Trial record 1 of 2 for:
GU002
Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery
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| ClinicalTrials.gov Identifier: NCT03070886 |
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Recruitment Status :
Recruiting
First Posted : March 6, 2017
Last Update Posted : January 29, 2019
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Sponsor:
NRG Oncology
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NRG Oncology
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Brief Summary:
This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stage I Prostate Adenocarcinoma Stage II Prostate Adenocarcinoma Stage III Prostate Adenocarcinoma | Drug: Bicalutamide Drug: Docetaxel Radiation: External Beam Radiation Therapy Drug: Flutamide Drug: Goserelin Acetate Other: Laboratory Biomarker Analysis Drug: Leuprolide Acetate Drug: Nilutamide | Phase 2 Phase 3 |
PRIMARY OBJECTIVES:
I. To assess the benefit of docetaxel as measured by improvement in freedom from progression (phase II) and subsequently metastasis free survival (phase III) when given in combination with radiation and androgen deprivation in treatment of high risk prostate cancer post-radical prostatectomy.
SECONDARY OBJECTIVES:
I. To assess overall survival. II. To assess local time to progression. III. To assess undetectable prostate-specific antigen (PSA) with a non-castrate testosterone at 2.5 years post treatment.
IV. To assess the utility of genomic profiling in making adjuvant therapy decisions post-prostatectomy.
V. To assess toxicity of docetaxel in the post-operative setting when combined with radiation and androgen deprivation therapy.
VI. To assess treatment response by genomically defined sub-groups of prostate cancer patients.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive androgen deprivation therapy comprising leuprolide acetate, goserelin acetate, bicalutamide, flutamide, or nilutamide for 6 months. Beginning 8 weeks after the start of androgen deprivation therapy, patients receive external beam radiation therapy (EBRT) for 7.5 weeks.
ARM II: Patients receive androgen deprivation therapy and EBRT as in Arm I. Within 4-6 weeks after completion of radiation therapy, patients receive docetaxel intravenously (IV) on day 1 of every 21 days for 6 courses in the absence of disease progression or unexpected toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for 3 years, and then yearly.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 612 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II-III Trial of Adjuvant Radiotherapy Following Radical Prostatectomy With or Without Adjuvant Docetaxel |
| Actual Study Start Date : | January 16, 2017 |
| Estimated Primary Completion Date : | May 2026 |
| Estimated Study Completion Date : | May 2031 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Prostate cancer
Drug Information available for:
Docetaxel
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Arm I (androgen deprivation therapy, EBRT)
Patients receive androgen deprivation therapy comprising leuprolide acetate, goserelin acetate, bicalutamide, flutamide, or nilutamide for 6 months. Beginning 8 weeks after the start of androgen deprivation therapy, patients receive EBRT for 7.5 weeks.
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Drug: Bicalutamide
Given orally
Other Names:
Radiation: External Beam Radiation Therapy Undergo external beam radiation therapy
Other Names:
Drug: Flutamide Other Names:
Drug: Goserelin Acetate Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Drug: Leuprolide Acetate Other Names:
Drug: Nilutamide Other Names:
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Experimental: Arm II (androgen deprivation therapy, EBRT, docetaxel)
Patients receive androgen deprivation therapy and EBRT as in Arm I. Within 4-6 weeks after completion of radiation therapy, patients receive docetaxel IV on day 1 of every 21 days for 6 courses in the absence of disease progression or unexpected toxicity.
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Drug: Bicalutamide
Given orally
Other Names:
Drug: Docetaxel Given IV
Other Names:
Radiation: External Beam Radiation Therapy Undergo external beam radiation therapy
Other Names:
Drug: Flutamide Other Names:
Drug: Goserelin Acetate Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Drug: Leuprolide Acetate Other Names:
Drug: Nilutamide Other Names:
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Primary Outcome Measures :
- Freedom from progression (FFP) (Phase II) [ Time Frame: From time of randomization to first event, assessed up to 43 months ]Will be determined with a one-sided stratified log-rank test when 89 FFP events have been observed. Both unadjusted and adjusted hazard ratios and the respective 95% confidence interval will be computed. Events for FFP will be the first occurrence of biochemical failure by PSA >= 0.4 ng/ml over the nadir PSA confirmed by a second PSA higher than the first by any amount, recurrence (local, regional or distant), institution of secondary androgen deprivation therapy and death from any cause.
- Metastasis free survival (MFS) (Phase III) [ Time Frame: From time of randomization to first occurrence of distant metastasis or death from any cause, assessed up to 9.5 years ]Will be measured with a one-sided stratified log-rank test when 282 MFS events have been observed. Both unadjusted and adjusted hazard ratios and the respective 95% confidence interval will be computed.
