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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)
Must not have
Gastrointestinal disorder affecting absorption
Inflammatory bowel disease or active collagen vascular disease
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

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.
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.
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
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My cancer spread can be treated with targeted radiation.
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I have 1 to 5 visible metastases detected by a special scan.
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My cancer has spread to nearby tissues or lymph nodes.
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I have been diagnosed with prostate cancer, not primarily small cell, but surgery was done.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My platelet count is at least 100,000 without transfusions in the last 3 months.
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I am physically fit for targeted radiation therapy and hormone therapy.
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My cancer has not spread to my internal organs.
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A biopsy of my cancer spread was attempted unless it was unsafe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a digestive condition that affects how my body absorbs food.
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I have inflammatory bowel disease or an active connective tissue disorder.
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I cannot have radiotherapy or hormone therapy.
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My liver function is moderately to severely impaired.
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I take more than 10 mg of prednisone or similar daily for a chronic condition.
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I have a history of seizures or conditions that could lead to seizures.
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I haven't had serious heart issues or blood clots in the last 6 months.
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My blood pressure is currently not under control.
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I have no other cancers except for minor skin or bladder cancers.
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I have had radiation therapy in the pelvic area, but not for prostate cancer.
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I do not have an active infection like HIV or hepatitis.
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I have signs of pressure on my spinal cord.
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I have had cancer in my pelvic area before.
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My cancer has spread to my internal organs.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent of patients achieving a serum prostate specific antigen (PSA) of < 0.05 ng/mL
Secondary study objectives
Biomarker analysis
Health related quality of life: Functional Assessment of Cancer Therapy - Prostate (FACT-P) scale - patient questionnaire
Incidence of adverse events
+3 more
Other study objectives
Genomic and transcriptomic features present in metastatic tumors

Side effects data

From 2021 Phase 2 trial • 86 Patients • NCT03279250
74%
Hot flashes
71%
Fatigue
44%
Anemia
38%
Hyperglycemia
26%
AST increase
26%
Hypertension
26%
Lipase increase
24%
ALT increase
24%
Dry skin
21%
Rash
18%
ACTH increase
18%
Cholesterol high
15%
Dizziness
15%
Amylase increase
12%
Memory impairment
12%
White blood cell decrease
12%
Constipation
12%
Lymphocyte count decrease
9%
Myalgia
9%
Paresthesia
9%
Weight loss
9%
Arthralgia
9%
Hypothyrodism
9%
LDH increase
6%
Erectile dysfunction
6%
Headache
6%
Personality change
6%
Dysgeusia
6%
Dyspnea
6%
HbA1c increased
6%
Hypertriglyceridemia
6%
Insomnia
6%
Irritability
3%
Anorexia
3%
Atrial fibrillation
3%
Anxiety
3%
Bruising
3%
Hypercalcemia
3%
Dehydration
3%
TSH increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (LHRHa, Apalutamide, Abiraterone Acetate)
Arm A (LHRHa, Apalutamide)

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
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~790
Apalutamide
2015
Completed Phase 2
~4680
Leuprolide Acetate
2002
Completed Phase 3
~1890
Abiraterone Acetate
2015
Completed Phase 4
~1880

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
369 Previous Clinical Trials
29,401 Total Patients Enrolled
39 Trials studying Prostate Cancer
3,982 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
~2 spots leftby Jan 2025
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