Prostate CancerPhase 2NCT00348816
Docetaxel, Radiation Therapy, and Prednisone in Treating Patients Who Have Undergone Surgery For Prostate Cancer
A Phase 2 study testing docetaxel, prednisone and Radical prostatectomy in people with Prostate Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. 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, prednisone and Radical prostatectomy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to 8 Jul 2016
- Phase
- Phase 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed prostate cancer
- Prostate-specific antigen (PSA) level > 0.2 ng/mL after radical prostatectomy performed ≥ 6 weeks ago
- No lymph node-positive prostate cancer
- No documented metastatic disease
- CT scan of the abdomen and pelvis negative (within the past 6 months)
- No bone pain OR negative bone scan (within the past 6 months)
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- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- Bilirubin normal
- ALT and AST ≤ 1.5 times upper limit of normal
- Alkaline phosphatase normal
- Fertile patients must use effective contraception
- No peripheral neuropathy > grade 1
- No other malignancy within the last 5 years that could affect the diagnosis or assessment of prostate cancer
- No serious illness with a life expectancy of < 5 years
- No concurrent medical, psychological, or social circumstance that would preclude study compliance
- No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
Who cannot join
- No prior orchiectomy
- No prior chemotherapy regimen for this disease
- No prior pelvic radiotherapy
- No pre- or postoperative androgen manipulation, such as luteinizing hormone-releasing hormone agonists, antiandrogens (flutamide, bicalutamide, or nilutamide), or finasteride
- Preoperative androgen manipulation for a duration of ≤ 3 months allowed
- No prior immunotherapy
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- No prior strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium, or other systemic radioisotopes
- No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
- No concurrent herbal or alternative regimens including, but not limited to, any of the following:
- Saw palmetto
- PC-SPES
- Shark cartilage
- No other concurrent investigational agents
- No other concurrent chemotherapy, immunotherapy, or hormonal therapy (except for replacement steroids)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
About this study
Official title: A Phase II Study to Assess the Feasibility and Activity of Concomitant Radiation and Docetaxel Chemotherapy Followed by Docetaxel Chemotherapy in Prostate Cancer Patients With a Persistent or Rising PSA After Radical Prostatectomy
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Docetaxel may make tumor cells more sensitive to radiation therapy. Giving docetaxel together with radiation therapy and prednisone after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving docetaxel together with radiation therapy and prednisone works in treating patients who have undergone surgery for prostate cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the rate of prostate-specific antigen (PSA) decline and the number of patients reaching a PSA nadir of zero after treatment with chemoradiotherapy comprising docetaxel and external-beam radiotherapy followed by docetaxel and prednisone in patients with hormone-naive prostate cancer who have a persistent or rising PSA after radical prostatectomy.
Secondary
- Determine the tolerability of this regimen in these patients.
- Determine the progression-free survival, based on PSA progression, of these patients.
- Determine the overall survival of patients treated with chemoradiotherapy for rising PSA after radical prostatectomy.
- Determine if the velocity of subsequent PSA failure impacts survival of these patients.
Tertiary
- Document subsequent therapy for patients whose previous treatment has failed and if there is a response to that therapy.
Quaternary: To collect data on a contemporary cohort to those on study that received radiation alone. We will match cancer and patient characteristics to determine if the variable of chemotherapy has any impact on outcomes.
OUTLINE: Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, 36, and 43 and undergo external-beam radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
Beginning within 6 weeks after completion of chemoradiotherapy, patients receive docetaxel IV over 1 hour on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 1 month, every 4 months for 2 years, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- docetaxel, prednisone, Radical prostatectomy, Radiation therapy
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV 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.
docetaxelDrug
Also called Taxotere
Docetaxel 20mg/m2/week IV every week during standard of care radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.
prednisoneDrug
Also called prednisone oral
Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.
Radical prostatectomyProcedure or surgery
Radical prostatectomy as part of standard care
Radiation therapyRadiation
Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions.
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel (Single Arm) | Experimental | Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Prednisone 5mg twice a day Radical prostatectomy as standard of care Radiation therapy will be used as standard of care Post radiation Doxcetaxel Receives: Drug: docetaxel; Drug: prednisone; Procedure: Radical prostatectomy; Radiation: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Prostate-Specific Antigen (PSA) Decline Reported as the Number of Subjects Reaching a PSA Nadir of Zero Following the Intervention.
Subjects were followed after the intervention and monitored for PSA (Prostate Specific Antigen) decline for up to 5 years of follow-up, to determine how many had a decline and reached a PSA nadir of zero..
Measured: 5 years
Secondary outcomes (3)
Progression-free Survival Based on PSA Progression
Subjects were monitored for PSA (Prostate Specific Antigen) for up to 5 years of follow-up.
