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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001530213
Acronym
IMPPORT
Enrollment
100
Registered
2018-09-13
Start date
2018-06-01
Completion date
2020-06-01
Last updated
2021-03-08

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

Conditions

None listed

Brief summary

The purpose of this study is to see whether the use of a particular type of PET scan will improve detection rates of cancer, and improve treatment management. Who is it for? You may be eligible for this study if you are aged over 18 and have been referred for radiotherapy after a prostatectomy. Study details All participants in this study will be required to undergo a PET/CT scan and a diagnostic CT Chest/Abdomen Pelvis You will also be asked to fill out a quality of life Questionnaire. before and after commencing radiotherapy. You will be reviewed as part of your routine care with a routine blood test which will monitor your PSA levels at these visits you will be asked to complete a quality of life Questionnaire. It is hoped this research will determine if the use of PET scanning in treatment planning and how it influences radiation treatment planning in patients will improve treatment outcomes for patients with prostate cancer.

Interventions

18FDCPyL is an investigational radioactive diagnostic imaging agent indicated for positron emissiontomography (PET) in patients with cancer where knowledge of the distribution of Prostate SpecificMembrane Antigen (PSMA) throughout the body. To assess the role and impact of a new imaging scan, 18FDCPyLPET in patients referred for salvage radiotherapy (radiation treatment when prostate cancer has recurred) following radical prostatectomy forprostate cancer. 18FDCPyLPET/CT has previously shown to p

18FDCPyL is an investigational radioactive diagnostic imaging agent indicated for positron emissiontomography (PET) in patients with cancer where knowledge of the distribution of Prostate SpecificMembrane Antigen (PSMA) throughout the body. To assess the role and impact of a new imaging scan, 18FDCPyLPET in patients referred for salvage radiotherapy (radiation treatment when prostate cancer has recurred) following radical prostatectomy forprostate cancer. 18FDCPyLPET/CT has previously shown to provide high resolution imagery in targeted areas Participants will have an 18FDCPyLPET/CT scan, in which the results will determine what management pathway best suits them. Participants will be required to have 1 PET/CT scan this scan will take approximately 2 hours. The PET imaging will be performed in the imaging department by qualified Nuclear Medicine Specialists 250 MBq +/50 MBq, depending on patient weight and activity provided on day of scan

Sponsors

GenesisCare Cancer Care Research
Lead SponsorOther Collaborative groups

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 23, 2026