STAR Trial- open for enrollment

A multicenter clinical study of the SonablateR 450 for the treatment of locally recurrent prostate cancer with HIFU (High Intensity Focused Ultrasound)

Inclusion Criteria:

  • Organ confined recurrent prostate cancer been treated with radiotherapy 2 or more years ago
  • Negative bone scan within 6 months prior to enrollment, to rule out metastases
  • Negative CT scans of chest, abdomen and pelvis within 6 months , to rule out metastases
  • Age between 40 and 85 years
  • Prostate biopsy within 6 months prior to treatment
  • Prostate volume < 40 gms
  • AP diameter of prostate < 4.0 cm
  • Serum PSA >0.5 ng/ml and <10ng/ml
  • > 90 days post hormone therapy (GnRH agonist/antagonist)

 

GTx Trial-open for enrollment

A phase II, open label study of the effect of GTx – 758 as secondary hormonal therapy on serum PSA and serum free testosterone levels in men with castration resistant prostate cancer maintained on androgen deprivation therapy.

Inclusion Criteria:

  • Age > 18 years
  • Biopsy proven prostate cancer
  • High risk, non-metastatic, castration resistant prostate cancer or have metastatic castration resistant prostate cancer.
  • Treated with androgen deprivation therapy (ADT)-(chemical or surgical) for at least 6 months
  • Castrate level serum total testosterone (< 50 ng/dl)
  • Have a history of serum PSA response on ADT
  • Be continued on ADT throughout this study

 

STRIVE Trial- enrollment closed

A multicenter phase 2, randomized, double-blind, efficacy and safety study of Enzalutamide vs. Bicalutamide in Men with Prostate cancer who has failed primary androgen deprivation therapy.

Inclusion Criteria:

  • Age > 18 years.
  • Histologically or cytologically confirmed adenocarcinoma of the prostate cancer
  • Ongoing androgen deprivation therapy for prostate cancer with a GnRH analogue
  • Serum testosterone level < 50 ng/dl at the screening visit
  • Progressive disease at the study entry
  • Asymptomatic or mildly symptomatic from prostate cancer

 

Dendreon Proceed-Enrollment closed

A registry of Sipuleucel-T therapy in men with advanced prostate cancer

Inclusion Criteria:

  • Age >18 years
  • Advanced prostate cancer who scheduled to receive sipuleucel-T or who underwent their first leukopharesis for manufacture of Sipuleucel-T < 6 months prior to enrollment

 

Dendreon Prime-Enrollment closed

Immune monitoring protocol in men with prostate cancer enrolled in a clinical trial of Sipuleucel-T

Inclusion Criteria:

  • All men with prostate cancer aged > 18 years who are enrolled in a Dendreon-sponsored trial or registry or an investigator –initiated trial and will receive sipuleucel-T are eligible to participate in this trial if they have not yet undergone leukapheresis for their first dose of sipuleucel-T.