Clinical trial NCT03327675: 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
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate-specific membrane antigen
Lymph Node Dissection
Prostatectomy
Positron-Emission Tomography
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 188
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: 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.
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: The correlation of tracer uptake to Gleason scores within the prostate tumor and within metastatic lymph nodes. Work unit 1.
timeFrame: through study completion, an average of 2 year
measure: Comparison of diagnostic accuracy between 68Ga-PSMA PET, MR and combined 68Ga-PSMA PET/MR. Work unit 2.
timeFrame: through study completion, an average of 2 year
measure: The evaluation of change in patient management based on imaging results of 68Ga-PSMA PET/MR in patients with biochemical recurrence. Work unit 2.
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
Study officials:
affiliation: UZ Leuven
name: Karolien Goffin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.