High precision imaging for personalized prostate cancer treatment

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

This study is testing a special imaging technique to see if it can help doctors better treat prostate cancer in patients preparing for surgery or those whose cancer has returned after treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 188 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Universitaire Ziekenhuizen KU Leuven (other)
• Locations: 1 site (Leuven)
• Trial ID: NCT03327675 on ClinicalTrials.gov

What this trial studies

This pilot study investigates the use of 68Ga-PSMA PET imaging in patients with prostate cancer, focusing on two groups: those scheduled for radical prostatectomy and those experiencing biochemical relapse after initial treatment. The study aims to enhance early disease detection and inform potential curative local salvage treatments. By analyzing the biodistribution and dosimetry of 68Ga-PSMA, the research seeks to pave the way for future radionuclide therapies for metastatic prostate cancer. The study is non-randomized and involves a single center with a total of 194 participants.

Who should consider this trial

Good fit: Ideal candidates include men under 75 with high-risk prostate cancer scheduled for surgery or those with biochemical relapse after initial treatment.

Not a fit: Patients with pelvic lymph node involvement or bone metastasis, as well as those with poor performance status, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and personalized treatment options for prostate cancer patients.

How similar studies have performed: Other studies utilizing PSMA PET imaging have shown promising results, indicating potential for success in this novel approach.

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

Where this trial is running

Leuven

• UZLeuven — Leuven, Belgium (RECRUITING)

Study contacts

• Principal investigator: Karolien Goffin, MD, PhD — UZ Leuven
• Study coordinator: Karolien Goffin, MD, PhD

Conditions: Prostate Cancer, prostate-specific membrane antigen, Lymph Node Dissection, Prostatectomy, Positron-Emission Tomography