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

Primary Purpose

Prostate Cancer

Status

Recruiting

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

68Ga-PSMA (HBED-CC) PET

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring prostate-specific membrane antigen, Lymph Node Dissection, Prostatectomy, Positron-Emission Tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

UZLeuvenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-PSMA PET/MR

Arm Description

Hybrid 68Ga-PSMA PET/MR scan

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Correlation between tracer uptake and pathology Gleason score

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

Assessment of the sensitivity, specificity, positive and negative predictive value

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

Proportion of patients with treatments different from follow-up after the evaluation of 68Ga-PSMA PET/MRI

Full Information

NCT ID

NCT03327675

First Posted

July 10, 2017

Last Updated

November 18, 2022

Sponsor

Universitaire Ziekenhuizen KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT03327675

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 22, 2017 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

188 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

68Ga-PSMA PET/MR

Arm Type

Experimental

Arm Description

Hybrid 68Ga-PSMA PET/MR scan

Intervention Type

Other

Intervention Name(s)

68Ga-PSMA (HBED-CC) PET

Intervention Description

68Ga-PSMA PET/MR

Primary Outcome Measure Information:

Title

Description

Assessment of the sensitivity, specificity, positive and negative predictive

Time Frame

through study completion, an average of 2 year

Secondary Outcome Measure Information:

Title

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

Description

Correlation between tracer uptake and pathology Gleason score

Time Frame

through study completion, an average of 2 year

Title

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

Description

Assessment of the sensitivity, specificity, positive and negative predictive value

Time Frame

through study completion, an average of 2 year

Title

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

Description

Proportion of patients with treatments different from follow-up after the evaluation of 68Ga-PSMA PET/MRI

Time Frame

through study completion, an average of 2 year

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Karolien Goffin, MD, PhD

Phone

003216343714

karolien.goffin@uzleuven.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karolien Goffin, MD, PhD

Organizational Affiliation

UZ Leuven

Official's Role

Principal Investigator

Facility Information:

Facility Name

UZLeuven

City

Leuven

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karolien Goffin, MD-PhD

Phone

+3216343715

karolien.goffin@uzleuven.be

12. IPD Sharing Statement

Citations:

PubMed Identifier

33025093

Citation

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.

Results Reference

derived

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

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