with high-precision radiation therapy called SBRT to see if it's more effective in treating prostate cancer that has returned and spread.See study design
What are the potential side effects?
Possible side effects include fatigue, hot flashes from hormone therapy, digestive issues like nausea or diarrhea from the medication, skin reactions from radiation treatment, as well as potential impacts on liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer spread can be treated with targeted radiation.
Select...
I have 1 to 5 visible metastases detected by a special scan.
Select...
My pelvic lymph nodes are affected, but none are larger than 2 cm.
Select...
My cancer has spread to nearby tissues or lymph nodes.
Select...
I have been diagnosed with prostate cancer, not primarily small cell, but surgery was done.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My platelet count is at least 100,000 without transfusions in the last 3 months.
Select...
I am physically fit for targeted radiation therapy and hormone therapy.
Select...
My testosterone level was above 150 ng/dL before starting hormone therapy.
Select...
My cancer has not spread to my internal organs.
Select...
I stopped taking any medication that could increase my risk of seizures 4 weeks ago.
Select...
A biopsy of my cancer spread was attempted unless it was unsafe.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to first rise in psa to 0.2 ng/ml, assessed up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to first rise in psa to 0.2 ng/ml, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of patients achieving a serum prostate specific antigen (PSA) of < 0.05 ng/mL
Secondary outcome measures
Biomarker analysis
Health related quality of life: Functional Assessment of Cancer Therapy - Prostate (FACT-P) scale - patient questionnaire
Incidence of adverse events
+4 more
Other outcome measures
Changes in circulating immunophenotypes
Circulating tumor cells (CTCs) for predictors of response
Circulating tumor deoxyribonucleic acid (ctDNA) for predictors of response
+1 more

Side effects data

From 2021 Phase 2 trial • 86 Patients • NCT03279250
91%
Hot flashes
88%
Fatigue
62%
Anemia
47%
Hyperglycemia
41%
Dry skin
32%
Cholesterol high
29%
Rash
29%
Insomnia
26%
Dizziness
26%
TSH increased
26%
Hypertriglyceridemia
24%
Arthralgia
24%
Headache
21%
Lipase increase
21%
Memory impairment
15%
Hypertension
12%
AST increase
12%
Amylase increase
12%
White blood cell decrease
12%
Anxiety
12%
Dysgeusia
12%
Irritability
12%
Nausea
9%
ALT increase
9%
Alopecia
9%
Erectile dysfunction
9%
Hypothyrodism
6%
Paresthesia
6%
Bruising
6%
Weight loss
6%
Anorexia
6%
Cognitive disturbance
6%
Constipation
6%
HbA1c increased
6%
GERD
6%
Generalized Muscle Weakness
6%
Hypercalcemia
6%
Fall
6%
Lymphocyte count decrease
6%
Insulin increase
6%
LDH increase
6%
Vitamin D decrease
3%
Personality change
3%
Myalgia
3%
Syncope
3%
Dyspnea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A (LHRHa, Apalutamide)
Arm B (LHRHa, Apalutamide, Abiraterone Acetate)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (leuprolide, apalutamide, abiraterone acetate, SBRT)Experimental Treatment6 Interventions
Patients receive leuprolide SC on day 1, Patients receive a single dose of leuprolide SC on day 1 and apalutamide PO QD and abiraterone acetate PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. Beginning 2 months of initiation of ADT, patients also receive SBRT over 1, 3, or 5 fractions in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abiraterone Acetate
2015
Completed Phase 4
~1880
Apalutamide
2015
Completed Phase 2
~1510
Leuprolide Acetate
2002
Completed Phase 3
~1890
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
358 Previous Clinical Trials
26,048 Total Patients Enrolled
39 Trials studying Prostate Cancer
4,000 Patients Enrolled for Prostate Cancer
Janssen Inc.Industry Sponsor
23 Previous Clinical Trials
8,053 Total Patients Enrolled
1 Trials studying Prostate Cancer
315 Patients Enrolled for Prostate Cancer
Nicholas NickolsPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center

Media Library

Abiraterone Acetate (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03902951 — Phase 2
Prostate Cancer Research Study Groups: Treatment (leuprolide, apalutamide, abiraterone acetate, SBRT)
Prostate Cancer Clinical Trial 2023: Abiraterone Acetate Highlights & Side Effects. Trial Name: NCT03902951 — Phase 2
Abiraterone Acetate (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03902951 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~6 spots leftby Jan 2025