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

NCT01087580 | Withdrawn Phase 2 DMC

• 2 other identifiers: NU 08U3STU0022442
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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

Conditions

PROSTATE CANCER

Keywords

Prostate Cancer; non metastatic prostate cancer; oligometastatic prostate cancer

Outcome Measures

Primary Outcomes (1)

• Estimation of progression free survival(PFS) and response rate

  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).

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

Secondary Outcomes (4)

• Overall survival of patients

  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)

• Multiple gene profiles will be analyzed.

  At Study Completion

• Measure of prostate antigen-specific immune response

  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)

• Estimation of treatment-related toxicity

  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

Study Arms (2)

Chemotherapy alone, no radiation therapy

EXPERIMENTAL

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

Chemotherapy with Radiation Therapy

EXPERIMENTAL

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; Drug: Radiation Therapy

Interventions

Docetaxel and Prednisone 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

Also known as: Taxotere

Chemotherapy alone, no radiation therapy

Radiation Therapy 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.

Chemotherapy with Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (2)

Hematology Oncology Associates

Chicago, Illinois, 60611, United States

Location

Northwestern University, Northwestern Memorial Faculty Foundation

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Prednisone; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Therapeutics

Study Officials

• John Kalapurakal, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2010
• First Posted: March 16, 2010
• Study Start: March 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

US (2)