← 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)

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

No Placebo-Only Group

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

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a digestive condition that affects how my body absorbs food.

Select...

I have inflammatory bowel disease or an active connective tissue disorder.

Select...

I cannot have radiotherapy or hormone therapy.

Select...

My liver function is moderately to severely impaired.

Select...

I take more than 10 mg of prednisone or similar daily for a chronic condition.

Select...

I have a history of seizures or conditions that could lead to seizures.

Select...

I haven't had serious heart issues or blood clots in the last 6 months.

Select...

My blood pressure is currently not under control.

Select...

I have no other cancers except for minor skin or bladder cancers.

Select...

I have had radiation therapy in the pelvic area, but not for prostate cancer.

Select...

I do not have an active infection like HIV or hepatitis.

Select...

I have signs of pressure on my spinal cord.

Select...

I have had cancer in my pelvic area before.

Select...

My cancer has spread to my internal organs.

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

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

Myalgia

Paresthesia

Weight loss

Arthralgia

Hypothyrodism

LDH increase

Erectile dysfunction

Headache

Personality change

Dysgeusia

Dyspnea

HbA1c increased

Hypertriglyceridemia

Insomnia

Irritability

Anorexia

Atrial fibrillation

Anxiety

Bruising

Hypercalcemia

Dehydration

TSH increased

100%

80%

60%

40%

20%

Study treatment Arm

Arm B (LHRHa, Apalutamide, Abiraterone Acetate)

Arm A (LHRHa, Apalutamide)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Leuprolide Acetate

2002

Completed Phase 3

~1890

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~790