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

• ClinicalTrials.gov Identifier: NCT01087580
• Recruitment Status: Withdrawn
• First Posted: March 16, 2010
• Last Update Posted: March 3, 2017
• Sponsor: Northwestern University
• Collaborator: Genzyme, a Sanofi Company
• Information provided by (Responsible Party): Northwestern University

Study Description

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

Condition or disease	Intervention/treatment	Phase
PROSTATE CANCER	Drug: Docetaxel and Prednisone; Drug: Radiation Therapy	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: March 2011
• Actual Primary Completion Date: July 2011
• Actual Study Completion Date: July 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	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; Other Name: Taxotere
Experimental: 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.	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; Other Name: Taxotere; 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.

Outcome Measures

Primary Outcome Measures :

1. Estimation of progression free survival(PFS) and response rate [ Time Frame: Day one of each treatment cycle. cycles are every 21 days and at the end of post-treatment ]
   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).

Secondary Outcome Measures :

1. Overall survival of patients [ Time Frame: 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) ]
   One secondary objective is to estimate the overall survival of patients with non-metastatic or oligometastatic castrate resistant prostate cancer in the two study arms of either chemotherapy alone (ARM 1) or a combination of RT and chemotherapy (ARM 2).
2. Multiple gene profiles will be analyzed. [ Time Frame: At Study Completion ]
   Gene profiles using microarray techniques will be compared in order to identify genes important in governing the response to chemotherapy and radiation therapy in non-metastatic or oligometastatic castrate resistant prostate cancer. The expression and mutation of p53 gene, expression of androgen receptor (AR), PSA and neuroendocrine differentiation in non-metastatic or oligometastatic CRPC using immunohistochemical analysis will also be studied.
3. Measure of prostate antigen-specific immune response [ Time Frame: 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) ]
   This secondary objective will determine if treatment of patients with non-metastatic or oligometastatic castrate resistant prostate therapy with chemotherapy, with or without radiation therapy, elicits prostate antigen-specific immune responses.
4. Estimation of treatment-related toxicity [ Time Frame: 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 ]
   This secondary objective will estimate the treatment-related toxicity of patients with non-metastatic or oligometastatic castrate resistant prostate cancer in the two study arms of either chemotherapy alone (ARM 1) or a combination of RT and chemotherapy (ARM 2).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Illinois

Hematology Oncology Associates

Chicago, Illinois, United States, 60611

Northwestern University, Northwestern Memorial Faculty Foundation

Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Genzyme, a Sanofi Company

Investigators

• Principal Investigator: John Kalapurakal, MD; Northwestern University

More Information

• Responsible Party: Northwestern University
• ClinicalTrials.gov Identifier: NCT01087580
• Other Study ID Numbers: NU 08U3; STU0022442 ( Other Identifier: Northwestern University IRB )
• First Posted: March 16, 2010
• Last Update Posted: March 3, 2017
• Last Verified: March 2017

Keywords provided by Northwestern University:

Prostate Cancer; non metastatic prostate cancer; oligometastatic prostate cancer

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases; Prednisone; Docetaxel; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal