Clinical Trials
Now Underway
Ferring FE200486
CS021
An Open-label, Multicenter, Randomized, Parallel-group Study,
Investigating the Efficacy and Safety of Degarelix One Month Dosing
Regimens; 160mg(40mg/ml) and 80mg (20mg/ml), in Comparison to LUPRON
DEPOT 7.5mg in Patients with Prostate Cancer Requiring Androgen Ablation
Therapy
This study is intended for patients with prostate cancer (with or
without metastases) who have not undergone hormonal treatment. If
qualified, the patient will receive either LUPRON DEPOT 7.5mg, or
Degarelix every 28 days for 12 months. Patients may have had a
prostatectomy or radiotherapy or be candidates for either. The
medication is supplied gratis to enrolling patients. Both agents are
effective in the main objective of therapy which is the lowering of
testosterone levels.
Non-Metastatic disease:
GlaxoSmithKline AVO105948
A Randomized, Double-Blind, Placebo-Controlled Trial Assessing the
Efficacy and Safety of Dutasteride in Extending the Time to Progression
of Low-risk, Localized Prostate Cancer in Men who are Candidates for or
Undergoing Expectant Management
Patients eligible for this study will have low risk of progression and
are choosing to follow a “watchful waiting” management of their disease.
Patients will either receive dutasteride or placebo to be taken once
daily for 3 years and will have biopsies at 18 months and 3 years. This
study will assess if dutasteride may decrease disease progression and
eliminate the need for, or extend the time period to implementation of
more aggressive therapy as compared to placebo. The careful physician,
study coordinator, PSA and biopsy follow-up serve to document any change
in disease activity.
Sanofi-Aventis
A Multicenter, Open-Label, Randomized, Phase III Trial Comparing
Immediate Adjuvant Hormonal Therapy (ELIGARD) in Combination with
TAXOTERE (docetaxel) Administered Every Three Weeks versus Hormonal
Therapy Alone versus Deferred Therapy Followed by the Same Therapeutic
Options in Patients with Prostate Cancer at High Risk of Relapse After
Radical Prostatectomy
Patients in this study must have had a radical prostatectomy within 90
days of enrollment and no plans for radiation treatment. This study is
intended for patients with a high risk for recurrence. Patients will
receive either hormone therapy (ELIGARD) for 18 months alone, or in
combination with the chemotherapy agent TAXOTERE, administered every 3
weeks. Some will start these treatments immediately, others may be
randomized to a deferred arm where the treatment will start once there
is a rise in PSA or other signs of clinical progression.
SWOG 9921
Adjuvant Androgen Deprivation versus Mitoxantrone
Plus Prednisone Plus Androgen Deprivation in Selected High Risk Prostate
Cancer Patients Following Radical Prostatectomy, Phase III
Patients in this study must have had a radical prostatectomy within 120
days of enrollment. This study is intended for patients with a high risk
for recurrence. Patients will receive either hormone therapy (ZOLADEX +
CASODEX) alone for 2 years, or in combination with the chemotherapy
agents mitoxantrone and prednisone, administered every 3 weeks.
Radiation is permitted in this study.
Metastatic disease:
CALGB 90202
A Randomized Double-Blind, Placebo-Controlled Phase III Study of
Early vs. Standard Zoledronic Acid to Prevent Skeletal Related Events in
Men with Prostate Cancer Metastatic to the Bone
Patients must have at least one bone lesion seen by X-ray. They must be
on Hormone Therapy less than 3 months. They may have had Hormone Therapy
in the past, if it was less than 6 months of treatment, ending at least
1 year ago. No previous bone-building medications like Fosamax or Boniva
may have been taken. Zoledronic acid (ZOMETA) may promote bone health.
Dendreon 9902b
A Randomized, Double-Blind, Placebo Controlled Phase III Trial of
Immunotherapy with Autologous Antigen Presenting Cells Loaded with PA224
(Provenge) in Men With Metastatic, Androgen Independent Prostatic
Adenocarcinomas
This study is intended for patients who no longer respond to hormone
therapy and whose cancer has spread to the bone or soft tissue. Patients
will have a portion of their blood cells harvested and sent to a
processing lab. There, either PROVENGE or a placebo will be added to the
cells and then returned to the site. The patient will have their own
“treated” cells returned to their body through an infusion. This
procedure will occur 3 times, 2 weeks apart. The patient will be
monitored throughout the study with periodic bone and CT scans.
Dendreon PB01
An Open Label, Single Arm Trial of Immunotherapy with Autologous
Antigen Presenting Cells Loaded with PA2024 (PROVENGE) for Subjects with
Objective Disease Progression and Disease-Related Pain on Trial D9902b
Patients who received placebo on Dendreon 9902b and who have had disease
progression are the only patients eligible for this crossover trial.
SWOG ID00-156
A Randomized
Phase III Trial Comparing Consolidation Therapy With or Without
Strontium-89 Following Induction Chemotherapy in Androgen-Independent
Prostate Cancer
Patients must have a rising PSA, greater than 5 ng/ml, plus bone pain or
a worsening bone scan in less than 6 months time. Failure of combined
hormone therapy must be demonstrated by stopping Casodex for 6 weeks,
and having a PSA still showing progression. Bone lesions must be shown
on Bone Scan or CT. Patient may have had one prior series of
chemotherapy at least 4 weeks earlier. They may not be on medications
that limit acid production in the stomach (Maalox, Zantac, Prilosec,
Pepcid, Tums, etc.). Those patients with other active cancer, a heart
attack or mini-stroke within one year, are not eligible. Ongoing
illness, including liver and bone marrow problems, may be a
disqualifier. Strontium 89 may add to the successful treatment effect of
chemotherapy on the bone.
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