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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)
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 belowSelect...
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.
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 cancer has not spread to my internal organs.
Select...
A biopsy of my cancer spread was attempted unless it was unsafe.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to first rise in psa to 0.2 ng/ml, assessed up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to first rise in psa to 0.2 ng/ml, assessed up to 2 years
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 moreOther outcome measures
Changes in circulating immunophenotypes
Circulating tumor cells (CTCs) for predictors of response
Circulating tumor deoxyribonucleic acid (ctDNA) for predictors of response
+1 moreSide effects data
From 2021 Phase 2 trial • 86 Patients • NCT0327925074%
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%
Amylase increase
15%
Dizziness
12%
White blood cell decrease
12%
Memory impairment
12%
Constipation
12%
Lymphocyte count decrease
9%
Myalgia
9%
Paresthesia
9%
Weight loss
9%
Arthralgia
9%
Hypothyrodism
9%
LDH increase
6%
Personality change
6%
Headache
6%
Erectile dysfunction
6%
Dysgeusia
6%
Dyspnea
6%
HbA1c increased
6%
Hypertriglyceridemia
6%
Insomnia
6%
Irritability
3%
Bruising
3%
Anxiety
3%
Atrial fibrillation
3%
Anorexia
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
Abiraterone Acetate
2015
Completed Phase 4
~1880
Apalutamide
2015
Completed Phase 2
~3310
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
361 Previous Clinical Trials
27,720 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer spread can be treated with targeted radiation.I have a digestive condition that affects how my body absorbs food.I have 1 to 5 visible metastases detected by a special scan.My pelvic lymph nodes are affected, but none are larger than 2 cm.My cancer has spread to nearby tissues or lymph nodes.I have been diagnosed with prostate cancer, not primarily small cell, but surgery was done.I am fully active or restricted in physically strenuous activity but can do light work.I have inflammatory bowel disease or an active connective tissue disorder.My platelet count is at least 100,000 without transfusions in the last 3 months.I am physically fit for targeted radiation therapy and hormone therapy.My testosterone level was above 150 ng/dL before starting hormone therapy.I cannot have radiotherapy or hormone therapy.I am not taking strong medications that affect liver enzyme activity.My liver function is moderately to severely impaired.My cancer has not spread to my internal organs.I stopped taking any medication that could increase my risk of seizures 4 weeks ago.I take more than 10 mg of prednisone or similar daily for a chronic condition.I have a history of seizures or conditions that could lead to seizures.I haven't had serious heart issues or blood clots in the last 6 months.My blood pressure is currently not under control.I have no other cancers except for minor skin or bladder cancers.I am taking medication that is sensitive to changes in my body's enzyme levels.I have had radiation therapy in the pelvic area, but not for prostate cancer.A biopsy of my cancer spread was attempted unless it was unsafe.My prostate cancer is primarily small cell or has neuroendocrine features.I do not have an active infection like HIV or hepatitis.I have signs of pressure on my spinal cord.I have had cancer in my pelvic area before.My cancer has spread to my internal organs.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (leuprolide, apalutamide, abiraterone acetate, SBRT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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