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Ensayo controlado aleatorizado2015Financiación no declarada

Effect of Sulforaphane in Men with Biochemical Recurrence after Radical Prostatectomy

Cipolla BG, Mandron E, Lefort JM, Coadou Y, Della Negra E, Corbel L, Le Scodan R, Azzouzi AR, Mottet N

Cancer prevention research (Philadelphia, Pa.) · 96 citas

Etiquetas de revisión

Financiación no declarada

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Cómo se estudió

Diseño
Ensayo controlado aleatorizado (indexado por PubMed)
Estudiado en
Personas
Resultado principal
Marcadores de salud y funcionamiento
Consumo medido con
No se indica

Quién lo pagó

Financiación
Financiación no declarada

Publicación

Publicado
2015-05-12 · Cancer Prev Res (Phila) · vol. 8 · número 8 · págs. 712–719
Editorial
American Association for Cancer Research
Citado
131 citas · más que el 97% de estudios similares · 5.8× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
54 trabajos
Acceso
De pago
Áreas de investigación
Genomics, phytochemicals, and oxidative stress · Estrogen and related hormone effects · Reproductive System and Pregnancy
Palabras clave
Sulforaphane, Placebo, Urology, Medicine, Prostate cancer, Prostatectomy, Clinical endpoint, Randomized controlled trial, Placebo-controlled study, Internal medicine, Cancer, Pathology, Double blind
MeSH
humans, prostatic neoplasms, neoplasm recurrence, local, postoperative complications, isothiocyanates, sulfoxides, prostate-specific antigen, anticarcinogenic agents, neoplasm staging, prognosis, prostatectomy, follow-up studies, pilot projects, double-blind method, aged, male, neoplasm grading

9 autores

  • Bernard G. Cipolla
  • E. Mandron
  • Jean Marc Lefort
  • Yves Coadou🇫🇷Hôpital Saint-Michel
  • Emmanuel Della Negra🇫🇷Centre Hospitalier de Saint-Brieuc
  • Luc Corbel🇫🇷Centre Hospitalier de Saint-Brieuc
  • Ronan Le Scodan🇫🇷Centre Hospitalier privé Saint Grégoire
  • Abdel Rahmène Azzouzi🇫🇷Centre Hospitalier Universitaire d'Angers
  • Nicolas Mottet🇫🇷Hôpital Nord

Resumen

El texto original del estudio, en el idioma en que se publicó.

Increases in serum levels of prostate-specific antigen (PSA) occur commonly in prostate cancer after radical prostatectomy and are designated "biochemical recurrence." Because the phytochemical sulforaphane has been studied extensively as an anticancer agent, we performed a double-blinded, randomized, placebo-controlled multicenter trial with sulforaphane in 78 patients (mean age, 69 ± 6 years) with increasing PSA levels after radical prostatectomy. Treatment comprised daily oral administration of 60 mg of a stabilized free sulforaphane for 6 months (M0-M6) followed by 2 months without treatment (M6-M8). The study was designed to detect a 0.012 log (ng/mL)/month decrease in the log PSA slope in the sulforaphane group from M0 to M6. The primary endpoint was not reached. For secondary endpoints, median log PSA slopes were consistently lower in sulforaphane-treated men. Mean changes in PSA levels between M6 and M0 were significantly lower in the sulforaphane group (+0.099 ± 0.341 ng/mL) than in placebo (+0.620 ± 1.417 ng/mL; P = 0.0433). PSA doubling time was 86% longer in the sulforaphane than in the placebo group (28.9 and 15.5 months, respectively). PSA increases >20% at M6 were significantly greater in the placebo group (71.8%) than in the sulforaphane group (44.4%); P = 0.0163. Compliance and tolerance were very good. Sulforaphane effects were prominent after 3 months of intervention (M3-M6). After treatment, PSA slopes from M6 to M8 remained the same in the 2 arms. Daily administration of free sulforaphane shows promise in managing biochemical recurrences in prostate cancer after radical prostatectomy.

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.

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