High Precision Imaging of Prostate Specific Membrane Antigen for Personalized Treatment in Prostate Cancer

NCT ID: NCT03327675

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-22
• Study Completion Date: 2025-12-31

Brief Summary

This is an Investigator Initiated, non-commercial, single center, non-randomized, single arm, open label pilot study on 194 patients. The patients are affected by prostate cancer but in two different clinical settings. The first group is characterized by patients who are going to be operated of radical prostatectomy and they will undergo the study imaging preoperatively. The second group experiences biochemical relapse after primary treatment.

Detailed Description

Novel, sensitive tools, such as 68Ga-PSMA PET imaging, have great potential for very early disease detection and open the possibility of early curative local salvage treatment (with surgery, radiotherapy or a combination of both). This project will moreover provide important insights into the biodistribution and dosimetry of 68Ga-PSMA, opening possibilities of 90-Yttrium or 177-Lutetium-PSMA-based radionuclidetherapy of patients with metastatic PC in the future.

The study consists of 2 work units (WU):

Work-unit 1: Patients at high risk for nodal involvement prior to radical prostatectomy with extended lymph node dissection Work-unit 2: Biochemical recurrence after initial treatment with curative intent

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

68Ga-PSMA PET/MR

Hybrid 68Ga-PSMA PET/MR scan

Group Type: EXPERIMENTAL

68Ga-PSMA (HBED-CC) PET

Intervention Type: OTHER

68Ga-PSMA PET/MR

Interventions

68Ga-PSMA (HBED-CC) PET

68Ga-PSMA PET/MR

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Work-unit 1

• age < 75 years of age, with histologically proven invasive adenocarcinoma of the prostate
• a risk of equal or more than 5% of lymph node metastasis (intermediate to high risk disease), according to the Briganti nomogram (1)
• scheduled to undergo radical prostatectomy with extended lymph node dissection

Work-unit 2

• histologically proven diagnosis of prostate cancer
• biochemical relapse (two consecutive PSA≥0.2 ng/ml) of prostate cancer following radical local prostate treatment
• WHO performance state 0-1
• age > 18 years old

Exclusion Criteria

Work-unit 1

• involvement of pelvic lymph nodes assessed by multi-parametric MRI
• evidence for bone metastasis assessed by bone scan (if PSA > 20 ng/ml)
• WHO performance status > 2
• previous pelvic irradiation or radical prostatectomy.
• other malignancy except adequately treated basal cell carcinoma of the skin diagnosed during the last 5 years
• any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

Work-unit 2

• serum testosterone level <50ng/ml
• symptomatic metastases
• local relapse on MRI
• PSA rise while on active treatment with LHRH-agonist, LHRH-antagonist, Anti-androgen, Complete androgen blockade, Oestrogen-antioestrogen therapy
• previous treatment with cytotoxic agent for PCa
• treatment during the past month with products known to influence PSA levels (e.g. fluconazole, finasteride, corticosteroids,…)
• disorder precluding understanding of trial information or informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karolien Goffin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

UZLeuven

Leuven, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Karolien Goffin, MD, PhD

Role: CONTACT

karolien.goffin@uzleuven.be

003216343714

Facility Contacts

Karolien Goffin, MD-PhD

Role: primary

karolien.goffin@uzleuven.be

+3216343715

References

Draulans C, De Roover R, van der Heide UA, Kerkmeijer L, Smeenk RJ, Pos F, Vogel WV, Nagarajah J, Janssen M, Isebaert S, Maes F, Mai C, Oyen R, Joniau S, Kunze-Busch M, Goffin K, Haustermans K. Optimal 68Ga-PSMA and 18F-PSMA PET window levelling for gross tumour volume delineation in primary prostate cancer. Eur J Nucl Med Mol Imaging. 2021 Apr;48(4):1211-1218. doi: 10.1007/s00259-020-05059-4. Epub 2020 Oct 6.

Reference Type: DERIVED

PMID: 33025093 (View on PubMed)

Other Identifiers

2016-003089-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

S59428

Identifier Type: -

Identifier Source: org_study_id