Clinical trial NCT01087580: Docetaxel + Prednisone With or Without Radiation for Castrate Resistant Prostate Cancer
Official title: A Randomized Phase-II Pilot Trial of Docetaxel and Prednisone Versus Radiation Therapy Plus Docetaxel and Prednisone in Patients With Nonmetastatic and Oligometastatic Castrate Resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: PROSTATE CANCER
Keywords: Prostate Cancer
non metastatic prostate cancer
oligometastatic prostate cancer
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2010-03-16
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to find out whether adding radiation therapy to the standard treatment of chemotherapy for prostate cancer is tolerated well and is more effective than the standard treatment of chemotherapy alone

Detailed description: Most physicians would consider chemotherapy to be the standard for prostate cancer. In this study all participants will receive the standard chemotherapy. In addition, half the participants will also receive radiation therapy. It is hoped that the radiation therapy will provide additional benefit. The use of radiation therapy and chemotherapy for patients with this kind of cancer is not considered standard treatment at the present time.

Participants will be randomized into groups (or Arms) by a computer program. Participants randomized to Arm 1 will receive chemotherapy alone. Participants in Arm 2 will receive chemotherapy and radiation therapy. Participants in both groups (Arm 1 and Arm 2) will receive standard chemotherapy with docetaxel and prednisone. Docetaxel is given through a needle in a vein in the arm every 3 weeks or 21 days. Participants will take a prednisone tablet once per day until 21 days after the last dose of docetaxel. In addition, all participants will be given a drug called dexamethasone twice daily for 6 doses to help with the side effects of docetaxel. Participants in Arm 2 will first receive radiation therapy to the pelvis and prostate gland. Radiation therapy will be delivered once a day, five days a week for a total of 8-9 weeks. Then beginning 4-6 weeks after the end of radiation therapy, chemotherapy will be given, as described above. In both Arms, the total number of cycles of docetaxel and prednisone will depend upon how the tumor responds to these drugs. All patients should receive a minimum of three cycles of chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Participants must have a diagnosis of castrate resistant prostate cancer.
* Participants must be 18 years old or older.
* Biopsy of tissue from the prostate or enlarged lymph nodes may be required.
* Patients must sign study specific informed consent prior to study entry.
* Men of child-producing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months afterwards.

Exclusion Criteria:

* Participants cannot have prior chemotherapy for prostate cancer.
* Participants cannot have prior radiation therapy to the pelvis.

Primary outcomes:
measure: Estimation of progression free survival(PFS) and response rate
timeFrame: Day one of each treatment cycle. cycles are every 21 days and at the end of post-treatment
Secondary outcomes:
measure: Overall survival of patients
timeFrame: at study completion and during follow-up (At least every 3 months (12 weeks) until evidence of progression or relapse for a maximum of 2 years, subsequently every 4 months for 2 years, then every 6 months for 2 years from the time of registration)
measure: Multiple gene profiles will be analyzed.
timeFrame: At Study Completion
measure: Measure of prostate antigen-specific immune response
timeFrame: Every 21 days during treatment. Follow-up is every 3 mo until evidence of progression or relapse for 2 years, then every 4 mo for 2 years, then every 6 mo for 2 years from the time of registration)
measure: Estimation of treatment-related toxicity
timeFrame: Every 21 days. weekly radiation therapy, Follow-up is every 3 mo until evidence of progression or relapse for 2 years, then every 4 mo for 2 years, then every 6 mo for 2 years from the time of registration
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Hematology Oncology Associates
state: Illinois
city: Chicago
country: United States
facility: Northwestern University, Northwestern Memorial Faculty Foundation
state: Illinois
Study officials:
affiliation: Northwestern University
name: John Kalapurakal, MD
role: PRINCIPAL_INVESTIGATOR
References: