Pasritamig With Docetaxel vs Docetaxel in Metastatic Castration-resistant Prostate Cancer (mCRPC)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Janssen Cilag International

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

12 Mar 2026 → ongoing

Decision date (initial)

2026-03-10

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Pharmacokinetic, Safety, Pharmacodynamic, Efficacy

To determine whether treatment with pasritamig+docetaxel prolongs rPFS compared with docetaxel in participants with mCRPC

Conditions and MedDRA coding

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. 1. Have progressive metastatic castrate-resistant disease defined as at least one of the following: - PSA level ≥2 ng/mL that has increased on at least 2 successive occasions at least 1 week apart. - Progressive disease or new lesion(s) in the lymph nodes, bones, or viscera as defined by RECIST v1.1 and/or in bone scan per PCWG3 while on medical or surgical castration.
2. 2. Have progressed on at least 1 novel ARPI but received no more than 2 different ARPI (eg, abiraterone acetate, apalutamide, enzalutamide, darolutamide) for any stage of disease. Must have discontinued ARPI before randomization into the study.
3. 3. Have the following laboratory values during the screening period: - Hemoglobin ≥9.0 g/dL - Neutrophils ≥1.5 x 10^9/L - Platelets ≥100 x 10^9/L Note, transfusion or growth factor usage within 14 days of randomization is not allowed.

Exclusion criteria 3

1. 1. Received cytotoxic chemotherapy for prostate cancer (eg, docetaxel, cabazitaxel, mitoxantrone, etc).
2. 2. Received prior treatment for prostate cancer with: - CD3 redirector therapies or - Radiopharmaceutical agents or - Immunotherapy agents for prostate cancer (eg, sipuleucel-T, PD-1 inhibitors, T-cell redirectors, costimulatory agents, etc) or - PARP inhibitors (unless for BRCA1/2 mutations) or - Any other investigational agent for the treatment of mCRPC
3. 3. Patients with known BRCA 1/2 mutations (germline or somatic) who have not received treatment with a PARP inhibitor, unless not available or contraindicated.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. rPFS, measured as the time from randomization to the time of radiographic disease progression per PCWG3 and RECIST v1.1 as assessed by BICR on CT/MRI or bone scan, or death from any cause, whichever occurs first.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Comparator 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen Cilag International

Sponsor organisation

Janssen Cilag International

Address

Turnhoutseweg 30

City

Beerse

Postcode

2340

Country

Belgium

Scientific contact point

Organisation

Janssen Cilag International

Contact name

CTIS Point of Contact

Public contact point

Organisation

Janssen Cilag International

Contact name

CTIS Point of Contact

Third parties 5

Locations

5 EU/EEA countries · 32 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 68 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications