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Trial record 28 of 163 for:    PSMA

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

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ClinicalTrials.gov Identifier: NCT03327675
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: 68Ga-PSMA (HBED-CC) PET Not Applicable

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: High Precision Imaging of Prostate Specific Membrane Antigen for Personalized Treatment in Prostate Cancer
Actual Study Start Date : September 22, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 68Ga-PSMA PET/MR
Hybrid 68Ga-PSMA PET/MR scan
Other: 68Ga-PSMA (HBED-CC) PET
68Ga-PSMA PET/MR




Primary Outcome Measures :
  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. [ Time Frame: through study completion, an average of 2 year ]
    Assessment of the sensitivity, specificity, positive and negative predictive


Secondary Outcome Measures :
  1. The correlation of tracer uptake to Gleason scores within the prostate tumor and within metastatic lymph nodes. Work unit 1. [ Time Frame: through study completion, an average of 2 year ]
    Correlation between tracer uptake and pathology Gleason score

  2. Comparison of diagnostic accuracy between 68Ga-PSMA PET, MR and combined 68Ga-PSMA PET/MR. Work unit 2. [ Time Frame: through study completion, an average of 2 year ]
    Assessment of the sensitivity, specificity, positive and negative predictive value

  3. The evaluation of change in patient management based on imaging results of 68Ga-PSMA PET/MR in patients with biochemical recurrence. Work unit 2. [ Time Frame: through study completion, an average of 2 year ]
    Proportion of patients with treatments different from follow-up after the evaluation of 68Ga-PSMA PET/MRI



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03327675


Contacts
Contact: Karolien Goffin, MD, PhD 003216343714 karolien.goffin@uzleuven.be

Locations
Belgium
UZLeuven Recruiting
Leuven, Belgium
Contact: Karolien Goffin, MD-PhD    +3216343715    karolien.goffin@uzleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Karolien Goffin, MD, PhD UZ Leuven

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03327675     History of Changes
Other Study ID Numbers: S59428
2016-003089-14 ( EudraCT Number )
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universitaire Ziekenhuizen Leuven:
prostate-specific membrane antigen
Lymph Node Dissection
Prostatectomy
Positron-Emission Tomography

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases