AzTrials
AzTrials

High Risk Prostate CancerPhase 2STAPLENCT06758882

Surgical Treatment With or Without Apalutamide in Subjects With High Risk Prostate Cancer Who Are Candidates for Radical Prostatectomy and Staged as Oligometastatic With PSMA-PET

A Phase 2 study testing Apalutamide and Androgen receptor (AR) inhibitor in people with High Risk Prostate Cancer, run by Marco Oderda at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a phase 2, open-label, randomized study of adjuvant treatment in subjects with high-risk prostate cancer who are candidates for RP with PLND based on M0 status at conventional imaging, but staged as oligometastatic with PSMA PET/CT (performed as routine practice, according to recent evidence on high-risk… Read more about this study

Who is it for?
Ages 18 to 80 years, men only
Conditions the study is for
High Risk Prostate Cancer
What is being tested?
Apalutamide and Androgen receptor (AR) inhibitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteItaly
Study dates
25 Nov 2024to Jun 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • ≥ 18 years of age, < 80 years of age
  • Signed informed consent form (ICF) indicating that the subject understands the purpose and procedures required for the study and is willing to participate in the study; subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol (Section 4.3)
  • Histologically confirmed adenocarcinoma of the prostate
  • High-risk disease defined by a total Gleason Sum Score ≥ 4+4 (=Grade Groups [GG] 4-5)
  • Conventional imaging negative for metastases
  • Presence of low volume metastatic disease at pre-surgery PSMA PET/CT. The metastatic burden is classified according to the definition used in the CHARTEED trial applied to PSMA PET/CT, where high metastatic burden was defined as four or more bone metastases with one or more outside the vertebral bodies or pelvis, or visceral metastases, or both; all other assessable patients were considered to have low metastatic burden
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  • Candidate to RP with PLND
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  • Adequate organ function determined by the following laboratory values:
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and total bilirubin within normal limits, ie, ≤ the upper limit of normal [ULN] (note that in subjects with Gilbert's syndrome, if total bilirubin is >1.5 X ULN, measure direct and indirect bilirubin. If direct bilirubin is ≤1.5 X ULN, the subject may be eligible);
  • Serum creatinine <1.8 mg/dL;
  • Platelets ≥75.000/dL, without transfusion and/or growth factors within 56 days prior to RP;
  • Haemoglobin ≥11.0 g/dL, without transfusion and/or growth factors within 56 days prior to RP;
  • Able to receive ADT for at least 18 months, based on cardiovascular risk assessment and the investigator's assessment
  • Be able to swallow whole study drug tablets

Who cannot join

  • Distant metastasis based on conventional imaging (CT scan or bone scintigraphy). Nodal disease below the iliac bifurcation (clinical stage N1 at CT scan) is not an exclusion criterion.
  • Prior hormonal treatment (GnRHa, agonist or antagonist)
  • Prior bilateral orchiectomy
  • History of prior systemic or local therapy for prostate cancer, including pelvic radiation and whole gland or focal ablative modalities for prostate cancer
  • Use of any investigational agent ≤4 weeks prior to RP or any therapeutic procedure for prostate cancer at any time
  • Major surgery ≤4 weeks prior to RP
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  • Any of the following within 12 months prior to first dose of study drug: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease; uncomplicated deep vein thrombosis is not considered exclusionary
  • Human immunodeficiency virus-positive subjects with 1 or more of the following: (1) not receiving highly active antiretroviral therapy; (2) had a change in antiretroviral therapy within 6 months of the start of screening; (3) receiving antiretroviral therapy that may interfere with study drug (consult Sponsor for review of medication prior to enrolment); (4) CD4 count <350 at screening; (5) AIDS-defining opportunistic infection within 6 months of start of screening; (6) active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding disorders secondary to hepatic dysfunction
  • History of seizure; any condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness ≤1 year prior to RP); presence of brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect
  • Patients taking any prohibited medications (as reported in session 6.2 of the protocol, including medicinal products known to prolong the QT interval and/or drugs commonly known to cause torsade de pointes and/or drugs known to lower the seizure threshold within 4 weeks prior to RP) should not be included
  • Gastrointestinal conditions affecting absorption
  • Known or suspected contraindications or hypersensitivity to apalutamide, GnRHa or any of the components of the formulations
  • Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject
  • Active malignancies (ie, progressing or requiring treatment or treatment change in the last 24 months) other than prostate cancer. The only allowed exceptions are: non-muscle invasive bladder cancer (NMIBC); skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured; breast cancer (adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence); malignancy that is considered cured with minimal risk of recurrence.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marco Oderda, MD, PhD contact

