Trials Sponsors Conditions Drugs Pricing

Conditions

metastatic prostate cancer High Risk Prostate Cancer

Keywords

oligometastatic at PSMA PET/CTapalutamideradical prostatectomypelvic lymph node dissectionandrogen deprivation therapy (ADT)

Outcome Measures

Primary Outcomes (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.
from date of randomization to 24 months (6 months of follow-up after 18 months of treatment)

Secondary Outcomes (1)

Adverse events (AEs)
from date of randomization to 24 months (6 months of follow-up after 18 months of treatment)

Study Arms (2)

Interventional Group

EXPERIMENTAL

radical prostatectomy + apalutamide + androgen deprivation therapy

Drug: ApalutamideDrug: Androgen receptor (AR) inhibitor

Control Group

ACTIVE COMPARATOR

radical prostatectomy + androgen deprivation therapy

Drug: Androgen receptor (AR) inhibitor

Interventions

ApalutamideDrug

administration of non steroid androgenic receptor inhibitors plus androgen deprivation therapy

Interventional Group

Androgen receptor (AR) inhibitorDrug

administration of androgen deprivation therapy

Control GroupInterventional Group

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Erleada 60 mg film-coated tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Erleada 60 mg film-coated tablets
Named ingredient: apalutamide
View registry record

Eligibility Criteria

Age18 Years - 80 Years

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 participate in the study; subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol (Section 4.3)

Sponsors & Collaborators

Universita' Degli Studi Di Torino
Otherlead
Marco Oderda
Otherlead

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Study Sites (1)

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

Torino, To, 10126, Italy

RECRUITING

Chiara FiameniCONTACT0116335530 chiara.fiameni@unito.it

MeSH Terms

Interventions

apalutamideReceptors, Androgen

Intervention Hierarchy (Ancestors)

Receptors, SteroidReceptors, Cytoplasmic and NuclearProteinsAmino Acids, Peptides, and Proteins

Central Study Contacts

Marco Oderda, MD, PhD

CONTACT

00390116707682 marco.oderda@unito.it

Giorgio Calleris, MD

CONTACT

giorgio.calleris@unito.it

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

November 19, 2024

First Posted

January 6, 2025

Study Start

November 25, 2024

Actual (reported)

Primary Completion

January 2026

You may not qualify if:

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
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.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Interventional Group

Control Group

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Interventional Group

Control Group

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source records

Locations