Lutetium-177-PSMA in Oligo-metastatic Hormone Sensitive Prostate Cancer.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Stichting Radboud University Medical Center

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

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

Trial duration

27 Jul 2020 → 19 Jan 2026

Decision date (initial)

2024-07-31

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

VriendenLoterij N.V. · Radboud Oncologie Fonds, Nijmegen, The Netherlands · Advanced Accelerator Applications International SA (Novartis)

External identifiers

EU CT number

2023-509881-39-00

EudraCT number

2020-000076-37

ClinicalTrials.gov

NCT04443062

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

The primary aim is to study the effect of 177Lu-PSMA RLT in patients with oligo-metastatic, hormone sensitive metastatic PCa, by comparing the fraction of patients that have disease progression (as a surrogate for progression free survival) and meet EOT 1 criteria within 6 months in a group of patients that are treated with 177Lu-PSMA RLT and a group that follows the current standard of care (deferred androgen deprivation therapy).

Secondary objectives 1

1. Secondary aim will be to estimate the ADT free survival, response, toxicity defined by NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0), radiological state of the disease expressed in the difference in amount and size of suspicious nodes 18F-PSMA PET and (whole body) MRI between pre- and post-therapy and quality of life assessments.

Conditions and MedDRA coding

prostate cancer

Regulatory references

Plan to share IPD

No

IPD plan description

Will be decided upon completion of the trial

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. Histological proven adenocarcinoma of the prostate with sufficient archived tumor material. This material has to be archived till study closure
2. Biochemical recurrence (PSA > 1.0 μg/l)
3. PSA-doubling time < 6 months. Serum PSA progression is defined as 2 consecutive rising PSA values measured at least 1 week apart. The minimal start value is 0.2 μg/l
4. 18F-PSMA-PET-CT positive metastases in bones and/or lymph nodes (N1/M1ab): ≥1, maximally 5 metastases
5. Local treatment for oligo-metastases with radiotherapy or surgery appears to be no option anymore (due to prior treatment or the location of the metastatic lesions or if the patient refuse these treatments)
6. No prior hormonal therapy (including any androgen directed treatment such as finasteride, dutasteride, bicalutamide, apalutamide, abiraterone or enzalutamide) or taxane based chemotherapy (docetaxel or cabazitaxel); testosterone > 1.7 nmol/l. Exception: local prostate cancer treated with local radiotherapy plus adjuvant ADT; these patients need to be stopped with ADT at least 6 months
7. A detectable lesion on the 18F-PSMA PET/CT with significant PSMA avidity, defined by a SUVmax > 15 (partial volume corrected)
8. ECOG 0-1
9. Patients must have a life expectancy >6 months
10. Laboratory values: • White blood cells > 3.0 x 109/l • Platelet count > 75 x 109/l • Hemoglobin > 6.2 mmol/l • ASAT, ALAT < 3 x ULN • MDRD-GFR ≥ 50 ml/min
11. Signed informed consent

Exclusion criteria 8

1. A known subtype other than prostate adenocarcinoma
2. Previous PSMA based radioligand treatment
3. Visceral or brain metastases
4. Any medical condition present that in the opinion of the investigator will affect patients’ clinical status when participating in this trial
5. Prior hip replacement surgery potentially influencing performance of PSMA PET/CT
6. Sjogren's syndrome
7. A second active malignancy other than prostate cancer
8. Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. The main study parameters are the fractions of patients that have disease progression (as a surrogate for progression free survival defined in paragraph 2: objectives) within 6-month follow up in the two arms
2. A second main study parameter is the time to disease progression and meeting EOT 1 criteria in both groups

Secondary endpoints 1

1. Secondary endpoints will be the ADT free survival, PSA response, toxicity defined by NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0), radiological state of the disease expressed in the difference in amount and size of suspicious nodes 18F-PSMA PET/(diagnostic) CT and (whole body) MRI between pre- and post-therapy and quality of life assessments, in both arms

Investigational products

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

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Stichting Radboud University Medical Center

Sponsor organisation

Stichting Radboud University Medical Center

Address

Geert Grooteplein Zuid 10

City

Nijmegen

Postcode

6525 GA

Country

Netherlands

Scientific contact point

Organisation

Stichting Radboud University Medical Center

Contact name

Nuclear Medicine RLT research office

Public contact point

Organisation

Stichting Radboud University Medical Center

Contact name

Nuclear Medicine RLT research office

Locations

2 EU/EEA countries · 4 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 8 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