00390116707682

marco.oderda@unito.it

Giorgio Calleris, MD contact

giorgio.calleris@unito.it

Italy1 site, 1 recruiting

  • Dept of Surgical Sciences - Urology, Molinette Hospital, University of Torino

    Torino, To, 10126

    Chiara Fiameni, 0116335530, chiara.fiameni@unito.it

    Recruiting

Other trials in Italy

About this study

This is a phase 2, open-label, randomized study of adjuvant treatment in subjects with high-risk prostate cancer who are candidates for RP with PLND based on M0 status at conventional imaging, but staged as oligometastatic with PSMA PET/CT (performed as routine practice, according to recent evidence on high-risk prostate cancer patients). Ninety-four subjects will receive apalutamide plus ADT or ADT alone after surgery. ADT is defined as medical castration (ie, gonadotropin-releasing hormone analogues [GnRHa, agonist or antagonist]). Subjects will be randomly assigned in a 1:1 ratio to receive apalutamide plus ADT or ADT alone.

Patients randomized to receive ADT + apalutamide or ADT alone will begin their adjuvant treatment 4 weeks (28 to 32 days) after surgery. A first dosage of PSA and testosterone will be performed just before starting adjuvant therapy but not before 28 days from surgery. Subsequently, PSA and testosterone dosage and clinical visits will be performed after 3 months from surgery and every 3 months until completion of study. PSMA PET/CT scan will be performed yearly, or in case of PSA progression. The Posttreatment Follow-up Phase will begin after 18 months of ADT and will last for 6 months, until study completion. Afterwards, patients will continue their follow-up according to the best clinical practice.

Being tested
Apalutamide, Androgen receptor (AR) inhibitor
Keywords
oligometastatic at PSMA PET/CT, apalutamide, radical prostatectomy, pelvic lymph node dissection, androgen deprivation therapy (ADT)

What participants receive

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

  • ApalutamideDrug

    administration of non steroid androgenic receptor inhibitors plus androgen deprivation therapy

  • Androgen receptor (AR) inhibitorDrug

    administration of androgen deprivation therapy

Study groups in NCT06758882
Study groupRoleWhat they receive
Interventional GroupExperimentalradical prostatectomy + apalutamide + androgen deprivation therapy
Receives: Drug: Apalutamide; Drug: Androgen receptor (AR) inhibitor
Control GroupActive comparatorradical prostatectomy + androgen deprivation therapy
Receives: Drug: Androgen receptor (AR) inhibitor

What is being measured

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

  1. Radiological progression-free survival (RPFS)

    the time from randomization to date of first PSMA PET/CT-based documentation of progressive disease (appearance of new lesions) or death, whichever occurred first. The RECIP criteria for progression will also be used for the analysis.

    Measured: from date of randomization to 24 months (6 months of follow-up after 18 months of treatment)

Secondary outcomes (1)

  1. Adverse events (AEs)

    Adverse events (AEs) will be graded according to the CTCAE version 5.0.

    Measured: from date of randomization to 24 months (6 months of follow-up after 18 months of treatment)

Timeline

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

  1. First posted6 Jan 2025
  2. Study start25 Nov 2024
  3. Primary completionJan 2026 (estimated)
  4. Study completionJun 2026 (estimated)

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
Model description
randomised trial
Masking
None (open label)
Enrolment
94 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06758882
Sponsor's protocol ID
40/2023
Other IDs
2022-002844-37
Acronym
STAPLE
Status last verified
Dec 2024
First submitted
19 Nov 2024
Last updated
6 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apalutamide and Androgen receptor (AR) inhibitor in people with High Risk Prostate Cancer, run by Marco Oderda at 1 site in Italy.

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 14 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: looking for participants now, as of the sponsor's last update on 6 Jan 2025. 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 Italy. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Marco Oderda, MD, PhD (00390116707682, marco.oderda@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiological progression-free survival (RPFS) (time frame: from date of randomization to 24 months (6 months of follow-up after 18 months of treatment)). 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 NCT06758882.

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 6 Jan 2025.

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