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Timing of Post-prostatectomy PSMA Imaging (TOPP)

Primary Purpose

Prostate Cancer, Prostatectomy

Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Salvage radiotherapy
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Princess Margaret Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Surveillance

Salvage radiotherapy

Arm Description

Patients with early biochemical relapse of prostate cancer following radical prostatectomy who have a PSA greater than or equal to 0.1 to less than 0.3 ng/mL with negative PSMA PET/CT will go on surveillance. Routine PSA will be conducted and a repeat PSMA PET/CT imaging will be conducted when the PSA rises to greater than 0.5 to less than 1.0 ng/mL.

Patients with early biochemical relapse of prostate cancer following radical prostatectomy who have a PSA of greater than or equal to 0.1 to less than 0.3 ng/mL with negative PSMA PET/CT will receive salvage radiotherapy to the prostate bed. This radiotherapy may or may not include the pelvic lymph nodes.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 12, 2021
Last Updated
May 7, 2023
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT05008900
Brief Title
Timing of Post-prostatectomy PSMA Imaging
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2022 (Actual)
Primary Completion Date
September 2030 (Anticipated)
Study Completion Date
September 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostatectomy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Feasibility
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surveillance
Arm Type
Experimental
Arm Description
Patients with early biochemical relapse of prostate cancer following radical prostatectomy who have a PSA greater than or equal to 0.1 to less than 0.3 ng/mL with negative PSMA PET/CT will go on surveillance. Routine PSA will be conducted and a repeat PSMA PET/CT imaging will be conducted when the PSA rises to greater than 0.5 to less than 1.0 ng/mL.
Arm Title
Salvage radiotherapy
Arm Type
No Intervention
Arm Description
Patients with early biochemical relapse of prostate cancer following radical prostatectomy who have a PSA of greater than or equal to 0.1 to less than 0.3 ng/mL with negative PSMA PET/CT will receive salvage radiotherapy to the prostate bed. This radiotherapy may or may not include the pelvic lymph nodes.
Intervention Type
Radiation
Intervention Name(s)
Salvage radiotherapy
Intervention Description
Standard of care salvage radiotherapy to the prostate bed which may include the lymph nodes.
Primary Outcome Measure Information:
Title
Surveillance with delayed PSMA PET scan
Description
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.
Time Frame
7 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Srinivas Raman, MD
Phone
416-946-2320
Email
srinivas.raman@rmp.uhn.ca
Facility Information:
Facility Name
Princess Margaret Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Srinivas Raman, MD
Phone
416-946-2320
Email
srinivas.raman@rmp.uhn.ca

12. IPD Sharing Statement

Learn more about this trial

Timing of Post-prostatectomy PSMA Imaging

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