Docetaxel + Prednisone With or Without Radiation for Castrate Resistant Prostate Cancer

NCT ID: NCT01087580

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-07-31

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.

Conditions

PROSTATE CANCER

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemotherapy alone, no radiation therapy

A) Docetaxel: 75 mg/m2 IV infusion over 1 hour on day 1 of each cycle every 21 days

B) Prednisone: 10 mg orally for 21 days after each dose of docetaxel

Group Type: EXPERIMENTAL

Docetaxel and Prednisone

Intervention Type: DRUG

A) Docetaxel: 75 mg/m2 IV infusion over 1 hour on day 1 of each cycle every 21 days B) Prednisone: 10 mg orally for 21 days after each dose of docetaxel

Chemotherapy with Radiation Therapy

A) Docetaxel: 75 mg/m2 IV infusion over 1 hour on day 1 of each cycle every 21 days B) Prednisone: 10 mg orally for 21 days after each dose of docetaxel

GROUPS 1 and 2 Whole Pelvis (45 Gy) + Prostate boost (20-25 Gy) in 1.8 Gy fractions, 5 fractions/week.

GROUPS 2 Bone metastasis (bone scan index < 1.4%): 30 Gy in 10 fractions or 35 Gy in 12 fractions.

GROUPS 1,2 Abdominal Nodes (IF POSITIVE ON CT/MRI SCAN): 45-50 Gy in 1.8 Gy fractions, 5 fractions/week.

Group Type: EXPERIMENTAL

Docetaxel and Prednisone

Intervention Type: DRUG

A) Docetaxel: 75 mg/m2 IV infusion over 1 hour on day 1 of each cycle every 21 days B) Prednisone: 10 mg orally for 21 days after each dose of docetaxel

Radiation Therapy

Intervention Type: DRUG

GROUPS 1 and 2 Whole Pelvis (45 Gy) + Prostate boost (20-25 Gy) in 1.8 Gy fractions, 5 fractions/week.

GROUPS 2 Bone metastasis (bone scan index < 1.4%): 30 Gy in 10 fractions or 35 Gy in 12 fractions.

GROUPS 1,2 Abdominal Nodes (IF POSITIVE ON CT/MRI SCAN): 45-50 Gy in 1.8 Gy fractions, 5 fractions/week.

Interventions

Docetaxel and Prednisone

A) Docetaxel: 75 mg/m2 IV infusion over 1 hour on day 1 of each cycle every 21 days B) Prednisone: 10 mg orally for 21 days after each dose of docetaxel

Intervention Type: DRUG

Docetaxel and Prednisone

A) Docetaxel: 75 mg/m2 IV infusion over 1 hour on day 1 of each cycle every 21 days B) Prednisone: 10 mg orally for 21 days after each dose of docetaxel

Intervention Type: DRUG

Radiation Therapy

GROUPS 1 and 2 Whole Pelvis (45 Gy) + Prostate boost (20-25 Gy) in 1.8 Gy fractions, 5 fractions/week.

GROUPS 2 Bone metastasis (bone scan index < 1.4%): 30 Gy in 10 fractions or 35 Gy in 12 fractions.

GROUPS 1,2 Abdominal Nodes (IF POSITIVE ON CT/MRI SCAN): 45-50 Gy in 1.8 Gy fractions, 5 fractions/week.

Intervention Type: DRUG

Other Intervention Names

Taxotere; Taxotere

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Kalapurakal, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Hematology Oncology Associates

Chicago, Illinois, United States

Northwestern University, Northwestern Memorial Faculty Foundation

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU0022442

Identifier Type: OTHER

Identifier Source: secondary_id

NU 08U3

Identifier Type: -

Identifier Source: org_study_id