Measured: 5 years
Overall Survival
Measured: 5 years
Correlation Between Velocity of Subsequent PSA Failure and Survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2006 (estimated)
- Study startMay 2006
- Primary completion8 Jul 2016
- Study completion8 Jul 2016
Why it stopped: Loss of funding
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 The University of Texas Health Science Center at San AntonioThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory P. Swanson, MD, Study chair, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348816
- Sponsor's protocol ID
- CDR0000486733
- Other IDs
- HSC20050377H.
- Status last verified
- Apr 2017
- First submitted
- 5 Jul 2006
- Last updated
- 8 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Assess the Feasibility and Activity of Concomitant Radiation and Docetaxel Chemotherapy Followed by Docetaxel Chemotherapy in Prostate Cancer Patients With a Persistent or Rising PSA After Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT00348816
- Acronym / sponsor ID
- CDR0000486733
- Conditions
- Prostate Cancer
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of funding
- Enrolment
- 21 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- 8 Jul 2016 (actual)
- Study completion
- 8 Jul 2016 (actual)
- First posted
- 6 Jul 2006 (estimated)
- Results
- Posted 15 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Docetaxel may make tumor cells more sensitive to radiation therapy. Giving docetaxel together with radiation therapy and prednisone after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving docetaxel together with radiation therapy and prednisone works in treating patients who have undergone surgery for prostate cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the rate of prostate-specific antigen (PSA) decline and the number of patients reaching a PSA nadir of zero after treatment with chemoradiotherapy comprising docetaxel and external-beam radiotherapy followed by docetaxel and prednisone in patients with hormone-naive prostate cancer who have a persistent or rising PSA after radical prostatectomy.
Secondary
- Determine the tolerability of this regimen in these patients.
- Determine the progression-free survival, based on PSA progression, of these patients.
- Determine the overall survival of patients treated with chemoradiotherapy for rising PSA after radical prostatectomy.
- Determine if the velocity of subsequent PSA failure impacts survival of these patients.
Tertiary
- Document subsequent therapy for patients whose previous treatment has failed and if there is a response to that therapy.
Quaternary: To collect data on a contemporary cohort to those on study that received radiation alone. We will match cancer and patient characteristics to determine if the variable of chemotherapy has any impact on outcomes.
OUTLINE: Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, 36, and 43 and undergo external-beam radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
Beginning within 6 weeks after completion of chemoradiotherapy, patients receive docetaxel IV over 1 hour on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 1 month, every 4 months for 2 years, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel (Single Arm) | Experimental | Drug: docetaxel, Drug: prednisone, Procedure: Radical prostatectomy, Radiation: Radiation therapyDocetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Prednisone 5mg twice a day Radical prostatectomy as standard of care Radiation therapy will be used as standard of care Post radiation Doxcetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histologically confirmed prostate cancer
- Prostate-specific antigen (PSA) level > 0.2 ng/mL after radical prostatectomy performed ≥ 6 weeks ago
- No lymph node-positive prostate cancer
- No documented metastatic disease
- ECOG performance status 0-2
Key exclusion criteria (14 listed)
- No prior orchiectomy
- No prior chemotherapy regimen for this disease
- No prior pelvic radiotherapy
- No pre- or postoperative androgen manipulation, such as luteinizing hormone-releasing hormone agonists, antiandrogens (flutamide, bicalutamide, or nilutamide), or finasteride
- No prior immunotherapy
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: TaxotereDocetaxel 20mg/m2/week IV every week during standard of care radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD. | Drug | Docetaxel (Single Arm) |
| prednisoneAlso: prednisone oralDocetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD. | Drug | Docetaxel (Single Arm) |
| Radical prostatectomyRadical prostatectomy as part of standard care | Procedure or surgery | Docetaxel (Single Arm) |
| Radiation therapyDoses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions. | Radiation | Docetaxel (Single Arm) |
Primary outcome
Rate of Prostate-Specific Antigen (PSA) Decline Reported as the Number of Subjects Reaching a PSA Nadir of Zero Following the Intervention.
Time frame: 5 years
Subjects were followed after the intervention and monitored for PSA (Prostate Specific Antigen) decline for up to 5 years of follow-up, to determine how many had a decline and reached a PSA nadir of zero..
3 secondary outcomes
Progression-free Survival Based on PSA Progression
Time frame: 5 years
Overall Survival
Time frame: 5 years
Correlation Between Velocity of Subsequent PSA Failure and Survival
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2017.
- 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.
Gregory P. Swanson, MD study chair
The University of Texas Health Science Center at San Antonio
1 site 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, prednisone and Radical prostatectomy in people with Prostate Cancer, run by The University of Texas Health Science Center at San Antonio 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 19 inclusion and 14 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: stopped early, as of the sponsor's last update on 8 Dec 2017. 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 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?
Yes. Results are posted in the registry (first posted 15 May 2017). 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?
Rate of Prostate-Specific Antigen (PSA) Decline Reported as the Number of Subjects Reaching a PSA Nadir of Zero Following the Intervention. (time frame: 5 years). 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 8 Dec 2017.