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

NCT03327675 | Recruiting

• 2 other identifiers: S594282016-003089-14
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate-specific membrane antigen; Lymph Node Dissection; Prostatectomy; Positron-Emission Tomography

Outcome Measures

Primary Outcomes (1)

• 68Ga-PSMA PET/MR imaging accuracy before radical prostatectomy + pelvic lymph node dissection [RP + PLND]. Work unit 1. 68Ga-PSMA PET/MR imaging accuracy in patients with biochemical recurrence after primary treatment. Work unit 2.

  Assessment of the sensitivity, specificity, positive and negative predictive

  through study completion, an average of 2 year

Secondary Outcomes (3)

• The correlation of tracer uptake to Gleason scores within the prostate tumor and within metastatic lymph nodes. Work unit 1.

  through study completion, an average of 2 year

• Comparison of diagnostic accuracy between 68Ga-PSMA PET, MR and combined 68Ga-PSMA PET/MR. Work unit 2.

  through study completion, an average of 2 year

• The evaluation of change in patient management based on imaging results of 68Ga-PSMA PET/MR in patients with biochemical recurrence. Work unit 2.

  through study completion, an average of 2 year

Study Arms (1)

68Ga-PSMA PET/MR

EXPERIMENTAL

Hybrid 68Ga-PSMA PET/MR scan

Other: 68Ga-PSMA (HBED-CC) PET

Interventions

68Ga-PSMA (HBED-CC) PET OTHER

68Ga-PSMA PET/MR

68Ga-PSMA PET/MR

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZLeuven

Leuven, Belgium

RECRUITING

Related Publications (1)

• 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.

  PMID: 33025093 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11; N,N'-bis(2-hydroxy-5-(ethylene-beta-carboxy)benzyl)ethylenediamine N,N'-diacetic acid; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Karolien Goffin, MD, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karolien Goffin, MD, PhD

CONTACT

003216343714; karolien.goffin@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: October 31, 2017
• Study Start: September 22, 2017
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

BE (1)