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

Northwestern University

Status and phase: Withdrawn; Phase 2

Conditions: PROSTATE CANCER

Treatments: Drug: Radiation Therapy; Drug: Docetaxel and Prednisone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01087580

NU 08U3

STU0022442 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Chemotherapy alone, no radiation therapy

Experimental group

Description:

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

Treatment:

Drug: Docetaxel and Prednisone

Drug: Docetaxel and Prednisone

Chemotherapy with Radiation Therapy

Experimental group

Description:

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.

Treatment:

Drug: Docetaxel and Prednisone

Drug: Docetaxel and Prednisone

Drug: Radiation Therapy