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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


Phase 2
18 Years
N/A
Not Enrolling
Male
PROSTATE CANCER.

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Estimation of progression free survival(PFS) and response rate

Outcome Description:

The primary objective is to estimate the progression free survival (PFS) and treatment response of patients with non-metastatic or oligometastatic CRPC in the two study arms of either chemotherapy alone (ARM 1) or a combination of RT and chemotherapy (ARM 2).

Outcome Time Frame:

Day one of each treatment cycle. cycles are every 21 days and at the end of post-treatment

Safety Issue:

No

Principal Investigator

John Kalapurakal, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University

Authority:

United States: Institutional Review Board

Study ID:

NU 08U3

NCT ID:

NCT01087580

Start Date:

March 2011

Completion Date:

July 2011

Related Keywords:

  • PROSTATE CANCER.
  • Prostate Cancer
  • non metastatic prostate cancer
  • oligometastatic prostate cancer
  • Prostatic Neoplasms

Name

Location

Northwestern University, Northwestern Memorial Faculty FoundationChicago, Illinois  60611
Hematology Oncology AssociatesChicago, Illinois  60611