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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

Must not have

Prior hormone therapy for prostate cancer excluding specific treatments

Prior chemotherapy, radiation therapy, or immunotherapy for prostate cancer

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

Approved for 30 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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

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I am eligible for prostate removal surgery as per my doctor's assessment.

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My prostate cancer is mainly adenocarcinoma, confirmed by a specialized review.

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My scans show no signs of cancer spread to other parts.

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I can carry out all my daily activities without help.

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I am a man aged 18 or older.

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I have had at least 6 core biopsies, with 3 showing cancer.

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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.

Exclusion Criteria

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

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I have had hormone therapy for prostate cancer, but not specific treatments.

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I have received treatments like chemotherapy, radiation, or immunotherapy for prostate cancer.

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I have a history of seizures or take medication that could cause them.

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I have severe liver problems.

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I do not have stomach or bowel problems that affect how I absorb medicine.

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I need to take more than 10 mg of prednisone daily for another health issue.

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I do not have any infections or conditions that prevent me from using steroids.

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I haven't taken azole drugs in the last two weeks.

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I have had issues with my pituitary or adrenal glands.

Timeline

Screening ~ 3 weeks3 visits

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Biochemical Progression Free Survival (bPFS) Rate at 3 Years Post RP [Part 2]

Combined pCR or MRD Rate [Part 1]

Secondary study objectives

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

anxiety

xerosis

elevated ALT

hematochezia

cough

elevated AST

xerostomia

general body aches

pruritis

nail discoloration

fever

anemia

epistaxis

infusion related reaction

neutropenia

neutropenic fever

gastrointestinal reflux

pain (bilateral legs)

mucositis

pain (joint);

anorexia

nail ridging

weight gain

hematuria

urinary tract obstruction

oral candidiasis

insomnia

depression

dyspnea

arthritis

pain (pelvis)

memory impairment

heartburn

100%

80%

60%

40%

20%

Study treatment Arm

Chemohormonal and Definitive Therapy After Prostatectomy

Awards & Highlights

Approved for 30 Other Conditions

This treatment demonstrated efficacy for 30 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

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

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

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