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Prostate CancerPhase 2NCT00480857

Salvage Radiation Therapy and Taxotere for PSA Failure After Radical Prostatectomy

A Phase 2 study testing Docetaxel (Taxotere) in people with Prostate Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The main purpose of this study is to try to find out whether adding chemotherapy to the standard treatment for your stage of prostate cancer is more effective than the standard treatment by itself. 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 (Taxotere)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteUnited States
Study dates
Mar 2007to Jul 2014
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

  • Age ≥ 18
  • Performance Status: Karnofsky performance status ≥ 80% (Performance status is an attempt to quantify cancer patients' general well-being and activities of daily life. The Karnofsky score runs from 100 to 0, where 100 is "perfect" health and 0 is death.)
  • Has undergone prostatectomy for histologically confirmed adenocarcinoma of the prostate at least 6 weeks prior to registration. (If prostatectomy was completed at an outside facility, a University of Michigan pathology review must take place to confirm adenocarcinoma.)
  • Has biochemical evidence of failure as determined by at least two PSA measurements after prostatectomy. This must be demonstrated by an increase of at least 0.1 ng/mL between two consecutive measurements, both obtained after prostatectomy. The most recent measurement (within 28 days of registration) must be 0.3 ng/mL or greater.
  • Has undergone pelvic CT (Computerized Tomography) scan and radionuclide bone scan within 90 days prior to registration that showed no evidence of regional or distant nodal or bone metastasis.
  • Patients with pelvic or abdominal lymph nodes equivocal or questionable by imaging are eligible if the nodes are < 1.5 cm in long axis.
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  • Equivocal bone scan findings are allowed if plain films show no conclusive evidence of metastasis.
  • Hematologic Criteria: CBC (Complete Blood Count)/differential obtained within 28 days prior to registration on study, with adequate bone marrow function defined as follows:
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
  • Platelets ≥ 100,000 cells/mm3
  • Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb = 8.0 g/dl is acceptable).
  • Hepatic Criteria within 28 days prior to registration:
  • Total bilirubin < 1 x institutional upper limit of normal (ULN)
  • ALT (Alanine Transaminase), AST (Aspartate Aminotransferase), and alkaline phosphatase must be within the eligible ranges stipulated in protocol table
  • Serum creatinine < 2 x ULN
  • Both radiation oncology and medical oncology consultation prior to registration.
  • Pharmacologic androgen ablation for prostate cancer will be allowed only if given prior to prostatectomy.
  • Patient must sign study specific informed consent prior to study entry.
  • Peripheral neuropathy: must be ≤ grade 1
  • Patients must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.

Who cannot join

  • Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
  • Evidence of M1 metastatic disease
  • Pathologically positive lymph nodes or nodes > 1.5 cm on imaging
  • Prior pelvic radiotherapy that would result in overlap of radiation therapy fields or systemic cytotoxic chemotherapy.
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 5 years (for example,carcinoma in situ of the oral cavity or bladder are permissible)
  • Severe, active co-morbidity, defined as follows, active co-morbidity, defined as follows:
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  • Unstable angina and/or congestive heart failure requiring hospitalization within the 6 months prior to registration.
  • Transmural myocardial infarction within the 6 months prior to registration
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Michigan

    Ann Arbor, Michigan, 48109-5010

Other trials in United States

About this study

Official title: Salvage Radiation Therapy and Docetaxel (Taxotere) for Biochemical Failure After Radical Prostatectomy

The main purpose of this study is to try to find out whether adding chemotherapy to the standard treatment for your stage of prostate cancer is more effective than the standard treatment by itself. The kind of treatment that most physicians would consider standard for this stage of prostate cancer is radiation therapy alone, possibly in combination with hormonal therapy. In this study, all patients will receive chemotherapy and radiation therapy. It is hoped that chemotherapy will be found to provide additional benefit, but chemotherapy has significant side effects. The use of chemotherapy is experimental in prostate cancer; it needs to be tested to determine if it is beneficial and to find out more about the side effects of the two different treatments. This study is to determine the effects, good and/or bad, of adding chemotherapy to radiation therapy as "salvage" treatment for recurrent prostate cancer after surgery.

Read the detailed description

There is no treatment proven more effective for clinically localized prostate cancer than radical prostatectomy. Nonetheless, approximately 30,000 men annually in the U.S. develop recurrence of their prostate cancer after prostatectomy. Radiation therapy is commonly utilized as attempted salvage treatment for patients who develop a rising PSA (Prostate Specific Antigen) after prostatectomy and have no evidence of metastatic disease. This study is designed to determine whether concurrent chemotherapy, weekly docetaxel, and daily radiation therapy will result in improved disease control and survival rates over those obtained with radiotherapy alone in the treatment of men with biochemical recurrence after radical prostatectomy.

Conditions
Prostate Cancer
Being tested
Docetaxel (Taxotere)
Keywords
Prostate, Radiation
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 (Taxotere)Drug

    Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.

Study groups in NCT00480857
Study groupRoleWhat they receive
DocetaxelExperimentalNot described
Receives: Drug: Docetaxel (Taxotere)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Patients Alive Without Progression at 4 Years

    The primary objective is to assess the 4-year progression free proportion of patients treated with concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy among patients with biochemical recurrence after radical prostatectomy.

    Measured: 4 years

Secondary outcomes (4)

  1. Number of Patients That Achieve a Post-radiotherapy PSA Nadir of 0.1 ng/mL or Less

    To determine the rates of complete biochemical response (as defined by achievement of a post-radiotherapy PSA nadir of 0.1 ng/mL or less) after concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy.

    Measured: 4 years

  2. The Percentage of Patients That Experience at Least 1 Grade 1, 2, 3 and 4 Toxicities

    To determine the rates of toxicities among patients treated with concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy.

    G1 events are considered mild. G2 events are considered moderate G3 events are considered severe G4 events are considered life-threatening

    Measured: 4 years

  3. The Number of Patients That Experience Evidence of Local Recurrence

    The number of patients that have local disease recurrence by imaging and clinical findings.

    Measured: 4 years

  4. The Number of Patients Alive

    The number of patients alive at 4 years.

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionAug 2013
  4. Study completionJul 2014

Why it stopped: Lack of funding.

Resources

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
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00480857
Sponsor's protocol ID
UMCC 2006.066
Other IDs
HUM 7093
Status last verified
Sep 2017
First submitted
29 May 2007
Last updated
6 Oct 2017
Data monitoring committee
Yes

Publications

  • Jackson WC, Feng FY, Daignault S, Hussain M, Smith D, Cooney K, Pienta K, Jolly S, Hollenbeck B, Olson KB, Sandler HM, Ray ME, Hamstra DA. A phase 2 trial of salvage radiation and concurrent weekly docetaxel after a rising prostate-specific antigen level after radical prostatectomy. Adv Radiat Oncol. 2015 Dec 9;1(1):59-66. doi: 10.1016/j.adro.2015.11.001. eCollection 2016 Jan-Mar.

    PubMed 28799570

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel (Taxotere) in people with Prostate Cancer, run by University of Michigan Rogel Cancer 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 20 inclusion and 10 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 6 Oct 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 16 Jan 2015). 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 Alive Without Progression at 4 Years (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00480857, which also lists 1 linked publication.

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 6 Oct 2017.

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Clinical Trial NCT00480857 | AzTrials