[177Lu]Lu-PSMAI&T radioligand therapy (PSMA-RLT) for patients with prostate cancer and biochemical but not radio-morphological local recurrence after primary therapy with curative intent: A Prospective Phase II Pilot Study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Vienna

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

9 Dec 2024 → ongoing

Decision date (initial)

2024-12-09

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-519348-34-00

EudraCT number

2022-003713-11

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

Evaluate the prostate specific antigen (PSA) response to [177Lu]Lu-PSMAI&T-RLT.

Assess therapy toxicity of systemic [177Lu]Lu-PSMAI&T-RLT.

Conditions and MedDRA coding

prostate carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Patients must be adults ≥ 18 years of age. • Patients with BCR primarily treated with RP and patients with BCR primarily treated with RT with a PSA doubling-time (PSADT) of ≤ 12months. • No hormonal therapy within the last 12 months and/or recovered testosterone levels. • [68Ga]Ga-PSMA-11 PET negative result for local recurrence; presence of distant metastases is allowed: (cN0, cM0/cM1). • Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1 • Patients must have adequate bone marrow reserve: WBC ≥1.5 x 109 /L, Platelets ≥100 x 109 /L and Haemoglobin ≥9 g/dL. • Patients must have adequate renal function with eGFR ≥ 50mL/min/1.73m2 using the Modification of Diet Renal Disease (MDRD) equation and an Albumin level of ≥2.5 g/dL. • Patients must be able to sign Informed Consent Form.

Exclusion criteria 1

1. Concomitant participation in any other interventional trial. • Concurrent severe oncologic and medical conditions that result in patients not having a life expectancy of longer than one year. • Presence of clinically relevant somatic or psychiatric diseases that might interfere with the objectives and assessments of the study. • Complete urinary out-flow obstruction or severe unmanageable urinary incontinence.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. PSA response in term of PSA decline of ≥ 50% from baseline value. • Emerge therapy toxicity in terms of pathological reduction of values of blood count, kidney and liver functions from baseline levels assessed by CTCAE (v5.0).

Investigational products

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

Test 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Vienna

Sponsor organisation

Medical University Of Vienna

Address

Spitalgasse 23, Alsergrund Alsergrund

City

Vienna

Postcode

1090

Country

Austria

Scientific contact point

Organisation

Medical University Of Vienna

Contact name

Department of Biomedical Imaging and Image-guided Therapy, Division of Nuclear Medicine

Public contact point

Organisation

Medical University Of Vienna

Contact name

Department of Biomedical Imaging and Image-guided Therapy, Division of Nuclear Medicine

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 7 files

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

Application history

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