Evaluation of PSMA-PET and mpMRI in high-risk prostate cancer – using histopathologic validation

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Vasterbotten, Umea University

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05], Diseases [C] - Neoplasms [C04], Diseases [C] - Male Urogenital Diseases [C12]

Trial duration

14 Oct 2024 → ongoing

Decision date (initial)

2024-03-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

To evaluate and compare the accuracy of PSMA-PET and mpMRI for identification and delineation of the most clinically relevant intra-prostatic lesions or sub-regions.

Secondary objectives 6

1. The secondary objective is to study the prognostic potential of PSMA-PET and mpMRI using histopathology as reference standard.
2. The secondary objective is to study the potential for risk-classification of lesions or subparts of lesions including extracapsular extension and seminal vesicle involvement
3. The exploratory objective is to study the potential for image processing steps that improve the correlation between histopathology, molecular characteristics, and imaging.
4. The exploratory objective is to investigate the potential use of machine learning to predict tumour lesions properties from mpMRI and PSMA-PET
5. The exploratory objective is to investigate the possibility to define these types of lesions in future radiotherapy patients, where they can be subject to a radiotherapy boost, meaning increased dose towards that volume to maximize the probability for curing the patient.
6. The safety objective is to assess any subject-reported adverse events.

Conditions and MedDRA coding

Prostate cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Histologically confirmed high-risk prostate cancer planned to be treated with radical prostatectomy
2. PSMA-PET/CT conducted as part of the clinical management for the existing prostate cancer
3. ≥4 weeks since last biopsy of the prostate
4. One or more of the following criteria: a) cT3, or high suspicion of extra prostatic growth on mpMRI b) Gleason score ≥8 c) PSA 20-49 ng/ml
5. >18 years
6. Given a written consent to participate in the trial

Exclusion criteria 10

1. Non-MR-safe implants or another contraindication to MRI or PET
2. Claustrophobia
3. Unfit for MRI or PET/MRI examination for any other reason, e.g., back pain
4. WHO PS >1
5. Patients treated with neoadjuvant/concomitant anti-testosterone treatment (surgical or medical castration such or anti-androgens)
6. TUR-P within 6 months
7. Metastatic disease in skeleton, parenchymal organs, or lymph nodes outside the pelvis.
8. Patients with previous diagnosis of other malignant disease. Exceptions could be made for basal cell carcinoma of the skin or progression free survival at least 10 years after any previous tumor.
9. Creatinine clearance < 30ml/min
10. Tinnitus or severe hearing loss

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is spatially defined aggressive PC lesions, or subparts of lesions, identified and defined using PSMA-PET and/or mpMRI compared to histopathology

Secondary endpoints 4

1. The secondary endpoints are biochemical disease-free survival, time to relapse, overall survivor and surgical margins.
2. The secondary endpoint is to the assess the radiological extracapsular extension and seminal vesicle involvement in comparison to histopathological evaluation.
3. The exploratory endpoint of the study is also the spatially defined most aggressive PC lesions, or subparts of lesions.
4. The safety endpoint is subject-reported adverse events up to one week after treatment.

Investigational products

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

Test 1

Auxiliary 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Vasterbotten

Sponsor organisation

Region Vasterbotten

Address

Koksvagen 11, Alidhem Alidhem

City

Umea

Postcode

907 37

Country

Sweden

Scientific contact point

Organisation

Region Vasterbotten

Contact name

Tufve Nyholm

Public contact point

Organisation

Region Vasterbotten

Contact name

Tufve Nyholm

Umea University

Sponsor organisation

Umea University

Address

Universitetstorget 4, Alidhem Alidhem

City

Umea

Postcode

907 36

Country

Sweden

Scientific contact point

Organisation

Umea University

Contact name

Tufve Nyholm

Public contact point

Organisation

Umea University

Contact name

Tufve Nyholm

Sponsor responsibilities

Article 77 compliance

Region Vasterbotten

Contact point sponsor

Region Vasterbotten

Article 77 implementation

Region Vasterbotten

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

Application history

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