99mTechnetium based PSMA-Radioguided Assisted surgery for prostate Cancer feasibility Study

99mTechnetium based PSMA-Radioguided Assisted surgery for prostate Cancer feasibility Study - TRACE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50122

Enrollment

Registered

2020-03-04

Start date

2020-05-11

Completion date

Unknown

Last updated

2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
• 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

Measure	Time frame
• 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	—

Measure

Time frame

• 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

—

Countries

Netherlands

Outcome results