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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%
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%
Personality change
6%
Erectile dysfunction
6%
Headache
6%
Dysgeusia
6%
Dyspnea
6%
HbA1c increased
6%
Hypertriglyceridemia
6%
Insomnia
6%
Irritability
3%
Anxiety
3%
Atrial fibrillation
3%
Bruising
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
1,079 Previous Clinical Trials
340,603 Total Patients Enrolled
76 Trials studying Prostate Cancer
15,760 Patients Enrolled for Prostate Cancer
Janssen PharmaceuticaIndustry Sponsor
40 Previous Clinical Trials
9,173 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

Frequently Asked Questions

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

What are the requirements to take part in this clinical trial?

"This trial is looking for 345 patients that have prostate cancer and meet the following age criteria: 18 to 95 years old. In addition, participants must also meet at least one of the following unfavorable risk factors: pT3 or pT4, PSA ≥ 0.1 after radical prostatectomy (value w/in 3 months of registration) AND at least 1 unfavorable risk factor listed below., PSA > 0.5, PSA doubling time (DT) < 10 months, Negative margins, Persistent PSA after RP (PSA never dropped below 0.1 after RP), Local/regional recurrence on"

Answered by AI

Has the Apalutamide drug been cleared by the FDA?

"While there is some data supporting Apalutamide's safety, it lacks evidence of efficacy, giving it a score of 2."

Answered by AI

What are the unique aspects of this clinical trial?

"There are currently 467 active trials for Apalutamide in 68 countries and 2079 cities. The first trial was completed in 2000 by AstraZeneca. This initial study involved 600 people and reached Phase 3 approval. In the last 20 years, 821 total trials have been completed."

Answered by AI

In how many areas is this research being conducted?

"There are a total of 8 hospitals running this clinical trial. Some notable locations include University of California, San Francisco in San Francisco, MD Anderson Cancer Center in Houston, and Memorial Sloan Kettering Cancer Center in New york."

Answered by AI

If an elderly person meets all other requirements, are they able to participate in this experiment?

"As long as they are aged between 18 and 95 years old, patients meeting all other eligibility criteria can participate in this trial."

Answered by AI

How many people have been recruited for this clinical trial thus far?

"This study has already completed its recruitment process. The trial was first posted on November 24th, 2017 and the latest update was March 7th, 2022. Currently, there are 1366 other trials recruiting patients with prostate cancer and 467 for Apalutamide."

Answered by AI

What are the main uses for Apalutamide?

"Apalutamide has demonstrated efficacy in the treatment of thyroiditis, non-metastatic prostate cancer, and ulcerative colitis."

Answered by AI

Are volunteers still being accepted for this research project?

"Unfortunately, this study is not presently enrolling patients. Although, it's worth mentioning that the clinical trial was first posted on 11/24/2017 and was last edited on 3/7/2022. If you are interested in other studies, there are 1366 clinical trials actively recruiting patients with prostate cancer and 467 trials for Apalutamide recruiting patients right now."

Answered by AI

What is the research history of Apalutamide?

"Apalutamide was first researched in 2000 at Centre de Recherche Clinique du CHUS. In the two decades since, there have been 821 completed clinical trials and 467 that are still ongoing. A significant number of these active trials are based in San Francisco, California."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Randomized Phase II Study of Salvage XRT + ADT +/- Abiraterone and Apalutamide for Rising PSA After RP (FORMULA-509)
Paul Nguyen, MD 2017. "Randomized Phase II Study of Salvage XRT + ADT +/- Abiraterone and Apalutamide for Rising PSA After RP (FORMULA-509)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03141671.
~47 spots leftby Apr 2025
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