Primary outcomeNumber· 1 Year
Number of Participants Progression Free at 1 Year
| Group | Value (participants) |
|---|---|
| Neoadjuvant Hormones + Docetaxel | 13 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataNeoadjuvant Hormones + Docetaxel in Node-Positive Prostate Cancer
NCTNCT01076335 (opens ClinicalTrials.gov in a new tab)Other id2004-0273Other idP50CA090270Other idNCI-2010-01369
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 40 participants (actual)
- Sponsor
- M.D. Anderson Cancer Center · Other
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- May 2005
- Primary completion
- Jun 2015
- Completion
- Jun 2015
- First posted
- 26 Feb 2010 (estimated)
- Last update posted
- 19 Sept 2016 (estimated)
- Conditions
- Prostate Cancer
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200620082010201220142016
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The goal of this clinical research study is to find out if a therapy using docetaxel chemotherapy with hormonal therapy taken before your scheduled surgery is beneficial to treatment of prostate cancer. The safety of this combination will also be studied.
Interventions
- Neoadjuvant Hormonal TherapyDrug
- DocetaxelDrug
Arms1
Experimental
Neoadjuvant Hormones + Docetaxel
Neoadjuvant Hormonal Therapy plus Docetaxel followed by Radical Prostatectomy
Primary outcomes1
Outcomes the sponsor listed as primary.
Number of Participants Progression Free at 1 Year
Time frame · 1 Year
Registry description
Participants prostatic specific antigen (PSA) progression-free or event-free survival (that is, freedom from treatment failure) 1 year postoperatively. Treatment failure defined as objective tumor progression during therapy or in year after surgery, confirmed postoperative PSA ⩾1 ngml - 1, or any postoperative radiation, hormonal or other systemic therapy. Participants who did not undergo surgery within 8 weeks of completing 1 year of therapy on protocol (for any reason, including participant refusal) were counted as treatment failure, as were participants whose surgery was begun and aborted.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Neoadjuvant Hormones + DocetaxelOne year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m\^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy | – | 0 / 39 | 39 / 39 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- Not stated
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
1. Patients with adenocarcinoma of the prostate that in the opinion of the surgeon could be resectable after response to systemic therapy. Ductal carcinoma variant is included.
2. All patients must be regarded as acceptable anesthetic risk for radical prostatectomy and confirm their intention to undergo radical prostatectomy at the end of the neoadjuvant therapy.
3. Zubrod performance status 2 or better.
4. All patients must have thorough tumor staging and meet one of the following criteria: a) Either lymph node biopsy or lymph node dissection demonstrating presence of lymph node metastasis. b) Pelvic or retroperitoneal lymphadenopathy \>/= 2.0 cm visualized on CT scan (biopsy is not required if \>/= 2.0 cm and in typical distribution) c) Primary tumor Gleason score \>/= 8 and serum PSA concentration \>/= 25 ng/ml, indicating high risk of occult lymph node metastases.
5. (# 4 cont'd) d) Primary tumor stage T3 and Gleason score \>/= 7, indicating high risk of occult lymph node metastases. e) Primary tumor stage T4 indicating high risk of occult lymph node metastases.
6. Prior hormonal therapy up to 6 months is permitted. No concurrent ketoconazole is permitted.
7. Patients must have adequate bone marrow function defined as an absolute peripheral granulocyte count of \> 1,500/mm\^3 and platelet count of \> 100,000/mm\^3; adequate hepatic function defined with a total bilirubin of \< 1.5 mg/dl and AST/ALT \< 2X the upper limits of normal; adequate renal function defined as serum creatinine clearance \> 40 cc/min (measured or calculated).
8. Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution.
9. All patients must be evaluated in the Department of Urology and Department of Genitourinary Medical Oncology prior to signing informed consent.
Exclusion Criteria:
1. Patients with small cell or sarcomatoid histology.
2. Patients with clinical or radiological evidence of bone or other extranodal metastasis (M1b or M1c).
3. Prior chemotherapy.
4. Patients with severe or uncontrolled intercurrent infection.
5. Patients with New York Heart Association (NYHA) Class III/IV congestive heart failure, unstable angina or history of myocardial infarction within the last 6 months.
6. Contraindications to corticosteroids.
7. Uncontrolled severe hypertension, persistently uncontrolled diabetes mellitus, oxygen-dependent lung disease, chronic liver disease or HIV infection.
8. Second malignancies (excluding non-melanoma skin cancer) unless disease-free for 3 years.
9. Overt psychosis, mental disability or otherwise incompetent to give informed consent.
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