Neoadjuvant Androgen Deprivation Therapy Plus Abiraterone With or Without Apalutamide for High-Risk Prostate Cancer

NCT02789878 | Completed Phase 2 DMC

• 1 other identifier: NP 779/15
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized study to evaluate the efficacy and safety neoadjuvant androgen deprivation therapy with goserelin and abiraterone with or without apalutamide prior to radical prostatectomy for patients diagnosed with localized high-risk prostate cancer.

Conditions

Prostate Cancer

Keywords

Neoadjuvant therapy; High-risk Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Pathologic response

  To compare the rate of pathologic complete response (pCR) or pathologic near complete response (pnCR), defined as less than 0,5 cm of residual tumor in the prostatectomy specimen after neoadjuvant therapy.

  3 months

Secondary Outcomes (6)

• Residual cellularity rate

  3 months

• Pathologic downgrading

  3 months

• PSA decline rate

  3 months

• Rate of positive surgical margins

  3 months

• Rate of undetectable PSA

  12 months

Other Outcomes (2)

• Rate of Magnetic Resonance Image Downstaging after Neoadjuvant Therapy

  3 months

• Exploratory analysis to correlate tissue expression of PSA, CYP17, Ki67, and AR with pathologic response.

  3 months

Study Arms (2)

ADT and Abiraterone

EXPERIMENTAL

* Goserelin 10.8 mg, single dose, subcutaneously. * Abiraterone 1,000 mg, once daily, orally for 3 months. * Prednisone 5 mg, once daily, orally for 3 months.

Drug: Goserelin; Drug: Prednisone; Drug: Abiraterone

ADT, Abiraterone and Apalutamide

EXPERIMENTAL

* Goserelin 10.8 mg, single dose, subcutaneously. * Abiraterone 1,000 mg, once daily, orally for 3 months. * Prednisone 5 mg, once daily, orally for 3 months. * Apalutamide 240 mg, once daily, orally for 3 months.

Drug: Goserelin; Drug: Prednisone; Drug: Abiraterone; Drug: Apalutamide

Interventions

Goserelin DRUG

Androgen Deprivation Therapy

Also known as: ADT

ADT and Abiraterone; ADT, Abiraterone and Apalutamide

Prednisone DRUG

Corticosteroid

ADT and Abiraterone; ADT, Abiraterone and Apalutamide

Abiraterone DRUG

CYP17 inhibitor

Also known as: Zytiga

ADT and Abiraterone; ADT, Abiraterone and Apalutamide

Apalutamide DRUG

Androgen-receptor antagonist

Also known as: ARN-509

ADT, Abiraterone and Apalutamide

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic confirmed prostatic adenocarcinoma
• Non-castrate levels of testosterone (\> 150 ng/dL)
• High-risk localized prostate cancer, defined by either:
• Tumor stage T3 by digital rectal examination, or
• Primary tumor Gleason score ≥ 8, or
• PSA ≥ 20 ng/mL
• Willing to undergo prostatectomy as primary treatment for localized prostate cancer
• Adequate hematologic, renal and hepatic function:
• WBC \> 3000/uL
• Platelets \> 150,000/uL
• Creatinine \< 2 mg/dL
• Bilirubin \< 1.5 x upper limit of normal (ULN)
• AST/ALT \< 2 x ULN
• Karnofsky Performance Status (KPS) ≥ 80%
• Able to swallow the study drugs whole as tablets

You may not qualify if:

• Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
• Current or prior hormonal therapy, radiation therapy or chemotherapy for prostate cancer
• Evidence of metastatic disease (M1) on imaging studies
• Other prior malignancy less than or equal to 5 years prior to randomization with the exception of squamous or basal cell skin carcinoma
• Abnormal cardiac function as manifested by NYHA (New York Heart Association) class III or IV heart failure
• History of prior cardiac arrhythmia.
• Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead
• Janssen, LP: collaborator

Study Sites (1)

Instituto do Cancer do Estado de Sao Paulo

São Paulo, São Paulo, 01246-0000, Brazil

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Goserelin; Prednisone; abiraterone; Abiraterone Acetate; apalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Androstenes; Androstanes

Study Officials

• Diogo A Bastos, MD

  Instituto do Cancer do Estado de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 3, 2016
• Study Start: January 24, 2019
• Primary Completion: April 30, 2022
• Study Completion: August 1, 2022
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)