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New treatment option for High Risk Prostate Cancer
Official title 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
ClinicalTrials.gov ID: NCT06758882
What this study is testing
What is Apalutamide?
Apalutamide is an investigational medicine, being studied as a potential treatment for high risk prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80, men only
You may be able to join if
- ≥ 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...
- 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
You likely can't join if
- Distant metastasis based on conventional imaging (CT scan or bone scintigraphy). Nodal disease below the iliac bifurcation (clinical stage N1 at CT...
- 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...
- 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
See the full eligibility criteria
- ≥ 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; people must be willing and able to adhere to the...
- 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...
- 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 people with Gilbert's syndrome, if total bilirubin is \>1.5...
- 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
- 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
- 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...
- Human immunodeficiency virus-positive people 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Torino, To, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Torino, To, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.