← Back to Search

Neoadjuvant and Adjuvant Abiraterone + Apalutamide for Prostate Cancer

Phase 2
Waitlist Available
Led By Mary-Ellen Taplin, 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
Participants must be candidates for RP and considered surgically resectable by urologic evaluation
Histologically confirmed adenocarcinoma of the prostate without histological variants comprising >50% of the sample as determined by academic center central review
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed on day 1 of each cycle (1 cycle=28 +/- 2 days), up to 6 months from the initiation of neoadjuvant therapy.
Awards & highlights

Study Summary

This trial is testing whether androgen deprivation before surgery can improve pathologic response and biomarkers in localized prostate cancer.

Who is the study for?
Men over 18 with confirmed prostate adenocarcinoma, eligible for surgery, and no metastatic disease. They must have a Gleason score of at least 7 or higher PSA/T3 disease, good organ/marrow function, and agree to use contraception. Excluded if they've had prior hormone therapy for prostate cancer (except certain inhibitors), severe liver impairment, conditions requiring high-dose steroids, or significant cardiovascular issues.Check my eligibility
What is being tested?
The trial is testing the combination of Abiraterone Acetate and Apalutamide with Leuprolide and Prednisone in men undergoing prostatectomy for localized prostate cancer. It aims to see how this intense hormone treatment affects surgical outcomes and cancer markers.See study design
What are the potential side effects?
Possible side effects include hormonal imbalances leading to fatigue, hot flashes, joint pain; risk of heart problems; liver issues; increased blood sugar levels due to prednisone; potential impact on bone density; mood changes; and gastrointestinal disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am eligible for prostate removal surgery as per my doctor's assessment.
Select...
My prostate cancer is mainly adenocarcinoma, confirmed by a specialized review.
Select...
My scans show no signs of cancer spread to other parts.
Select...
I can carry out all my daily activities without help.
Select...
I am a man aged 18 or older.
Select...
I have had at least 6 core biopsies, with 3 showing cancer.
Select...
My prostate cancer has a Gleason score of 7 or higher, and my PSA is over 20 ng/dL or it's at stage T3.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed on day 1 of each cycle (1 cycle=28 +/- 2 days), up to 6 months from the initiation of neoadjuvant therapy.
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed on day 1 of each cycle (1 cycle=28 +/- 2 days), up to 6 months from the initiation of neoadjuvant therapy. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Biochemical Progression Free Survival (bPFS) Rate at 3 Years Post RP [Part 2]
Combined pCR or MRD Rate [Part 1]
Secondary outcome measures
Biochemical Progression Free Survival (bPFS) Rate at 2 Years Post RP [Part 2]
Biochemical Progression Free Survival (bPFS) Rate at 4 Years Post RP [Part 2]
Frequency of Positive Surgical Margins at RP (Part 1)
+12 more

Side effects data

From 2022 Phase 2 trial • 26 Patients • NCT03043807
81%
fatigue
38%
hot flashes
38%
neuropathy
19%
alopecia;
19%
dysgeusia
15%
hiccups
15%
nausea
15%
skin alterations
12%
diarrhea
12%
gastritis
12%
edema (lower extremity)
12%
rash
12%
constipation
8%
anxiety
8%
xerosis
4%
elevated ALT
4%
xerostomia
4%
hematochezia
4%
cough
4%
elevated AST
4%
general body aches
4%
pruritis
4%
nail discoloration
4%
fever
4%
anemia
4%
epistaxis
4%
infusion related reaction
4%
neutropenia
4%
neutropenic fever
4%
gastrointestinal reflux
4%
pain (bilateral legs)
4%
mucositis
4%
pain (joint);
4%
anorexia
4%
nail ridging
4%
weight gain
4%
hematuria
4%
urinary tract obstruction
4%
oral candidiasis
4%
insomnia
4%
depression
4%
dyspnea
4%
arthritis
4%
pain (pelvis)
4%
memory impairment
4%
heartburn
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemohormonal and Definitive Therapy After Prostatectomy

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2A: AAPL Adjuvant Therapy [Part 2]Experimental Treatment4 Interventions
Eligible Participants will be randomized to receive: AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 12 months
Group II: Arm 1B: APL Neoadjuvant Therapy [Part 1]Experimental Treatment3 Interventions
Eligible Participants will be randomized to receive: APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months
Group III: Arm 1A: AAPL Neoadjuvant Therapy [Part 1]Experimental Treatment4 Interventions
Eligible Participants will be randomized to receive: AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months Pts x weeks to RP
Group IV: Arm 2B: Observation [Part 2]Active Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apalutamide
FDA approved
Leuprolide
FDA approved
Prednisone
FDA approved
Abiraterone
FDA approved

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,072 Previous Clinical Trials
340,288 Total Patients Enrolled
76 Trials studying Prostate Cancer
15,997 Patients Enrolled for Prostate Cancer
Janssen Scientific Affairs, LLCIndustry Sponsor
157 Previous Clinical Trials
579,554 Total Patients Enrolled
10 Trials studying Prostate Cancer
1,225 Patients Enrolled for Prostate Cancer
Mary-Ellen Taplin, MDPrincipal InvestigatorDana-Farber Cancer Institute
15 Previous Clinical Trials
886 Total Patients Enrolled
13 Trials studying Prostate Cancer
759 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone Acetate Clinical Trial Eligibility Overview. Trial Name: NCT02903368 — Phase 2
Prostate Cancer Research Study Groups: Arm 1A: AAPL Neoadjuvant Therapy [Part 1], Arm 1B: APL Neoadjuvant Therapy [Part 1], Arm 2A: AAPL Adjuvant Therapy [Part 2], Arm 2B: Observation [Part 2]
Prostate Cancer Clinical Trial 2023: Abiraterone Acetate Highlights & Side Effects. Trial Name: NCT02903368 — Phase 2
Abiraterone Acetate 2023 Treatment Timeline for Medical Study. Trial Name: NCT02903368 — Phase 2

Frequently Asked Questions

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

Does the FDA recognize Abiraterone Acetate as a therapeutic option?

"Abiraterone acetate has been assigned a safety rating of 2, as the clinical trials have only provided some evidence to affirm its security, yet no data on efficacy."

Answered by AI

Are there any precedent studies which have studied the efficacy of Abiraterone Acetate?

"Abiraterone acetate was initially investigated in 2001 at Providence Cancer Center. Since then, a total of 798 trials have been completed and 433 studies are currently enlisting participants, with many being conducted out of La Jolla California."

Answered by AI

Are there still opportunities to join this research trial?

"At this moment, the recruitment process for this clinical trial has been put on pause. Initially posted in October 2016 and last updated in November 2022, no new candidates are being accepted at present. However, there is an abundance of other medical studies devoted to prostate cancer (1315) and Abiraterone acetate specifically (433)."

Answered by AI

What therapeutic purpose is Abiraterone Acetate employed for?

"Abiraterone acetate has proven to be effective in combating prostate cancer that is non-metastatic, ulcerative colitis and varicella-zoster virus acute retinal necrosis."

Answered by AI

How many people can partake in this medical experiment?

"This research project is no longer accepting new participants. The trial was first made visible on October 19th 2016 and has not been updated since November 2nd 2022. However, there are 1315 trials currently open to prostate cancer patients and 433 clinical studies recruiting for Abiraterone acetate treatment."

Answered by AI
~14 spots leftby Mar 2025