This patent describes use of Accutane/isotretinoin/13-cis-retinoic acid to shrink the prostate gland and drastically reduce PSA levels in patients with benign prostate hyperplasia; effects sought after with 5-alpha reductase inhibitor treatments like finasteride and dutasteride.
Some noteworthy out-takes:
In one embodiment, the present invention provides methods of treatment of benign prostatic hyperplasia and reduction of the level of the prostate specific antigen (PSA) of benign prostate conditions.
The instant invention derived from the observation that the human prostate comprises a modified sebaceous gland and that, given the many years of usage of successful Accutane®/isotretinoic/retinoic acid in the treatment of acne, this through the shrinking of sebaceous glands within the face and neck, that a similar action might occur upon the prostate gland if Accutane® were taken as an oral medication
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Operating with the informed consent of approximately twelve patients exhibiting either or both an elevated PSA, that is, patients with a PSA of greater than 4 ng/ml and/or with exhibiting benign prostatic hyperplasia, the patients were treated with Accutane® manufactured by Roche
^ “Approximately” twelve patients were treated??? Or did they only receive informed consent of 11 and 1/2 of the patients? 
Examples 1 to 4 illustrate clinical effectiveness of the above described treatment method. It was found that none of the conditions of these patients worsened either in terms of PSA or hyperplasia, and none progressed into any form of diagnosable malignancy. Further, no serious adverse side effects or contra-indications of any kind were observed among the patients in the informal trials.
EXAMPLE 1
A patient started a slowly progressive prostatic enlargement and attenuated urine stream 20 years ago. Hand examination confirmed a palpably enlarged prostate, probably secondary to post vasectomy prostatitis.
The patient was placed on 40 mg of 13-cis retinoic acid (in the form of Accutane®) orally for 14 days in the initial treatment. Then he was placed on sustaining dose of 40 mg of 13-cis retinoic acid (in the form of Accutane®) every 5 days for about one year.
The patient’s symptoms improved steadily. His prostate decreased in palpable size, and PSA dropped from 4 to less than one.
No adverse side effects were noted other than drying of lips and some musculo-skeletal soreness at sites of old injuries to the fingers and neck. This soreness subsided slowly after the sustaining dose was instituted. Blood chemistries remained normal on this low sustaining dosage.
EXAMPLE 2
The patient had prior histories of urethritis and prostatitis from sexually transmitted diseases. The patient had steadily increasing prostatic enlargement, with decreasing urine flow, plus urgency and nocturia. PSA was 3, and prostate palpably enlarged.
The patient was placed on 40 mg of 13-cis retinoic acid (in the form of Accutane®) orally for 14 days. Then the dosage was decreased to 40 mg of 13-cis retinoic acid (in the form of Accutane®) every 5 days for about one year.
The patient had steady improvement in symptoms and after 6 months PSA had dropped to less than one. No adverse side effects were observed from administration of the Accutane®.
EXAMPLE 3
A patient had history of post-traumatic prostatitis caused by a bicycle accident in 1987. The patient’s condition became chronic especially after long auto trips, and required frequent courses of antibiotics and steroids to calm the inflammation. PSA was 5.
The patient was placed on 40 mg of 13-cis retinoic acid (in the form of Accutane®) daily for 14 days. Thereafter, the patient had a maintenance dosage of 40 mg of 13-cis retinoic acid (in the form of Accutane®) every 5 days for about one year.
The patient rapidly became symptom free after the initial treatment, and had remained so during the sustaining period. PSA dropped to less than 1.
EXAMPLE 4
The patient had a history of sexually transmitted diseases in college and subsequent history of prostatitis. Enlargement of prostate was noted 6 years prior to the Accutane treatment, with steadily worsening urinary tenesmus.
The patient was placed on 40 mg of 13-cis retinoic acid (in the form of Accutane®) per day. After 14 days, the dosage was decreased to 40 mg of 13-cis retinoic acid (in the form of Accutane®) every 5 days for about one year.
The patient’s symptoms readily improved and PSA dropped from 4 to less than 1 within 6 months.
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Thanks to @kyahll for bringing this to attention.