Prostate Neoplasm Clinical Trial
Official title:
Pilot Study: Lutetium-177-PSMA-617 in Low Volume Metastatic Prostate Cancer
Radioligand therapy (RLT) using Lu-177 labelled PSMA is a promising new therapeutic approach to treat metastatic prostate cancer. This tumor-specific treatment is directed against prostate-specific membrane antigen (PSMA), which is overexpressed in prostate cancer cells. In the last few years, several lutetium-177 (177Lu, β emitter) labeled PSMA ligands have been developed and are currently applied to treat metastatic castrate resistant prostate cancer (mCRPC) patients. However, there are no prospective studies published so far using this treatment approach in hormone sensitive setting. In this pilot study patients with hormone sensitive prostate cancer who did not undergo hormonal treatment will be treated with Lu-177 PSMA-617.
Radioligand therapy (RLT) is a promising new therapeutic approach to treat metastatic
prostate cancer. This tumor-specific treatment is directed against prostate-specific membrane
antigen (PSMA), which is overexpressed in prostate cancer cells. In the last few years,
several lutetium-177 (177Lu, β emitter) labeled PSMA ligands have been developed and are
currently applied in nuclear medicine departments world-wide to treat metastatic castrate
resistant prostate cancer (mCRPC) patients.
A large retrospective study reported an overall biochemical response rate of 45% following
multiple 177Lu-PSMA RLT cycles in mCRPC patients, while 40% of patients already responded
after a single cycle. RLT with PSMA ligand PSMA-617 was generally well tolerated and 12% of
the patients suffered grade 3 to 4 hematological toxicity. In addition, mild and often
transient xerostomia occurred in 8%. These results were confirmed in a smaller scale
prospective study published recently.
Although these results are very promising, it is noteworthy that all currently
Lu-177-PSMA-617 RLT only has been evaluated in end stage prostate cancer patients to date. In
theory, RLT could be more effective in low volume disease because of the very high tumor
uptake of radioligands in small lesions. There are no published data so far evaluating the
therapeutic effect of Lu-177-PSMA-617 RLT in an earlier stage of the disease. Because of the
difference in tumor load between mCRPC patients and patients with low volume metastatic
disease, dosimetry and toxicity in these patients need evaluation. Here a clinical trial to
investigate the efficacy of Lu-177-PSMA-617 RLT in patients with low volume metastatic
prostate cancer, prior to the hormone insensitive state is proposed.
Objective: The aim of this study is to evaluate the dosimetry and toxicity of Lu-177-PSMA-617
RLT, in patients with low volume, hormone sensitive metastatic prostate cancer under
treatment condition. Ultimately, the goal of this study is to stabilize previously
progressive disease in these patients and to improve the quality of life by postponing the
need for androgen deprivation therapy (ADT).
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