Timing of Post-prostatectomy PSMA Imaging

Prostate Cancer Clinical Trial

— TOPP  

Official title:

A Phase II Randomized Feasibility Study Comparing Early Salvage Radiotherapy Versus Surveillance With Delayed Repeat PSMA PET/CT Imaging in Patients Presenting With Early Biochemical Relapse of Prostate Cancer Following Radical Prostatectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05008900
• Other study ID #: 21-5040
• Status: Recruiting
• Phase: Phase 2
• Start date: March 22, 2022
• Est. completion date: September 2031

Study information

• Verified date: May 2023
• Source: University Health Network, Toronto
• Contact: Srinivas Raman, MD
• Phone: 416-946-2320
• Email: srinivas.raman[@]rmp.uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators will randomize patients presenting with early BCR with a negative baseline PSMA PET/CT, to upfront SRT or surveillance. Early BCR is defined as a PSA relapse of >0.1 to <0.3 ng/mL. Patients in the surveillance arm will be monitored with PSA every 3 months. A repeat PSMA PET/CT will be undertaken when the PSA reaches a target level of >0.5 to <1.0 ng/mL. Both early radiation treatment and surveillance with repeat PSMA PET/CT imaging are within patterns of practice locally; therefore, the investigators believe that there is clinical equipoise on this subject.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2031
• Est. primary completion date: September 2030
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically-proven prostate cancer
• pT1-T4 pN0/Nx cM0
• PSA at BCR >0.1 - <0.3 ng/mL post-radical prostatectomy
• PSMA PET/CT negative at BCR post radical prostatectomy
• Planned SRT to prostate bed +/- pelvic lymph nodes
• ECOG 0 or 1
• Age = 18 years
• Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.

Exclusion Criteria:

• Active or post prostatectomy androgen deprivation use
• Previous pelvic radiotherapy
• Other contraindications to radiotherapy

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatectomy
• Prostatic Neoplasms

Intervention

Radiation:
• Salvage radiotherapy
Standard of care salvage radiotherapy to the prostate bed which may include the lymph nodes.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Center	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surveillance with delayed PSMA PET scan	This study will assess the feasibility of surveillance with delayed repeat PSMA PET/CT in patients with BCR of prostate cancer following radical prostatectomy with negative baseline PSMA PET/CT. A treating physician questionnaire will be completed prior to screening and enrollment, as well as PSA results every three months for surveillance patients.	7 years