Primary outcomeNumber· Up to 3 years
Proportion of Biochemical Progression-Free Survival (bPFS Proportion) at 3 Years
| Group | Value (proportion of patients) |
|---|---|
| Arm A: Docetaxel + LHRH Agonist + Surgical Intervention | 0.89 |
| Arm B: Surgical Intervention | 0.84 |
Trial · Interventional
Active, not recruitingPhase 3Results postedRegistry dataSurgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer
NCTNCT00430183 (opens ClinicalTrials.gov in a new tab)Other idCALGB 90203Other idU10CA031946Other idCDR0000526353
Overview
- Status
- Active, not recruiting
- Phase
- Phase 3
- Enrollment
- 788 participants (actual)
- Sponsor
- Alliance for Clinical Trials in Oncology · Other
- Design
- Randomized · Open label (no masking)
- Countries
2 countries
United States, Canada
- Start
- 8 May 2007
- Primary completion
- 2 Oct 2018
- Completion
- Oct 2030 (estimated)
- First posted
- 1 Feb 2007 (estimated)
- Last update posted
- 9 Feb 2023
- Conditions
- Prostate Cancer
Timeline
1 trial · 1 ongoing · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20102015202020252030
- Ph 3
Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer
NCT004301838 May 2007 to est. Oct 2030
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin and leuprolide, may stop the adrenal glands from making androgens. Giving docetaxel and leuprolide or goserelin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether giving docetaxel and leuprolide or goserelin before surgery is more effective than surgery alone in treating patients with prostate cancer. PURPOSE: This randomized phase III trial is studying docetaxel and leuprolide or goserelin to see how well they work when given before surgery compared with surgery alone in treating patients with high-risk localized prostate cancer.
Interventions
- docetaxelDrug
- LHRH agonistDrug
- surgeryProcedure
Arms2
Experimental
Arm A: docetaxel + LHRH agonist + surgical intervention
Patients receive six cycles of docetaxel administered every 3 weeks combined with 18-24 weeks of androgen deprivation therapy. During each cycle of chemotherapy, all patients should undergo premedication with dexamethasone 8 mg orally prior to docetaxel. Dexamethasone may also be given intravenously according to institutional guidelines. Patients will also receive androgen deprivation for 18-24 weeks of an LHRH agonist (eg, leuprolide acetate, goserelin acetate). Additional premedication and antiemetics may be given at the physician's discretion and as defined by the protocol. Patients will undergo standard surgical intervention. The surgical procedures will be performed within 60 days of the completion of neoadjuvant therapy. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. It must be initiated within 6 months of the date of surgery.
Other
Arm B: surgical intervention
All patients undergo standard surgical intervention. The surgical procedures will be performed within 60 days of randomization. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. Adjuvant radiation must be initiated within 6 months of the date of surgery.
Primary outcomes1
Outcomes the sponsor listed as primary.
Proportion of Biochemical Progression-Free Survival (bPFS Proportion) at 3 Years
Time frame · Up to 3 years
Registry description
Proportion of participants surviving 3 years from randomization without biochemical progression or death. bPFS was defined as the time from randomization to the date of the first documented biochemical progression or death. Progression will be defined as having experienced either of the following: a serum PSA level \> 0.2 ng/mL that increases on 2 consecutive occasions each of which is at least 3 months apart or death occurs. The time of biochemical failure is measured from the date of randomization to the date of the first PSA level \> 0.2 ng/mL.
Secondary outcomes(7)
5-year bPFS Rate
Time frame · 5 years
Registry description
Proportion of participants surviving 5 years from randomization without biochemical progression or death.
Time to Clinical Local Recurrence (The Time From Randomization to the First Biopsy-proven Recurrence in the Prostatic Bed or New Mass.)
Time frame · Up to 15 years post-randomization
Time to Metastatic Disease Progression (The Date of Randomization to Date of Evidence of Systemic Disease on Bone Scan or Cross Sectional Imaging.)
Time frame · Up to 15 years post-randomization
Unacceptable Toxicity (Grade 3 or Higher Toxicity)
Time frame · Up to 15 years post-randomization
Prostate Cancer-specific-free Survival (The Time From Randomization to the Time of Death Due to Prostate Cancer.)
Time frame · Up to 15 years post-randomization
Disease Progression
Time frame · Up to 15 years post-randomization
Overall Survival (The Date of Randomization to the Time of Death Due to Prostate Cancer.)
Time frame · Up to 15 years post-randomization
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeNumber· 5 years
5-year bPFS Rate
| Group | Value (Proportion of participants) |
|---|---|
| Arm A: Docetaxel + LHRH Agonist + Surgical Intervention | 0.81 |
| Arm B: Surgical Intervention | 0.74 |
Secondary outcome· Up to 15 years post-randomization
Time to Clinical Local Recurrence (The Time From Randomization to the First Biopsy-proven Recurrence in the Prostatic Bed or New Mass.)
| Group | Value |
|---|
Secondary outcome· Up to 15 years post-randomization
Time to Metastatic Disease Progression (The Date of Randomization to Date of Evidence of Systemic Disease on Bone Scan or Cross Sectional Imaging.)
| Group | Value |
|---|
Secondary outcome· Up to 15 years post-randomization
Unacceptable Toxicity (Grade 3 or Higher Toxicity)
| Group | Value |
|---|
Secondary outcome· Up to 15 years post-randomization
Prostate Cancer-specific-free Survival (The Time From Randomization to the Time of Death Due to Prostate Cancer.)
| Group | Value |
|---|
Secondary outcome· Up to 15 years post-randomization
Disease Progression
| Group | Value |
|---|
Secondary outcome· Up to 15 years post-randomization
Overall Survival (The Date of Randomization to the Time of Death Due to Prostate Cancer.)
| Group | Value |
|---|
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Arm A: Docetaxel + LHRH Agonist + Surgical InterventionPatients will undergo standard surgical intervention. The surgical procedures will be performed within 60 days of the completion of neoadjuvant therapy. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. It must be initiated within 6 months of the date of surgery. | 39 / 391 | 31 / 391 | 361 / 391 |
| Arm B: Surgical InterventionAll patients undergo standard surgical intervention. The surgical procedures will be performed within 60 days of randomization. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. Adjuvant radiation must be initiated within 6 months of the date of surgery (surgery: Patients undergo radical prostatectomy with staging pelvic lymphadenectomy). | 54 / 397 | 0 / 0 | 0 / 0 |
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.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedEastham JA, Heller G, Halabi S, Monk JP 3rd, Beltran H, Gleave M, Evans CP, Clinton SK, Szmulewitz RZ, Coleman J, Hillman DW, Watt CR, George S, Sanda MG, Hahn OM, Taplin ME, Parsons JK, Mohler JL, Small EJ, Morris MJ. Cancer and Leukemia Group B 90203 (Alliance): Radical Prostatectomy With or Without Neoadjuvant Chemohormonal Therapy in Localized, High-Risk Prostate Cancer. J Clin Oncol. 2020 Sep 10;38(26):3042-3050. doi: 10.1200/JCO.20.00315. Epub 2020 Jul 24. PMID 32706639
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
1. Histologic documentation - Histologic documentation of prostatic adenocarcinoma.
Patients with small cell, neuroendocrine, or transitional cell carcinomas are not eligible.
All eligible patients must have a known Gleason sum based on biopsy or TURP at the time of registration.
2. Clinically localized disease - Patients must have clinical stage T1-T3a and no radiographic evidence of metastatic disease as demonstrated by:
* EITHER CT or MRI of the abdomen and pelvis, OR endorectal MRI of the pelvis that demonstrate no nodes \> 1.5 cm. If one or more pelvic lymph node(s) measures \> 1.5 cm, a negative biopsy is required. If more than one lymph node is \> 1.5 cm, the largest or most accessible node should be biopsied.
AND
* Negative bone scan (with plain films and/or MRI and/or CT scan confirmation, if necessary). Positive PET and Prostascint scans are not considered proof of metastatic disease.
3. Determination of high-risk status: Patients must have either:
* A Kattan nomogram predicted probability of being free from biochemical progression at 5 years after surgery of \< 60%.
OR
* Prostate biopsy Gleason sum ≥ 8 (NOTE: The Kattan nomogram probability must be calculated for all patients, including those eligible based on Gleason sum ≥ 8 only.)
4. Prior treatment - No prior treatment for prostate cancer including prior surgery (excluding TURP), pelvic lymph node dissection, radiation therapy, or chemotherapy.
Patients may have received up to 4 months of androgen deprivation therapy (LHRH agonists, antiandrogens, or both) prior to being enrolled on the study.
5. Appropriate surgical candidates - Patients must be appropriate candidates for radical prostatectomy with an estimated life expectancy \> 10 years as determined by a urologist. Evidence of underlying cardiac disease should be evaluated prior to enrollment to ensure that patients are not at high risk of cardiac complications.
6. Clotting history - Patients with a history of deep venous thrombosis, pulmonary embolism, and/or cerebrovascular accident or currently requiring systemic anticoagulation are eligible provided they are determined to be candidates for radical prostatectomy.
7. ECOG performance status: 0-2
8. Age: ≥ 18 years of age
9. Required Initial Laboratory Values:
* ANC ≥ 1500/μL
* Platelet count ≥ 150,000/μL
* Creatinine ≤ 2.0 mg/dL
* Pre-registration serum PSA level ≤ 100 ng/mL
* Bilirubin ≤ 1.5XULN (2.5XULN in patients with Gilbert's disease)
* AST/ALT ≤1.5XULN
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