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Hormone Therapy

ADT + Radiation +/- Abiraterone & Apalutamide for Prostate Cancer

Phase 2
Waitlist Available
Led By Paul Nguyen, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
PSA ≥ 0.1 after radical prostatectomy within 3 months of registration and at least 1 unfavorable risk factor
Age between 18 and 95 at the time of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing two different combinations of ADT and radiation to see which is better at treating PSA rise after radical prostatectomy.

Who is the study for?
Men aged 18-95 with prostate cancer who've had surgery but now have rising PSA levels. They must have a Gleason score of 8-10, fast PSA doubling time, and good organ function. Men must agree to use contraception and not donate sperm during the study.Check my eligibility
What is being tested?
The trial is testing two ADT combinations with radiation for prostate cancer patients post-surgery with rising PSA. It's seeing if adding Abiraterone and Apalutamide to standard treatment offers better outcomes.See study design
What are the potential side effects?
Possible side effects include hot flashes, fatigue, joint pain, high blood pressure, liver issues from Abiraterone/Prednisone; seizures or rash from Apalutamide; skin irritation from radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My PSA level is 0.1 or higher after prostate surgery, and I have at least one risk factor.
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I am between 18 and 95 years old.
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My prostate cancer diagnosis was confirmed through a tissue examination.
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I am eligible for additional radiation and hormone therapy.
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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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
PSA Progression Free Survival
Secondary outcome measures
Cardiovascular events consisting of myocardial infarction
Cause Specific Survival
Metastasis Free Survival on conventional imaging or pathologically (MFS)
+6 more

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%
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

2Treatment groups
Experimental Treatment
Group I: GnRH+Abiraterone+Apalutamide+PrednisoneExperimental Treatment5 Interventions
GnRH agonist injection monthly or every 3 months for 6 months Abiraterone acetate by mouth once/day for 6 months Prednisone by mouth once/day for 6 months Apalutamide by mouth once/day for 6 months Salvage radiation (starting 4-10 weeks after initiation of ADT)
Group II: GnRH + BicalutamideExperimental Treatment3 Interventions
GnRH agonist injection monthly or every 3 months for 6 months Bicalutamide by mouth once/day for 6 months Salvage radiation (starting 4-10 weeks after initiation of ADT)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apalutamide
2015
Completed Phase 2
~3310
GnRH
2017
Completed Phase 2
~320
Bicalutamide
2003
Completed Phase 3
~5330
Abiraterone
2012
Completed Phase 4
~2830
Prednisone
2014
Completed Phase 4
~2370

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,080 Previous Clinical Trials
340,585 Total Patients Enrolled
76 Trials studying Prostate Cancer
15,760 Patients Enrolled for Prostate Cancer
Janssen PharmaceuticaIndustry Sponsor
40 Previous Clinical Trials
9,121 Total Patients Enrolled
1 Trials studying Prostate Cancer
490 Patients Enrolled for Prostate Cancer
Paul Nguyen, MDPrincipal InvestigatorBrigham and Women's Hospital/Dana-Farber Cancer Institute
1 Previous Clinical Trials
21 Total Patients Enrolled

Media Library

Bicalutamide (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03141671 — Phase 2
Prostate Cancer Research Study Groups: GnRH + Bicalutamide, GnRH+Abiraterone+Apalutamide+Prednisone
Prostate Cancer Clinical Trial 2023: Bicalutamide Highlights & Side Effects. Trial Name: NCT03141671 — Phase 2
Bicalutamide (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03141671 — Phase 2
~39 spots leftby Apr 2025
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