177Lu-PSMA as a systemic adjuvant treatment in patients with high and very high risk prostate cancer after radical treatment with locoregional teleradiotherapy and hormone therapy.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

9 Jan 2025 → ongoing

Decision date (initial)

2023-09-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Agencja Badań Medycznych (project ABM nr 2021/ABM/03/00031)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

Assessment of treatment failure - the assesment of biochemical progression ratio, defined (according to the Phoenix criteria) as a rise of PSA by 2 ng/mL or more above the nadir (defined as the lowest PSA achieved after treatment), proven by a consecutive examination performed at least 4 weeks later.

Secondary objectives 5

1. Biochemical Progression Free Survival (bPFS) asessment, defined (accoring to the Phoenix criteria) as a rise of PSA by 2 ng/mL or more above the nadir (defined as the lowest PSA achieved after treatment), proven by a consecutive examination performed at least 4 weeks later.
2. Radiological Progression Free Survival (rPFS), defined in accordance to the PCWG3 criteria.
3. Assessment of the time to inclusion of the next therapeutic intervention.
4. Safety and Tolerabilty assessment according to the Common Terminology Criteria for Adverse Events (CTCAE v. 5.0).
5. Quality of life assessment.

Conditions and MedDRA coding

Prostate Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Histopathologically proven high-risk or very-high-risk prostate cancer (according to NCCN v1.2023): 1) high-risk patients: clinical advancement stage cT3a, or 4 or 5 ISUP grading group (with no leading Gleason 5 component), or PSA >20 ng/mL; lack of very-high-risk signs 2) very-high-risk patients: Clinical advancement stage cT3b-cT4, or ISUP 5 grading main group (with leading Gleason 5 component), or 2 or 3 features of high-risk, or >4 cores with 4 or 5 risk group in biopsy samples
2. Completion of radical locoregional treatment – teleradioteraphy.
3. Completion of locoregional treatment within 3 months before inclusion to the study.
4. Giving a written informed consent.
5. ECOG performance status 0 to 2.
6. Age over 18 years.
7. No signs of tumour cells dissemination within 28 days before inclusion to the trial, proven by radiological examinations (CT/or in case of contraindications to CT – MR of chest, abdomen and pelvis) and 68Ga-PSMA PET/CT examination.
8. Castrate testosterone level (testosterone < 50 ng/dl or 1,7 nmol/L)
9. Patients with adequate function of main organs, defined as an adequate reserve of bone marrow and function of liver and kidneys: 1. bone marrow - neutrophils > 1500x109/L; thrombocytes > 100 000x109/L; hemoglobin > 9 g/dL; 2) liver - bilirubin < 2xUNL (upper limit of normal range) and < 5xULN in patients with Gilbert's syndrome; aminotransferase < 3xUNL; 3) kidneys - eGFR > 50 ml/min; albumins > 2.5mg/ml
10. In men with procreative ability: consent to the implementation of double barrier contraception method.

Exclusion criteria 5

1. The presence of distant metastases, proven by radiological examination or PET/CT examination with 68Ga-PSMA.
2. Absence of approval to use effective constraception method.
3. Absence of Patient's consent to participate in the study.
4. Urinary tract obstruction or/and hydronephrosis.
5. Concurrent anticancer treatment.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The assessment of biochemical failure ratio.

Secondary endpoints 5

1. Biochemical Progression Free Survival - time of survival from the end of 177Lu-PSMA treatment to biochemical progression or death.
2. Radiological Progression Free Survival - time of survival from the end of 177Lu-PSMA treatment to the radiological progression defined accoring to the PCWG3 criteria or death.
3. Time from the end of 177Lu-PSMA treatment to inclusion of other therapeutic intervention.
4. Frequency and count of Patients with adverse events.
5. The comparison of quality of life ratios (EORTC QLQ-PR25) between study groups.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy

Sponsor organisation

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy

Address

Ul. Wybrzeze Armii Krajowej 15

City

Gliwice

Postcode

44-102

Country

Poland

Scientific contact point

Organisation

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy

Contact name

Centrum Wsparcia Badań Klinicznych

Public contact point

Organisation

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy

Contact name

Centrum Wsparcia Badań Klinicznych

Locations

1 EU/EEA country · 1 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 6 files

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

Application history

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