Sperm Count, Low Clinical Trial
Official title:
Impact of Immunotherapy in the Spermogram
Cancer is a public health problem. In recent years, oncology has been revolutionized with the
advent of new treatments for different tumor models, mainly immunotherapy directed against
cell cycle control points. Numerous inhibitory pathways are incorporated into the immune
system to maintain tolerance and homeostasis, and these are collectively known as
immunological checkpoints.
The main function of immunological checkpoints is to protect tissues from damage when the
immune system is responding to pathogens and maintain tolerance to self antigens (ie, prevent
autoimmunity). This is mainly achieved by down-regulation of T cell activation or effector
functions. There is increasing evidence to show that a primary mechanism by which tumors
evade the immune system is through the participation of immunological checkpoints. This has
stimulated the development of many novel agents that modulate immunological checkpoints or
other costimulatory receptors.
CTLA-4 is the first receptor of the checkpoint that is successfully selected as
immunotherapy. Ipilimumab, an anti-CTLA-4 monoclonal antibody, was the first immunological
checkpoint inhibitor to receive FDA approval for the treatment of advanced melanoma.
On the other hand, PD-1 is another receptor for the immune control point, and its ligands,
the programmed cell death ligand 1 (PD-L1) and PD-L2, also resulted in important therapeutic
advances in cancer immunotherapy.
Unlike CTLA-4, PD-1 is widely expressed and can be found in, in addition to T cells, in B
cells and natural killer (NK) cells. The main function of PD-1 is to limit the activity of T
cells in peripheral tissues during an inflammatory immune response.
The tumors can exploit this control point, expressing the ligand PD-L1 and generating that
the cytotoxic T lymphocytes and the NK cells are anergic and incapable of killing. This
up-regulation mechanism of PD-L1 is known in tumors such as melanoma, lung and ovary. Several
monoclonal antibodies directed to PD-1 have already received approvals for their clinical use
as Nivolumab and Pembrolizumab.
The toxic effect of cytostatics (chemotherapy) at the gonadal level is known, but the effect
that anti PD-1 immunotherapy can have on the spermogram of oncological patients at the level
of the blood-testicular barrier, endocrine axis, among others, is not known. The
proinflammatory mechanisms of immunotherapy could incur in damage evidenced as
quali-quantitative alterations of the spermogram.
Primary end point:
To evaluate the difference in spermogram (counting, functionality, vitality, mobility) before
and after treatment with anti-PD1 immunotherapy first line of oncological treatment of adult
patients
Secondary end point:
Evaluate the association adjusted for nutrition, endocrine disorders. Evaluate modifications
in the sexual functionality of patients through validated sexuality questionnaires before and
during treatment.
In the absence of information, according to the results obtained, cryopreservation prior to
the start of treatment could be taken into consideration.
Design: Observational prospective cohort with a single group. With start of follow-up from
the oncological diagnosis of patients who are in the process of starting treatment with
immunotherapy, checkpoint inhibitors in first line setting. The spermogram samples will be
performed: 2 baseline before the start of the drug and +/- 5 days of the start of the
treatment, separated by at least 2 weeks. Subsequent samples will be taken 3, 6 and 12 months
after the start of treatment.
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