Prostate CancerPhase 1/2NCT00669162
Postoperative Radiation Therapy, Hormonal Therapy and Concurrent Docetaxel for High Risk Pathologic Prostate Cancer
A Phase 1/2 study testing Docetaxel, Radiation Therapy and Casodex and Zoladex (or Lupron) in people with Prostate Cancer, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
Following a radical prostatectomy and lymph node sampling, eligible patients will undergo post-operative radiation therapy, concurrent weekly docetaxel chemotherapy , and hormonal therapy (Casodex daily and Zoladex every 3 months for 2 times or Lupron 22.5 mg im every 3 months for 2 times). Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Docetaxel, Radiation Therapy and Casodex and Zoladex (or Lupron)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Apr 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Only those patients with adenocarcinoma of the prostate who have undergone a radical prostatectomy with pelvic lymph node sampling and found to have high risk non-metastatic disease with undetectable, persistent or decreasing post-operative Prostate Specific Antigen (PSA) levels, or who have subsequently experienced a rise in PSA, will be eligible for the trial as described below in the inclusion and exclusion criteria
- Histologically documented adenocarcinoma of the prostate.
- Status post radical prostatectomy with sampling of the pelvic lymph nodes with histologically confirmed adenocarcinoma of the prostate, with the patients falling into either the "adjuvant high risk group" or the "salvage high risk group" as follows:
- a) "Adjuvant High Risk Group" (undetectable, persistent or decreasing PSA levels before starting therapy) who have NO evidence of metastatic disease (i.e. no clinical symptoms or radiologic evidence) who MUST be able to start RT treatments within 6 months of radical prostatectomy with at least one of the 3 disease features:
- Pathologic tumor 2-node 0 (T2N0) disease with positive margins and Gleason score ≥8, or
- Pathologic tumor 3a-node 0 T3aN0 disease with extracapsular extension and Gleason Score ≥ 8, or
Show all 36Show fewer
- Pathologic tumor 3b-node 0 T3bN0 disease with any Gleason Score
- b) "Salvage High Risk Group" are those patients with PSA biochemical failure defined by 2 consecutive increases over baseline PSA levels at least one month apart, who have NO other evidence of metastatic disease (i.e. no clinical symptoms or radiologic evidence), and WITH AT LEAST ONE of the high risk disease features as defined below:
- Pathologic T3bN0 disease with any Gleason score, or
- Pathologic T2-3aN0 disease with Gleason score ≥ 8,
- Pathologic T2-3aN0 disease with PSA doubling time ≤10 months, or
- Pathologic T2-3aN0 disease with Pre-radiation therapy PSA level ≥1.0 ng/ml
- Neoadjuvant hormonal therapy prior to radical prostatectomy is allowed, and post-prostatectomy hormonal therapy is allowed as long as it is not within 6 months of protocol treatment
- No prior chemotherapy, or pelvic irradiation
- Karnofsky Performance Status ≥70
- Hematologic parameters must be within the following limits:
- white blood cell count (WBC) ≥ 3,000
- Platelet Count ≥ 130,000/ mm3
- Hemoglobin level ≥ 11.0 g/dl
- Creatinine ≤ 2.5 g/dl
- Normal liver function defined as the following: Total bilirubin below the upper limit of normal AND AST, ALT, and Alkaline Phosphatase must be within a defined range of eligibility as noted below:
- Alkaline Phosphatase
- ≤ ULN - eligible
- > 1x but ≤1.5x ULN - eligible
- > 2.5x but ≤ 5x ULN - eligible
- > 5x ULN - ineligible
- aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT)
- ≤ upper limit of normal (ULN) - eligible
- > 1x but ≤1.5x ULN - eligible
- > 2.5x but ≤ 5x ULN - ineligible
- > 5x ULN - ineligible
- Patients with a history of an invasive malignancy within the last 5 years are not eligible for the protocol. Patients with history of benign tumors such as a pituitary macroadenomas, meningiomas, or craniopharyngiomas are eligible as long as the benign tumor is under local control regardless of the time frame. Patients with concurrent adequately treated basal cell or squamous cell carcinoma of the skin are also eligible for the protocol.
- Patients must be informed of the investigative nature of the treatment, must give appropriate informed consent to protocol procedures and must sign an Informed Consent Documentation Form.
