Salvage Radiation Therapy and Taxotere for PSA Failure After Radical Prostatectomy

NCT00480857 | Terminated Phase 2 Results DMC

• 2 other identifiers: UMCC 2006.066HUM 7093
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prostate Cancer

Keywords

Prostate; Radiation

Outcome Measures

Primary Outcomes (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.

  4 years

Secondary Outcomes (4)

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

  4 years

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

  4 years

• The Number of Patients That Experience Evidence of Local Recurrence

  4 years

• The Number of Patients Alive

  4 years

Study Arms (1)

Docetaxel

EXPERIMENTAL

Drug: Docetaxel (Taxotere)

Interventions

Docetaxel (Taxotere) DRUG

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

Docetaxel

Eligibility Criteria

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

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Sanofi: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109-5010, United States

Location

Related Publications (1)

• 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.

  PMID: 28799570 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel

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

Results Point of Contact

• Title: Dr. Daniel Hamstra
• Organization: University of Michigan Comprehensive Cancer Center

dhamm@umich.edu

(734) 936-4300

Study Officials

• Daniel A. Hamstra, M.D., Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: May 29, 2007
• First Posted: May 31, 2007
• Study Start: March 1, 2007
• Primary Completion: August 1, 2013
• Study Completion: July 1, 2014
• Last Updated: October 6, 2017
• Results First Posted: January 16, 2015

Record last verified: 2017-09

Locations

US (1)