TheraP : A Randomised Phase 2 Trial of 177Lu-PSMA617 Theranostic Versus Cabazitaxel in Progressive Metastatic Castration Resistant Prostate Cancer

Male<br/>OnlyGender Male
Only

RecruitingStatus Recruiting

Multiple<Br/>Treatment TypesTypeMultiple
Treatment Types

TwoPhase Two

18+Age Over 18

Prostate<br/>CancersCancer LocationProstate
Cancers

Multiple treatment types | Urinary systemProstate

Trial Overview Read MoreRead more

This phase II trial is comparing a type of radionuclide therapy with a type of chemotherapy for the treatment of metastatic castration resistant prostate cancer that has advanced on other therapies.
 

This trial is treating patients with castration resistant prostate cancer.

This is a systemic therapy and radiotherapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Randomised Phase 2 Trial of 177Lu-PSMA617 Theranostic Versus Cabazitaxel in Progressive Metastatic Castration Resistant Prostate Cancer

Cooperative Group

Australian & New Zealand Urogenital and Prostate Cancer Trials Group Limited (ANZUP)

Other Non-Commercial Sponsor

Prostate Cancer Foundation of Australia

Summary

The aim of this study is to determine the activity and safety of LuPSMA radionuclide therapy. Patients with metastatic prostate cancer who have progressed despite hormonal therapy and chemotherapy, will be randomised to receive either LuPSMA radionuclide therapy (up to a maximum of 6 cycles of therapy) or cabazitaxel chemotherapy (up to a maximum of 10 cycles of therapy). 200 participants will be recruited from sites across Australia. The study will determine the effects on PSA response rate (primary endpoint), pain response, progression free survival, quality of life, and frequency and severity of adverse events. Correlative outcomes include associations between PET imaging and clinical outcomes, and biomarkers and clinical outcomes.

Recruiting Hospitals Read MoreRead more

Olivia Newton-John Cancer Wellness & Research Centre
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Monash Health, Medical Oncology
Clayton
Genitourinary Research Study Coordinator
gu.oncresearch@monashhealth.org

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Ms Marian Lieschke
marian.lieschke@petermac.org
03 8559 7140

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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