EORTC-2238-GUCG: Improving impact of anti-androgen treatments on patient's daily life and their cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

European Organisation For Research And Treatment Of Cancer

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Male Urogenital Diseases [C12]

Trial duration

23 May 2025 → ongoing

Decision date (initial)

2025-04-01

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

EU grant (HORIZON 2022 RIA program)

External identifiers

EU CT number

2023-506817-23-01

ClinicalTrials.gov

NCT05974774

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The primary objective of this phase III trial is to establish the risk/benefit ratio of intermittent maximum androgen blockade (iMAB) vs. continuous MAB (cMAB) in mHSPC patients with a deep PSA response (PSA≤ 0.2 ng/mL) after 6 to 12 months with ADT and one of the registered ARpI.
The primary objective will be addressed through the following coprimary objectives:
1) To demonstrate among patients from the iMAB arm that the proportion of patients who do not restart their hormonal therapy within 1 year of interrupting their MAB therapy is ≥ 70% (feasibility endpoint)
2) To show that the overall survival (OS) from randomization using an iMAB regimen is non-inferior to continuous treatment (pertinence endpoint)

Conditions and MedDRA coding

Metastatic hormone naïve prostate cancer (mHNPC)

Regulatory references

Scientific advice from competent authorities

Federal Agency For Medicines And Health Products

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Patient treated with ADT (luteinizing hormone–releasing hormone (LHRH) agonist or antagonist) and an ARpI for mHNPC for 6-12 months and presenting with a PSA ≤ 0.2 ng/mL
2. Patients with synchronous or metachronous metastases, high volume or low volume/risk who fulfil the criteria can be included.
3. Before patient's enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations

Exclusion criteria 5

1. Patients with M1a on modern imaging technique (PET-Choline or -PSMA or Whole Body MRI) for whom radiation therapy and 2-3 years of hormone therapy is planned
2. Patients who underwent or will undergo a bilateral orchiectomy
3. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment for this trial
4. Patients who have received a systemic anti-prostate cancer treatment not approved by EMA together with MAB or a radical prostatectomy for M1 disease
5. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The co-primary endpoints in this trial are: 1) Proportion of patients who do not restart their hormonal therapy within 1 year of interrupting their MAB therapy 2) Overall survival (from randomization)

Secondary endpoints 15

1. Safety according to the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0 for toxicity of grade 3 or higher Adverse Events, Adverse Events of Special Interest, and Serious Adverse Event reporting
2. The magnitude of change from baseline to 1 year in HRQoL in terms of physical functioning from the EORTC QLQ-C30, and sexual activity, pain and physical fatigue from the IL249 item list
3. Time spent on MAB treatment
4. Time to next systemic prostate cancer therapy
5. Health utility derived from patient reported QLQ-C30 data and patient demographics
6. The magnitude of change in HRQoL in terms of physical functioning from EORTC QLQ-C30, and sexual activity, pain characteristics and physical fatigue from the IL249 item list, from baseline to three years
7. Change in HRQoL in terms of the pain and emotional functioning and cognitive functioning scales of EORTC QLQ-C30, and hormonal treatment-related symptoms scale of EORTC IL249 among patients treated with iMAB compared to those on continuous treatment from baseline to one year and three years
8. Change in HRQoL in terms the remaining scales the EORTC QLQ-C30 and IL249 among patients treated with iMAB compared to those on continuous treatment from baseline to one year and three years
9. Evolution of HRQoL in terms of all the scales from EORTC QLQ-C30 and EORTC IL249 among patients in the iMAB and cMAB arms respectively
10. OS and prostate cancer specific survival from start of MAB treatment
11. Proportion of patients with recovered testosterone levels (testosterone > 150 ng/dL) at 1 and 3 years after interrupting their MAB therapy
12. Proportion of patients with PSA ≤ 0.2 ng/mL at 3 years after interrupting their MAB therapy
13. Testosterone and PSA value profiles during the first 3 years
14. Prostate cancer specific survival
15. Enrolment rates via screening log and patient accrual.

Investigational products

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

Test 9

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

European Organisation For Research And Treatment Of Cancer

Sponsor organisation

European Organisation For Research And Treatment Of Cancer

Address

Emmanuel Mounierlaan 83 Bus 11

City

Sint-Lambrechts-Woluwe

Postcode

1200

Country

Belgium

Scientific contact point

Organisation

European Organisation For Research And Treatment Of Cancer

Contact name

Stephanie Kromar

Public contact point

Organisation

European Organisation For Research And Treatment Of Cancer

Contact name

Vassilis Golfinopoulos

Third parties 3

Locations

9 EU/EEA countries · 95 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 47 files

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

Application history

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