- Must not have concomitant medical, psychological or social circumstances which would interfere with compliance with the protocol treatment and follow-up.
- Age ≥ 18 years
- Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter, which should be for at least 6 months after the completion of protocol therapy
Who cannot join
- Patients who have received prior chemotherapy, pelvic irradiation or post-prostatectomy androgen ablation within 6 months of protocol therapy.
- Any coexisting medical condition precluding full compliance with the study.
- Patients with active infections or known infection with HIV.
- Psychological, familiar, sociological or geographical conditions which would not permit compliance with the study protocol.
- Known contraindication to dexamethasone (allergic reaction or systemic fungal infection)
- Pre-existing Grade ≥ 1 peripheral neuropathy
- Patients with a history of a hypersensitivity reaction to products containing Polysorbate 80 (Tween 80)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: A Phase I/II Trial of Post-Prostatectomy Radiation Therapy, Hormonal Therapy and Concurrent Docetaxel for High Risk Pathologic T2-T3NO (Tumor-3, Node-0) Prostate Cancer
Following a radical prostatectomy and lymph node sampling, eligible patients will undergo post-operative radiation therapy, concurrent weekly docetaxel chemotherapy , and hormonal therapy (Casodex daily and Zoladex every 3 months for 2 times or Lupron 22.5 mg im every 3 months for 2 times).
Read the detailed description
After consent, laboratory and radiologic tests will be done and a baseline questionnaire will be completed. Participants will then be started on the protocol specific hormonal therapy for a total of 6 months. After 2 months of hormone therapy the participants will begin radiation therapy and concurrent docetaxel chemotherapy treatments.
The radiation therapy will be delivered to a total dose of 66.0 Gy at 2.0 Gy/fraction (fx) once daily over 7 weeks, using either a 3-D conformal technique and/or intensity modulated radiation therapy (IMRT).
Participants will receive docetaxel once a week for a total of 7 infusions with concurrent radiation therapy treatments. The weekly dose of docetaxel will be 20 mg/m2. Docetaxel will be given as an intravenous (IV) infusion over 30 minutes within ≤6 hours prior to the radiotherapy treatments.
- Conditions
- Prostate Cancer
- Being tested
- Docetaxel, Radiation Therapy, Casodex and Zoladex (or Lupron)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere
20mg/m2 IV weekly for 7 weeks
Radiation TherapyRadiation
66.0 Gy delivered in 33 daily fractions at 2.0 Gy/fx
Casodex and Zoladex (or Lupron)Drug
Also called Bicalutaminde, Leuprolide
Casodex 50 mg po daily for 6 months, and Zoladex 10.8 mg sc q 3 mos x 2 (or Lupron 22.5 mg im q 3 mos x 2)
| Study group | Role | What they receive |
|---|---|---|
| RT, Docetaxel, Hormonal Therapy | Experimental | Radiation Therapy (RT) to 66 Gy in 33 treatment fractions at 2.0 Gy/fx Concurrent Docetaxel (with RT) at 20 mg/m2 weekly x 7 Casodex (50 mg po daily)x 6 months Zoladex (10.8 mg sc q 3 mos x 2) or Lupron (22.5 mg im q 3 mos x 2) Receives: Drug: Docetaxel; Radiation: Radiation Therapy; Drug: Casodex and Zoladex (or Lupron) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Who Can Safely Tolerate and Complete Adjuvant Hormonal Therapy, Radiation Therapy and Docetaxel After a Radical Prostatectomy
Defined as percentage of patients that complete full dose of Radiation Therapy (RT)
Measured: 8 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startAug 2012
- Primary completionAug 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinglei Shen, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669162
- Sponsor's protocol ID
- 12313
- Status last verified
- Feb 2018
- First submitted
- 24 Apr 2008
- Last updated
- 24 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Post-Prostatectomy Radiation Therapy, Hormonal Therapy and Concurrent Docetaxel for High Risk Pathologic T2-T3NO (Tumor-3, Node-0) Prostate Cancer
- ClinicalTrials.gov ID
- NCT00669162
- Acronym / sponsor ID
- 12313
- Conditions
- Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 29 Apr 2008 (estimated)
- Results
- Posted 24 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Following a radical prostatectomy and lymph node sampling, eligible patients will undergo post-operative radiation therapy, concurrent weekly docetaxel chemotherapy , and hormonal therapy (Casodex daily and Zoladex every 3 months for 2 times or Lupron 22.5 mg im every 3 months for 2 times).
Detailed description
After consent, laboratory and radiologic tests will be done and a baseline questionnaire will be completed. Participants will then be started on the protocol specific hormonal therapy for a total of 6 months. After 2 months of hormone therapy the participants will begin radiation therapy and concurrent docetaxel chemotherapy treatments.
The radiation therapy will be delivered to a total dose of 66.0 Gy at 2.0 Gy/fraction (fx) once daily over 7 weeks, using either a 3-D conformal technique and/or intensity modulated radiation therapy (IMRT).
Participants will receive docetaxel once a week for a total of 7 infusions with concurrent radiation therapy treatments. The weekly dose of docetaxel will be 20 mg/m2. Docetaxel will be given as an intravenous (IV) infusion over 30 minutes within ≤6 hours prior to the radiotherapy treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RT, Docetaxel, Hormonal Therapy | Experimental | Drug: Docetaxel, Radiation: Radiation Therapy, Drug: Casodex and Zoladex (or Lupron)Radiation Therapy (RT) to 66 Gy in 33 treatment fractions at 2.0 Gy/fx Concurrent Docetaxel (with RT) at 20 mg/m2 weekly x 7 Casodex (50 mg po daily)x 6 months Zoladex (10.8 mg sc q 3 mos x 2) or Lupron (22.5 mg im q 3 mos x 2) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- Only those patients with adenocarcinoma of the prostate who have undergone a radical prostatectomy with pelvic lymph node sampling and found to have high risk non-metastatic disease with undetectable, persistent or decreasing post-operative Prostate Specific Antigen (PSA) levels, or who have subsequently experienced a rise in PSA, will be eligible for the trial as described below in the inclusion and exclusion criteria
- Histologically documented adenocarcinoma of the prostate.
- Status post radical prostatectomy with sampling of the pelvic lymph nodes with histologically confirmed adenocarcinoma of the prostate, with the patients falling into either the "adjuvant high risk group" or the "salvage high risk group" as follows:
- Neoadjuvant hormonal therapy prior to radical prostatectomy is allowed, and post-prostatectomy hormonal therapy is allowed as long as it is not within 6 months of protocol treatment
- No prior chemotherapy, or pelvic irradiation
Key exclusion criteria (7 listed)
- Patients who have received prior chemotherapy, pelvic irradiation or post-prostatectomy androgen ablation within 6 months of protocol therapy.
- Any coexisting medical condition precluding full compliance with the study.
- Patients with active infections or known infection with HIV.
- Psychological, familiar, sociological or geographical conditions which would not permit compliance with the study protocol.
- Known contraindication to dexamethasone (allergic reaction or systemic fungal infection)
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 |
|---|---|---|
| DocetaxelAlso: Taxotere20mg/m2 IV weekly for 7 weeks | Drug | RT, Docetaxel, Hormonal Therapy |
| Radiation Therapy66.0 Gy delivered in 33 daily fractions at 2.0 Gy/fx | Radiation | RT, Docetaxel, Hormonal Therapy |
| Casodex and Zoladex (or Lupron)Also: Bicalutaminde, LeuprolideCasodex 50 mg po daily for 6 months, and Zoladex 10.8 mg sc q 3 mos x 2 (or Lupron 22.5 mg im q 3 mos x 2) | Drug | RT, Docetaxel, Hormonal Therapy |
Primary outcome
Percentage of Patients Who Can Safely Tolerate and Complete Adjuvant Hormonal Therapy, Radiation Therapy and Docetaxel After a Radical Prostatectomy
Time frame: 8 Months
Defined as percentage of patients that complete full dose of Radiation Therapy (RT)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Xinglei Shen, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Docetaxel, Radiation Therapy and Casodex and Zoladex (or Lupron) in people with Prostate Cancer, run by University of Kansas Medical Center at 1 site 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 36 inclusion and 7 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: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 24 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Patients Who Can Safely Tolerate and Complete Adjuvant Hormonal Therapy, Radiation Therapy and Docetaxel After a Radical Prostatectomy (time frame: 8 Months). 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 24 Jul 2019.