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Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

2624 - ReCab II: A phase II trial of Cabazitaxel +/- Rhenium -188-HEDP in patients with metastatic castration resistant prostate cancer who progressed on or after a docetaxel containing treatment

Date

22 Oct 2018

Session

Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

Topics

Cytotoxic Therapy

Tumour Site

Prostate Cancer

Presenters

Esther Bouman-Wammes

Citation

Annals of Oncology (2018) 29 (suppl_8): viii271-viii302. 10.1093/annonc/mdy284

Authors

E. Bouman-Wammes1, J.M. van Dodewaard-De Jong2, H. Bloemendal3, H.M. Verheul1, J.M.H. de Klerk4, A.J.M. van den Eertwegh1

Author affiliations

  • 1 Medical Oncology, Vrije University Medical Centre (VUMC), 1081 HV - Amsterdam/NL
  • 2 Medical Oncology, Meander Medical Center, 3818KX - Amersfoort/NL
  • 3 Medical Oncology, Meander Medical Center, 3813 TZ - Amersfoort/NL
  • 4 Nuclear Mediciine, Meander Medical Center, 3818KX - AMERSFOORT/NL
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Resources

Abstract 2624

Background

Bone is the most common site of metastases in patients with castration resistant prostate cancer (CRPC) leading to serious morbidity and mortality. Nowadays, cabazitaxel is the standard second line of chemotherapy. Besides, a survival benefit has been proven for the alfa-emitting radiopharmaceutical Radium-223-chloride and has been suggested for other, beta-emitting, radiopharmaceuticals such as rhenium-188-HEDP as well. Rhenium-188-HEDP has a proven and favorable effect on pain caused by bone metastases. In this trial, we will investigate the effect of the addition of rhenium-188-HEDP to standard treatment with cabazitaxel on the progression free survival, overall survival and quality of life.

Trial design

In total, 86 patients with CRPC metastatic to bone and progressive disease during or after treatment with docetaxel will be included. Patients will be randomized between two arms. Patients in arm A will be treated with the standard schedule of cabazitaxel; cabazitaxel 25mg/m2 every three weeks. Patients in the intervention arm will receive an injection of rhenium-188-HEDP 40 MBq/kg three weeks after the second and three weeks after the fourth administration of cabazitaxel 25mg/m2. The interval between the injection of the rhenium-188-HEDP and the next cycle of cabazitaxel will be 4 weeks because of nadir of the expected thrombopenia after 4 weeks. The primary endpoint is progression free survival, with overall survival, clinical benefit, quality of life, PSA and pain response and toxicity as secondary endpoints. PSA, pain and quality of life will be measured every treatment cycle (i.e. every 3 weeks), imaging will be performed pre-cycle 4 and pre-cycle 7, or when progression is suspected based on clinical findings or a rise in PSA. The statistical analysis will be performed by using a stratified logrank test comparing both groups with respect to the time to progression. Time-to-event will be analyzed by the Kaplan-Meier method.

Clinical trial identification

Legal entity responsible for the study

AJM Van den Eertwegh.

Funding

Sanofi Genzyme Teva Pharma.

Editorial Acknowledgement

Disclosure

All authors have declared no conflicts of interest.

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