PROSTATE CANCERPhase 2NCT01087580
Docetaxel + Prednisone With or Without Radiation for Castrate Resistant Prostate Cancer
A Phase 2 study testing Docetaxel and Prednisone and Radiation Therapy in people with PROSTATE CANCER, run by Northwestern University at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- PROSTATE CANCER
- What is being tested?
- Docetaxel and Prednisone and Radiation Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2011to Jul 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants cannot have prior chemotherapy for prostate cancer.
- Participants cannot have prior radiation therapy to the pelvis.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hematology Oncology Associates
Chicago, Illinois, 60611
Northwestern University, Northwestern Memorial Faculty Foundation
Chicago, Illinois, 60611
About this study
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
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
Read the 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
- Being tested
- Docetaxel and Prednisone, Radiation Therapy
- Keywords
- Prostate Cancer, non metastatic prostate cancer, oligometastatic prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel and PrednisoneDrug
Also called Taxotere
- 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
Docetaxel and PrednisoneDrug
Also called Taxotere
- 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 TherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Docetaxel and Prednisone; Drug: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: 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.
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.
Measured: At Study Completion
Measure of prostate antigen-specific immune response
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.
Measured: 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
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).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study startMar 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PROSTATE CANCERStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- John Kalapurakal, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087580
- Sponsor's protocol ID
- NU 08U3
- Other IDs
- STU0022442
- Status last verified
- Mar 2017
- First submitted
- 3 Mar 2010
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01087580
- Acronym / sponsor ID
- NU 08U3
- Conditions
- PROSTATE CANCER
- Keywords
- Prostate Cancer, non metastatic prostate cancer, oligometastatic prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Mar 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 16 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy alone, no radiation therapy | Experimental | Drug: Docetaxel and PrednisoneA) 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 | Experimental | Drug: Docetaxel and Prednisone, Drug: Radiation TherapyA) 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Participants cannot have prior chemotherapy for prostate cancer.
- Participants cannot have prior radiation therapy to the pelvis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docetaxel and PrednisoneAlso: TaxotereA) 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 | Chemotherapy alone, no radiation therapy |
| Docetaxel and PrednisoneAlso: TaxotereA) 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 | Chemotherapy with Radiation Therapy |
| Radiation TherapyGROUPS 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 | Chemotherapy with Radiation Therapy |
Primary outcome
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).
4 secondary outcomes
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)
Multiple gene profiles will be analyzed.
Time frame: At Study Completion
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)
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Kalapurakal, MD principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel and Prednisone and Radiation Therapy in people with PROSTATE CANCER, run by Northwestern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.