Trials Sponsors Conditions Drugs Pricing

Conditions

Patients with locally advanced T4 high risk prostate cancer

Outcome Measures

Primary Outcomes (1)

The prim endpoint of this study is the proportion of pat. with operability - as assessed by MRI , transrectal ultrasound, and clinical examination (two experienced uro oncological surgeons) - upon inductive pre-prostatectomy treatment for a duration of up to 6 months. For patients who have not reached the PSA nadir after the 6-month period and are not considered as operable, the inductive therapy with apalutamide plus ADT can be expanded for a maximum of additiona

Secondary Outcomes (17)

Proportion of patients with pT0 (pCR) in prostatectomy specimens (complete pathological response)
Proportion of patients with negative margin specimen from prostatectomy according to the histology results after surgery
Proportion of patients with
Proportion of patients with post-prostatectomy complete biochemical remission (non-detectable serum PSA) 6 months after surgery without hormonal treatment
Proportion of patients with post-prostatectomy complications requiring surgical re-intervention (Clavien-Dindo IIIB complications, except for interventions aiming at hemostasis only) during the entire postprostatectomy period
+12 more secondary outcomes

Interventions

JNJ-56021927Type not reported

Registry intervention entries

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

Formulated product
JNJ-56021927
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.

JNJ-56021927
Named ingredient: apalutamide
View registry record

Eligibility Criteria

Sexmale

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

You may qualify if:

Male of 18 to 80 years of age, inclusive
Histologically confirmed adenocarcinoma of the prostate without complete neuroendocrine differentiation or small cell features
cT4 PCa, considered as primary inoperable because of a fixed mass defined by digital rectal examination, confirmed by advanced disease in MRI

Sponsors & Collaborators

Universitaet Des Saarlandes
Otherlead

Study Sites (2)

Universitaetsklinikum Aachen AöR

Aachen, 52074, Germany

Matthias Saar00492418036596 msaar@ukaachen.de

Universitaet Des Saarlandes

Homburg, 66421, Germany

Michael Stöckle004968411624700 michael.stoeckle@uks.eu

Central Study Contacts

Prof. Stöckle

004968411624700 michael.stoeckle@uks.eu

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

January 8, 2024

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2023-509837-37-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 04:28:26 UTC

Documents

D1_Protocol_2023-509837-37-00

You may not qualify if:

Presence of distant metastasis (clinical stage M1) after MRI, CT abdomen and bone scan Note: Patients with distant metastases only detectable in PSMA-PET/CTs are allowed to be included in the trial when conventional imaging (CT and bone scan) is negative for distant metastases
Pathological finding consistent with small cell, ductal, or complete neuroendocrine prostate cancer
Prior treatment with second generation anti-androgens
Prior treatment with CYP17 inhibitors
Prior treatment with systemic glucocorticoids ≤4 weeks prior to enrolment or patient expected to require long-term use of corticosteroids during the study
Use of 5-α reductase inhibitors (eg, dutasteride, finasteride) ≤4 weeks prior to enrolment
Major surgery ≤4 weeks prior to enrolment
Prior treatment with radiopharmaceutical agents
Prior chemotherapy for prostate cancer
History of any pelvic radiation
Bilateral orchiectomy
History or evidence of any of the following conditions: any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to enrolment; severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events, or clinically significant ventricular arrhythmias within 6 months; uncontrolled hypertension; history of seizure or convulsion; gastrointestinal disorder affecting absorption; active infection; and, any other condition that, in the opinion of the investigator, would impair the patient's ability to comply with study procedures
Presence of any of the following cardiologic criteria: a) Mean resting QTc >470 msec b) In patients with a history of risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval, the benefit-risk ratio including the potential for Torsade de pointes will be carefully assessed and patients will be excluded if the benefit-risk ratio is considered as unfavorable.
Active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding disorders secondary to hepatic dysfunction
Any active infection requiring systemic therapy
+3 more criteria

Inducta

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (17)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (17)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations