IMPPORT Trial: Impact of 18F-DCFPyL PET scanning in patients undergoing post-prostatectomy Radiotherapy

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer; Cancer - Prostate

• Registration Number: ACTRN12618001530213
• Lead Sponsor: GenesisCare Cancer Care Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-13
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

Men being referred and suitable for radiotherapy to the prostate-bed and/or pelvis.
Biochemical recurrence defined as PSA greater than 0.2 ng/mL and less than2.0 ng/mL
Prior radical prostatectomy with or without pelvic lymph node dissection
Staging immediately prior to prostatectomy showed no evidence of metastatic disease: TanyNanyM0. Any prior imaging permitted including CT, bone scan and previous functional imaging scans.
Pathological staging following prostatectomy: pTany, pNany
Histopathology of Acinar adenocarcinoma or ductal carcinoma
Age over 18 years
PSA within 4 weeks of PET/CT

Exclusion Criteria

Established distant metastases
No prior pelvic or prostate bed radiotherapy
Prostate cancer with significant sarcomatoid or neuroendocrine small cell components
Significant intercurrent morbidity that, in the judgement of the investigator, would limit compliance with the study protocols
Current androgen deprivation therapy or anti-androgen therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The impact of PET/CT will be based on change in treatment intent compared to 1) intent prior to any imaging performed and 2) intent based on the diagnostic CT result<br>Grading will be similar to the system reported by van Leeuwen et al: (28) - 1) None, 2) Moderate and 3) Major, with an addition of classification of ‘Ignored’<br>[36 Months post enrolment]

Secondary Outcome Measures

Name	Time	Method
To compare the detection of disease using 18F-DCFPyL PET/CT compared to diagnostic computer tomography specially in pelvic nodal (N) or metastatic disease (M)<br>Kaplin Meier time to event actuarial curves will be constructed to examine disease progression or nodal/distant failure[36 months post enrolment]