99mTechnetium based PSMA-Radioguided Assisted surgery for prostate Cancer feasibility Study
- Conditions
- prostate cancer10038597
- Registration Number
- NL-OMON50122
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 25
* Male, aged * 18 years.
* Hormone-sensitive recurrent protstate cancer after radical prostatectomy ,
external beam radiotherapy or brachytherapy
* Less than a number of 4 soft tissue lesions (lymph node; connective tissue)
within the pelvis or retroperitoneum with sufficient PSMA expression (*3 times
regional vascular activity level) as determined by PSMA-based PET
* PSA-value <4ng/mL
* Had a PSMA PET/CT within 60 days before surgery
* Suitable for salvage lymph node dissection, as per institutional guidelines.
* WHO performance status 0,1, or 2.
* Written informed consent.
* Suspicion of local recurrent prostate cancer within the prostatic fossa not
treatable by surgery
* Nonregional lymphadenopathy (cM1a) or distant metastases (cM1b/c) as assessed
by preoperative PSMA PET/CT.
* Ongoing androgen deprivation therapy (ADT) or within 6 months prior to
surgery.
* Severe claustrophobia interfering with PET/CT or SPECT/CT scanning
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* Investigation of the feasibility of 99mTc-PSMA RGS in salvage lymph node<br /><br>dissection in men with recurrent PC after intravenously injection of<br /><br>99mTc-PSMA-I&S.</p><br>
- Secondary Outcome Measures
Name Time Method