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US 2003/0147936 A1Published application
Prostatic hormonal implants treatment of prostate cancer
OwnerVelayudhan Sahadevaninventor
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OwnerVelayudhan Sahadevaninventor
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An improved method and products for the primary hormonal treatment of early stage, low and intermediate risk prostate cancers by prostatic implants of androgen suppressive drugs formulated as fused with a lipoid carrier or encapsulated in microcapsules or in Silastic capsules is provided. Such prostatic implants renders a constant slow-release of their contents to the prostate for extended periods by biodegradation and diffusion. It facilitates higher prostatic and lower systemic concentrations of androgen suppressive hormones. Because of their high prostatic and lower systemic concentrations, tumor control is much improved and the their systemic toxicity is minimized. Tumor control after such primary hormonal implant treatment is followed by clinical examinations and the biochemical tumor control is followed by periodic estimations of serum levels of PSA and acid phosphatase. More complex and expensive surgery or radiation therapy for this group of good prognostic early stage prostate cancer is reserved for those patients failing to this primary hormonal treatment. It will preserve potency more than by surgery or radiation therapy. Furthermore, it would reduce the cost of treatment for early stage prostate cancer significantly. Androgen suppressive hormonal implants to the prostate before, during or after lower dose conventional radiation therapy would also facilitate equal or better cure rates of localized prostate cancer as compared to the more complex and toxic higher dose radiation therapy.
An improved method of primary hormonal treatment with lesser or no toxic effect as primary treatment of early stage, low and intermediate risk prostate cancer and said primary hormonal treatment comprising of prostatic implants of steroid hormones, or its synthetic derivatives in one or more slow release formulations and permitting said drugs to be continuously released at near constant rate directly to prostate for longer periods and maintaining said formulation's serum level sufficient to effect suppression of androgen synthesis but low enough to minimize or to eliminate systemic toxicity.
An improved method of concomitant hormonal and radiation treatment of prostate cancer and said hormonal treatment comprising of prostatic implants of steroid hormones in one or more slow release formulations and permitting said drugs to be continuously released at near constant rate directly to the prostate during the radiation therapy and afterwards for longer periods and maintaining said formulation's serum level sufficient to effect suppression of androgen synthesis but low enough to minimize or to eliminate their toxicity.
A prostatic, subcutaneous or intramuscular implant method for hormonal treatment of prostate cancer for improved tumor control and less toxicity from hormonal treatment than by administering said hormonal compositions by oral, or intravenous routes and said hormonal treatment comprising of prostatic, subcutaneous or intramuscular implants of steroid hormones and or their synthetic derivatives in one or more slow release formulations.
Slow-release anti-cancer prostate implants products for primary treatment of early stage T0-T2b prostate cancer before surgery or radiation therapy and comprising of a natural or synthetic estrogens and antiandrogens as fused with a lipoid carrier or as encapsulated in Silastic capsules or as injectable microcapsules and are suitable for prostatic implantation such that said hormonally and cytotoxically effective compositions are continuously released at relatively high constant rates to the prostate and their lower concentrations reaching the systemic circulation that is effective to suppress the testicular and adrenal androgen synthesis by inhibition of LHRH, FSH and LH secretions but with lesser toxicity.
A prostatic, subcutaneous or intramuscular slow-release hormonal implant method and products comprising single or synergetic combination of hormonally and cytotoxically effective compositions selected from the natural or synthetic derivatives from the groups consisting of estrogens, progesterones, corticosteroids, from the anti-androgen groups consisting of flutamide, bicalutamide and nilutamide and they are fused with a lipoid carrier or encapsulated in Silastic capsules or formulated as injectable microcapsules as suitable slow-release prostatic, subcutaneous or intramuscular implantation and implanting said products for the treatment of early and advanced stage prostate cancers or as hormonal treatment combined with radiation.
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