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Prostate CancerPhase 2NCT02789878

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

A Phase 2 study testing Goserelin, Prednisone and Abiraterone in people with Prostate Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Goserelin, Prednisone and Abiraterone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteBrazil
Study dates
24 Jan 2019to 1 Aug 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Instituto do Cancer do Estado de Sao Paulo

    São Paulo, São Paulo, 01246-0000

Other trials in Brazil

About this study

Official title: Phase II Study of Neoadjuvant Androgen Deprivation Therapy Plus Abiraterone With or Without Apalutamide for Patients With High-Risk Localized Prostate Cancer Prior to Radical Prostatectomy

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.

Read the detailed description

In the prostate specific antigen (PSA) era, about 15% to 20% of patients are diagnosed with high-risk localized disease and radical prostatectomy is a standard therapy for this subgroup of patients. However, despite best local therapy, about 30-60% of high-risk patients will eventually develop biochemical relapse and a significant proportion of these patients may progress with metastatic disease and die from prostate cancer. Currently, there is no data supporting the use of neoadjuvant therapy for patients with high-risk disease since studies failed to demonstrate clinically significant benefit with standard androgen deprivation therapy (ADT). Following improved outcomes in other malignancies with the use of neoadjuvant therapy with active drugs in the metastatic setting, there is a growing interest in evaluating new-generation androgen receptor (AR)-targeted therapy in earlier stages of prostate cancer. Therefore, the goal of this study is to evaluate the efficacy and safety of neoadjuvant therapy with ADT and abiraterone versus maximal androgen blockade using ADT, abiraterone and apalutamide for patients with high-risk localized prostate cancer.

Conditions
Prostate Cancer
Being tested
Goserelin, Prednisone, Abiraterone, Apalutamide
Keywords
Neoadjuvant therapy, High-risk Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GoserelinDrug

    Also called ADT

    Androgen Deprivation Therapy

  • PrednisoneDrug

    Corticosteroid

  • AbirateroneDrug

    Also called Zytiga

    CYP17 inhibitor

  • ApalutamideDrug

    Also called ARN-509

    Androgen-receptor antagonist

Study groups in NCT02789878
Study groupRoleWhat they receive
ADT and AbirateroneExperimental* 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.
Receives: Drug: Goserelin; Drug: Prednisone; Drug: Abiraterone
ADT, Abiraterone and ApalutamideExperimental* 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.
Receives: Drug: Goserelin; Drug: Prednisone; Drug: Abiraterone; Drug: Apalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months

Secondary outcomes (6)

  1. Residual cellularity rate

    To compare the rate of residual cellularity ≤ 30% in the prostatectomy specimen after neoadjuvant therapy.

    Measured: 3 months

  2. Pathologic downgrading

    To compare the rate of pathologic downgrading to ≤ ypT2N0 in the prostatectomy specimen after neoadjuvant therapy.

    Measured: 3 months

  3. PSA decline rate

    To compare the rate of PSA decline ≥ 50% and 90% after 3 months of neoadjuvant therapy.

    Measured: 3 months

  4. Rate of positive surgical margins

    To compare the rate of positive surgical margins in the prostatectomy specimen after neoadjuvant therapy.

    Measured: 3 months

  5. Rate of undetectable PSA

    To compare the rate of patients with undetectable PSA 12 months after radical prostatectomy.

    Measured: 12 months

  6. Rate of Grade ≥ 3 CTCAE adverse events

    To compare the rate of CTCAE grade 3 or higher adverse events of the neoadjuvant therapy arms

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2016 (estimated)
  2. Study start24 Jan 2019
  3. Primary completion30 Apr 2022
  4. Study completion1 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02789878
Sponsor's protocol ID
NP 779/15
Status last verified
Sep 2022
First submitted
25 May 2016
Last updated
15 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nascimento BCG, Pedrenho R, Zandona PCE, Sanvido LV, Bessa Junior J, Miranda EP, Bastos DA, Cordeiro MD, Coelho R, Nahas WC, Hallak J, Mulhall JP, Gomes CM. Prospective study of endogenous testosterone recovery following neoadjuvant hormonal blockade and radical prostatectomy in high-risk prostate cancer patients. J Sex Med. 2025 Sep 4;22(9):1554-1563. doi: 10.1093/jsxmed/qdaf164.

    PubMed 40693904

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Goserelin, Prednisone and Abiraterone in people with Prostate Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic response (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02789878, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.

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