STAMPEDE2: A randomised controlled platform trial testing treatments in metastatic hormone sensitive prostate cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University College London

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04], Diseases [C] - Male Urogenital Diseases [C12]

Decision date (initial)

2026-02-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Cancer Research UK · Advanced Accelerator Applications (ADACAP) / Novartis

External identifiers

EU CT number

2025-522145-21-00

ClinicalTrials.gov

NCT06320067

ISRCTN

ISRCTN66357938

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

The primary objectives of each comparison are to test:
1) Whether survival and/or cancer outcomes can be improved by the addition of the research treatments to SoC in men with metastatic prostate cancer and starting long-term androgen deprivation therapy.

Secondary objectives 1

1. Key secondary objectives of each comparison are to test: 2) The toxicity and compliance with the research arms. 3) Whether Quality of Life is altered with the addition of research therapies. 4) Whether treatment pathway cost and resource use are altered with the addition of research therapies.

Conditions and MedDRA coding

Metastatic hormone sensitive prostate cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. I. At least 18 years old.
2. II. Histological confirmation of prostate adenocarcinoma or a strong clinical suspicion of prostate cancer with a plan to confirm the diagnosis formally before any future randomisation.
3. III. Confirmation of metastatic site(s) on CT/MRI and either bone or PET scan. Patients with metastatic disease meeting any of the following criteria are eligible: • Metastatic disease to the bone (in any distribution). • Non-regional lymph node metastases of any size or distribution. Lymph nodes that are only visible on PET will not be eligible as sites of metastasis. Note: If lymph nodes are the only site of metastases, then at least one must be at least 1.5cm in short axis AND outside of the pelvis. • Visceral metastases of any size or distribution.
4. IV. Clinical presentation is: A. de novo. OR B. relapsed with; (1) continuing hormone sensitivity in the opinion of the investigator, and; (2) all hormone treatments (e.g., ADT and ARPI) will have been completed ≥2 years prior to any future randomisation into any of the comparisons, and; (3) will have received ≤3 years total of ADT at the point of randomisation into any comparison. Note: the dates will be checked again at randomisation. It is the responsibility of the investigator to account for the time between registration and randomisation into any comparison.
5. V. Long-term androgen deprivation therapy (ADT) has started or there is an intention to start for a minimum of 2 years.
6. VI. WHO Performance Status 0-2 or, if WHO Performance Status 3, deemed to be due to metastatic burden and expected to improve with ADT. Note: Improvement to WHO status 0-2 will be checked again at randomisation into any subsequent comparison.
7. VII. Willing and able to comply with trial treatments.
8. VIII. Patient has signed informed consent form for registration into the STAMPEDE2 Trial platform.
9. *Listed above are the general inclusion criteria into the STAMPEDE2 platform, comparison specific eligibility criteria are listed in section 4 of the Master Protocol

Exclusion criteria 5

1. I. Clinically and pathologically overt small cell carcinoma.
2. II. Metastatic brain disease or leptomeningeal disease.
3. III. Any active malignancies (i.e., progressing or requiring any treatment in the previous 36 months) other than prostate cancer (except non-muscle invasive bladder cancer; non-melanomatous skin cancer or a malignancy that is considered cured with minimal risk of recurrence).
4. IV. Any other medical condition that in the investigator's opinion means the participant is unfit or unsuitable for long-term ADT or the trial treatments in the comparison for which they are being considered.
5. *Listed above are the general exclusion criteria into the STAMPEDE2 platform, comparison specific eligibility criteria are listed in section 4 of the Master Protocol

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. For both Comparisons S and P, the primary outcome is Overall Survival (OS) defined as time from randomisation to death from any cause.

Secondary endpoints 1

1. Failure-Free Survival (FFS), Radiographic Progression-Free-Survival (rPFS), Prostate cancer specific survival (PCSS), Safety, toxicity and compliance, Quality of life, Cost and resources.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University College London

Sponsor organisation

University College London

Address

90 High Holborn

City

London

Postcode

WC1V 6LJ

Country

United Kingdom

Scientific contact point

Organisation

University College London

Contact name

Sponsor Trial Team

Public contact point

Organisation

University College London

Contact name

Sponsor Trial Team

Locations

3 EU/EEA countries · 34 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 55 files

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

Application history

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