PredicTive value of FluoR-18 PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT before PLND for lymph nodE staging in primary pRostate cancer
- Conditions
- cancer of the prostateprostate cancer1003836410038365
- Registration Number
- NL-OMON55108
- Lead Sponsor
- Catharina-ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 70
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1. Biopsy proven adenocarcinoma of the prostate;
2. Indication for (super)extended PLND (with or without (robot-assisted)
laparoscopic prostatectomy), in intermediate and high risk patients ( d*Ámico
score) with an MSKCC >5% lymph node prediction;
3. Mentally competent and understanding of benefits and potential burden of the
study;
4. Written informed consent;
5. Age >=18 years.
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1. History of prior diagnosed or treated PCa.
2. Known concomitant malignancies (except Basal Cell Carcinoma of the skin).
3. Unwillingness or inability to undergo 18F-PSMA-1007 PET/CT and anti-3-[18F]
FACBC PET/CT, in combination with PLND.
4. Metastasis beyond pelvic region and/or bone metastasis. Patients with bone
metastasis will not get a PLND, but will be included in the study for further
follow-up.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameter is patient- and lesion-based diagnostic accuracy of<br /><br>18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT in detection of lymph node<br /><br>metastases. Secondary study parameters are (a) diagnostic performance of<br /><br>18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT in detection of distant<br /><br>metastases, (b) diagnostic performance of 18F-PSMA-1007 PET/CT and anti-3-[18F]<br /><br>FACBC PET/CT in staging of the primary tumor in the prostate specimen, (c)<br /><br>detection rate of 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT as a<br /><br>function of PSA level, nomogram risk and size of suspected lymph nodes, (d)<br /><br>change of management induced by 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC<br /><br>PET/CT and (e) cost-associated with 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC<br /><br>PET/CT as diagnostic modality additional to the regular diagnostic work-up<br /><br>versus pelvic lymph node dissection.</p><br>
- Secondary Outcome Measures
Name Time Method