Trial record 17 of 38 for:    prostate cancer screening | Open Studies

The Role of Androgen Deprivation Treatment (ADT) in Docetaxe-Prednisolone Chemotherapy for Castrate-Resistant Prostatic Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Asan Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
JLee, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01487902
First received: December 5, 2011
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

The purpose of this study is to assess the androgen deprivation therapy when patients with castration-resistant prostate cancer are treated with docetaxel-based chemotherapy.


Condition Intervention Phase
Castration-resistant Prostate Cancer
Drug: ADT
Drug: No ADT
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Screening Trial of Docetaxel Plus Prednisolone With or Without Androgen Deprivation Treatment in Castrate-Resistant Prostatic Cancer

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Time to PSA progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Composite progression-free survival (PFS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    PFS based on PSA, RECIST, bone scan, and performance status

  • Overall survival [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  • PSA decline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • PSA response to ADT retrial [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    ADT will be rechallenged to patients assigned to no ADT arm when their disease progress despite of docetaxel-prednisolone chemotherapy.

    The PSA response to ADT rechallenge, such as PSA response based on PCWG v1.0, will be assessed and the number of patients with PSA response and the amount of PSA decline will be reported.



Estimated Enrollment: 90
Study Start Date: July 2010
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADT arm
Concomitant androgen deprivation treatment
Drug: ADT
Luprolide 11.25 mg long-acting depo (Lucrin Depot PDS inj®) every 12 weeks SC wit Docetaxel-prednisolone (TAX327 regimen)
Active Comparator: No ADT arm
No concomitant androgen deprivation treatment arm
Drug: No ADT
Docetaxel-prednisolone (TAX327 regimen) alone

Detailed Description:

Androgen deprivation therapy (ADT) has been the mainstay in the treatment of metastatic prostate carcinoma. Despite initial favorable responses, predictable and irreversible resistance to ADT will occur in the vast majority of patients, which is defined as Castrate-Resistant prostate cancer (CRPC).

Recently, TAX327 study revealed docetaxel plus prednisolone could not only improve the QOL and PSA response but also prolong the survival in CRPC. It has been reasoned that discontinuation of ADT in nonorchiectomized patients may have detrimental effect on patients with CRPC as discontinuation of ADT can result in renewed release of testosterone and possible stimulation of remaining androgen-sensitive elements. When exogenous testosterone therapy is administered to patients with symptomatic CRPC, adverse responses can be induced. However, the lowest concentration of endogenous androgens that is capable of stimulating tumor growth is unknown. Data from animal models of androgen-dependent tumors showed that androgen-independent status is usually followed by androgen-insensitivity, which support the no need for ADT in CRPC. Contradictory, Dunning rat prostate cancer model cell lines, which are androgen-insensitive in vitro and grow slowly in the castrate rat, can grow more rapidly in a host with intact testis. In the retrospective observational study of CRPC treated with anthracycline, platinum, or ketoconazole, Taylor, et al. showed a modest, but statistically significant, survival advantage when ADT is continued. But, Hussain et al. and our team reported that there was no obvious advantage of continued ADT in response to cytotoxic chemotherapy or survival for in patients with CRPC. In addition, prospective trial conducted by Shamash, et al. showed that hormonal sensitivity can be reintroduced by stopping ADT during chemotherapy for CRPC. Among 43 patients who restarted androgen blockade after the completion of chemotherapy without ADT, 37% of patients had PSA response which was associated with survival advantage. Despite the limited and retrospective information available on the impact of continued ADT on disease outcome in CRPC when treated with cytotoxic chemotherapy, especially docetaxel containing regimen, ADT is frequently advocated to be used continuously. Considering little information on the benefit of continued ADT, and cost and side effects of ADT, prospective comparative studies are eagerly needed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Clinical or radiologic evidence of metastatic disease
  • Documented disease progression during hormone therapy (ADT with or without antiandrogen)
  • Cessation of ADT at least 4 weeks in non-orchiectomized patients
  • Adequate duration (at least 4 weeks for flutamide and 6 weeks for bicalutamide) of anti-androgen withdrawal (only for patients who showed a response or decline in PSA for more than 3 months)
  • KPS ≥ 60
  • No prior cyto-toxic chemotherapy (except estramustine) or radioisotopes
  • No prior radiotherapy 25% or more of the bone marrow
  • No peripheral neuropathy grade 2 or worse
  • Adequate organ and bone marrow function

Exclusion Criteria:

  • Other tumor type than adenocarcinoma
  • Presence or history of CNS metastasis
  • Other serious illness or medical conditions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01487902

Contacts
Contact: Jae-Lyun Lee, MD, PhD 82 2 3010 5977 jaelyun@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Hee Jeong Jeon, BSc         
Contact: Jae-Lyun Lee, MD, PhD.         
Sub-Investigator: Hanjong Ahn, MD, PhD.         
Sub-Investigator: Jun-Hyuk Hong, MD, PhD.         
Sub-Investigator: Cheryn Song, MD, PhD.         
Sub-Investigator: In-Gab Jeong, MD, PhD         
Sponsors and Collaborators
Asan Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: JLee, Associate professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01487902     History of Changes
Other Study ID Numbers: UOSG-AMC-0803
Study First Received: December 5, 2011
Last Updated: December 7, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
Chemotherapy-naive

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Genital Diseases, Male
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Androgens
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents

ClinicalTrials.gov processed this record on September 18, 2014