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.