Prostate Cancer Clinical Trial
Official title:
The Effect of Androgen Deprivation Therapy on Prostate Specific Membrane Antigen (PSMA) in Prostate Cancer
Phase A: To describe and to determine the maximum standardised uptake values (SUV) in
prostate specific membrane antigen positron emission tomography (PSMA-PET) before ADT and 7,
14 and 28 days after ADT.
Phase B: To validate phase A results by comparing the PSMA-PET findings to histopathological
analysis of regional lymph nodes acquired from radical prostatectomy specimens. PSMA-PET is
done before ADT and at maximum SUV defined by the phase A.
Positron emission tomography has been commonly and successfully used, in combination with CT
and MRI devices, in the staging of intermediate or high risk prostate cancer. Proper staging
is essential to guide the treatment options, which usually are radical prostatectomy or
radiotherapy in localized prostate cancer or hormonal treatment in patients with metastasized
disease, patients with hormonal relapse after radical radiotherapy or as an adjuvant
treatment together with radiotherapy.
The use of PET imaging increases the sensitivity in the evaluation of lymph node involvement,
as almost 80% of metastatic lymph nodes in prostate cancer are smaller than the threshold
size usually measured with CT or MRI.
Nowadays new specific receptor targeted PET tracers in prostate cancer imaging has been
introduced. One of the most used is 68Ga-PSMA that evaluates the expression of
prostate-specific membrane antigen. This tracer has been rapidly taken into account for its
better sensitivity and specificity in prostate cancer staging compared to the lipid
metabolism tracers, like 11C/18F labeled fluorocholine or 11C-acetate.
In the recent literature it has been demonstrated for the first time on humans that PSMA
expression, imaged with 68Ga-PSMA-11-PET, has increased in a patient with metastatic prostate
cancer after androgen deprivation therapy (ADT).
These findings suggest that the use of hormonal therapy can affect the expression of PSMA and
our hypothesis is that ADT therapy could increase the sensitivity of 68Ga-PSMA PET to detect
nodal or distant metastasis in patients with prostate cancer. This prospective study consists
in two phases. In phase A, 5 patients with newly diagnosed high risk prostate cancer with
PSMA-positive nodal or distant metastasis screened by 68Ga-PSMA-11 PET/MRI, are given
androgen deprivation therapy (ADT) with GNRH antagonist. After ADT therapy initiation,
68Ga-PSMA-11 PET/MRI is repeated at 7, 14 and 30 days to determine the highest PSMA
expression based on SUVmax measurement.
In phase B, 20 high risk prostate cancer patients determined to undergo radical prostatectomy
are screened with 68Ga-PSMA-11 PET/MRI, and then given GNRH antagonist therapy. 68Ga-PSMA-11
PET/MRI is repeated at the time of maximum PSMA expression based on phase A results. The
patients then undergo radical prostatectomy and lymphadenectomy and imaging findings are
matched with histological data.
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