The potential use of 99mTechnetium (99mTc)-based PSMA-radioguided surgery (99mTc-PSMA-RGS) for salvage lymphadenectomy for PC.
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Investigation of the feasibility of 99mTc-PSMA RGS in salvage lymph node
dissection in men with recurrent PC after intravenously injection of
99mTc-PSMA-I&S.
Secondary outcome
• To evaluate if 99mTc-PSMA-RGS aids intra-operative localization of nodes that
had previously been detected as positive on pre-operative PSMA PET/CT to ensure
PC lymph nodes are not missed at operative salvage lymph node dissection.
• To establish optimal imaging protocol for pre-operative 99mTC-PSMA-I&S
SPECT/CT and interval between imaging and surgery.
• Determine the diagnostic accuracy of 99mTc-PSMA-I&S RGS compared to
histologic evaluation after either 15-19 hours compared to 20-24 hours after
intravenously injection of 99mTc-PSMA-I&S.
• Complete biochemical response (PSA <0.2ng/mL) 30 days, 3, 6, 12 and 24 months
after salvage surgery without adjuvant prostate cancer specific (hormonal or
radiation) treatment.
• Diagnostic accuracy of 99mTc-PSMA-I&S radioguided salvage surgery compared to
histologic evaluation
• Diagnostic accuracy of preoperative Ga-PSMA-PET or 18F-DCFPyl-PSMA-PET and
99mTc-PSMA-SPECT/CT compared to histologic evaluation.
• To assess the number of in field recurrences (recurrence measured by use of
PSMA PET/CT in the template of 99mTc-PSMA-RGS supported salvage lymph node
dissection) in men with biochemical recurrence.
• Assessment of 99mTc-PSMA-I&S injection-related as well as surgery-related 30-
and 90-day complication rate according to Clavien-Dindo.
Background summary
Prostate cancer (PC) is the most common cancer in men. The ability to
accurately determine the location and extent of lymph node involvement in PC
has significant implications on decision-making regarding treatment modality
and ongoing management planning. The European Association of Urology PC
guidelines recommend, for staging in clinically localized intermediate and
high-risk cancer, a pelvic lymph node dissection (PLND). Despite this, 25-35%
of the PC patients who are treated with curative intent with radical
prostatectomy (RP) and extended PLND will develop clinically significant
biochemical recurrence with local and/or distant disease. Even with an extended
template dissection including external iliac, hypogastric and obturator nodes,
35% of lymph nodes potentially containing PC will not be removed at surgery,
either being out of the standard surgical field, or being missed within.
Improvements in pre-operative and intra-operative techniques for detection of
lymph node metastases may result in a shift towards increased cure and lower
biochemical recurrence rates in patients with primary diagnosed PC and/or in
patients with recurrent PC with lymph node metastasis in pelvis and
retroperitoneum.
Study objective
The potential use of 99mTechnetium (99mTc)-based PSMA-radioguided surgery
(99mTc-PSMA-RGS) for salvage lymphadenectomy for PC.
Study design
An investigator initiated, prospective, non-randomized, pilot feasibility
study.
Study burden and risks
Other than either one or two preoperative 99mTc-PSMA scintigraphic imaging
procedures including SPECT/CT scans (with a single intravenous injection of
99mTc-PSMA-I&S), this study will not result in any procedures different from
the standard procedures
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
• 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.
Exclusion criteria
• 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCTnummervolgt |
| CCMO | NL68290.031.18 |