A clinical study on SHR3680 combined with androgen deprived therapy (ADT) versus Bicalutamide combined with ADT in treatment of prostate cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Jiangsu Hengrui Pharmaceuticals Co. Ltd.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2024-12-03

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Jiangsu Hengrui Pharmaceuticals Co. Ltd.

External identifiers

EU CT number

2024-515194-10-00

EudraCT number

2018-003190-96

ClinicalTrials.gov

NCT03520478

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To determine whether SHR3680 combined with ADT is superior to Bicalutamide combined with ADT in terms of improving the radiological progression-free survival (rPFS) and overall survival (OS) in mHSPC subjects with high tumor load.

Secondary objectives 2

1. To evaluate and compare the time to progression in prostate specific antigen (PSA), time to the next bone related event, time to the start of the next anti-prostate cancer treatment and objective response rate (ORR) in SHR3680 combined with ADT versus Bicalutamide combined with ADT for treatment of mHSPC subjects with high tumor load
2. To evaluate and compare the safety of SHR3680 combined with ADT versus Bicalutamide combined with ADT in treatment of mHSPC subjects with high tumor load.

Conditions and MedDRA coding

Metastatic hormone-sensitive prostate cancer with high tumor load

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Age ≥ 18 years, male
2. Performance status ECOG Scores 0-1;
3. Histologically or cytologically confirmed adenocarcinoma of the prostate, and no neuroendocrine differentiation or small cell characteristics indicated;
4. High tumor load, i.e., the radiological examination meets at least one of the following conditions: 1) ≧4 bone metastatic foci in Tc-99m bone scanning (at least one focus not located in pelvis or spine); 2) visceral metastasis shown on CT/MRI (not including lymph nodes);
5. Plan to receive or maintain ADT during the study, i.e., to receive luteinizing hormone releasing hormone analogue (LHRHA) for continuous treatment (medical castration) or previous bilateral orchidectomy (surgical castration);

Exclusion criteria 5

1. Previous ADT, chemotherapy, surgery, external irradiation, brachytherapy, radiopharmaceuticals or experimental local treatment (including radiofrequency ablation, cryotherapy, high intensity focused ultrasound, etc.), with some exceptions.
2. Previous use or plan to use the 2nd generation androgen receptor antagonist (e.g., enzalutamide, ARN-509, ODM-201), ketoconazole, Abiraterone Acetate or other drugs under development inhibiting androgen synthesis (e.g., TAK-700) during study treatment for treatment of prostate cancer.
3. The subjects have received the following therapies within 4 weeks prior to C1D1:  5α-reductase inhibitor (e.g., Finasteride, dutasteride, etc.);  Estrogen, progesterone, androgen, steroid systemic therapy (except the temporary use for anti-allergic purpose);  Plant medicine with known anti-prostate cancer or PSA-lowering effect (e.g., Saw Palmetto);  Study treatment in other clinical trials.
4. Presence of tumor lesion in central nervous system through radiologically confirmed diagnosis.
5. Plan to receive any other antitumor therapies during this trial.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. rPFS,OS

Secondary endpoints 5

1. Time to PSA progression.
2. Time to the next bone related event (including fracture, spinal compression, radiotherapy or surgery for bones).
3. Time to the start of the next anti-prostate cancer treatment.
4. ORR
5. Safety endpoint.

Investigational products

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

Test 2

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Jiangsu Hengrui Pharmaceuticals Co. Ltd.

Sponsor organisation

Jiangsu Hengrui Pharmaceuticals Co. Ltd.

Address

7 Kunlunshan Road, Economic And Technological Development Zone Economic And Technological Development Zone

City

Lianyungang

Postcode

222047

Country

China

Scientific contact point

Organisation

Jiangsu Hengrui Pharmaceuticals Co. Ltd.

Contact name

Wenliang Wang

Public contact point

Organisation

Jiangsu Hengrui Pharmaceuticals Co. Ltd.

Contact name

Wenliang Wang

Locations

3 EU/EEA countries · 8 investigational sites

By country

Investigational sites

Results and documents

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

Documents 54 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