Secondary Outcome Measures :
- Overall survival [ Time Frame: Time to death from any cause assessed up to 9.5 years ]Will be analyzed using log-rank methodology and Cox proportional models. Tests for violations of proportionality will performed for the survival models. Both unadjusted and adjusted hazard ratios and the respective 95% confidence interval will be computed.
- Time to local progression [ Time Frame: Baseline to local or regional recurrence ignoring biochemical failure and distant recurrence and censoring for death, assessed up to 2.5 years ]Data will be summarized by cumulative incidence curves. Fine and Gray models will be used to adjust inference for competing risks. Both unadjusted and adjusted hazard ratios and the respective 95% confidence intervals will be computed.
- Proportions of patients with Grade 3 through Grade 5 adverse events that are either related to study drug or not graded according to NCI CTCAE version 3.0 [ Time Frame: Up to 30 days post radiation therapy ]Frequencies, proportions and severity of acute adverse events by treatment arm will be presented. Specifically, Grade 3 - 5 adverse events will be tallied. Adverse events related to study drug will also be tallied.
- Proportion of undetectable PSA with a non-castrate testosterone [ Time Frame: At 2.5 years post treatment ]Both unadjusted and adjusted odds ratios and the respective 95% confidence interval will be computed.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients post-prostatectomy with baseline Gleason >= 7 (per prostatectomy pathology) and baseline PSA nadir >= 0.2 ng/ml obtained prior to step 1 registration
- Baseline testosterone level obtained post prostatectomy prior to step 1 registration
- Pathologically (histologically) proven diagnosis of adenocarcinoma of the prostate as confirmed at time of prostatectomy; prostatectomy must have been performed =< 365 days (1 year) prior to step 1 registration
- Primary treatment with radical prostatectomy
- Any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted
- Prior ablative treatment for treatment of benign prostatic hypertrophy or focal high-intensity focused ultrasound therapy (HIFU) prior to prostatectomy is allowed
- Prior androgen deprivation (luteinizing hormone-releasing hormone [LHRH] agonist and/or non-steroidal anti-androgen) is allowed if discontinued at least 90 days prior to study enrollment and given for =< 90 days duration; finasteride or dutasteride must be stopped before treatment but should not determine eligibility; for patients on prior LHRH analogs, the discontinuation date should be calculated based the expected duration of the sustained release injection, not simply the injection date of the drug
- Pathologically proven to be lymph node negative by pelvic lymphadenectomy (pN0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [pNx])
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Any pT-stage based on American Joint Committee on Cancer 7th edition is acceptable for study entry based on the following diagnostic workup:
- History/physical examination within 60 days prior to step 1 registration
- No distant metastases, based upon the following minimum diagnostic workup:
- A computed tomography (CT) scan of the abdomen and pelvis (with contrast if renal function is acceptable; a CT without contrast is permitted if the patient is not a candidate for contrast) or magnetic resonance imaging (MRI) of the pelvis within 120 days prior to step 1 registration; lymph nodes will be non-metastatic unless they measure more than 1.5 cm short axis;
- Bone scan within 120 days prior to step 1 registration (a sodium fluoride [NaF] positron emission tomography/computed tomography [PET/CT] is an acceptable substitute); if the bone scan is suspicious, a plain x-ray, CT scan, NaF PET/CT and/or MRI must be obtained to rule out metastasis
- Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 within 90 days prior to step 1 registration
- Platelets >= 1 X 10^6 cells/mm^3 (100,000) based upon complete blood count (CBC)
- Hemoglobin >= 10.0 g/dl based upon CBC (Note: The use of transfusion or other intervention to achieve Hgb >= 10.0 g/dl is not allowed)
- Absolute neutrophil count greater than 1.5 x 10^9/L (1500)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 1.5 x the upper limit of normal
- Total bilirubin normal unless history of Gilbert's syndrome
- The patient or a legally authorized representative must provide study-specific informed consent prior to step 1 registration
- Available surgical formalin-fixed paraffin-embedded (FFPE) specimen for genomic analysis on DECIPHER Genomic Resource Information Database (GRID) platform
Exclusion Criteria:
- Definitive clinical or radiologic evidence of metastatic disease
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years) Ta bladder cancer is not considered invasive
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if completed more than two years prior to step 1 registration; prior androgen deprivation is allowed
- Prior whole gland ablative therapy (i.e. cryoablation or high intensity focused ultrasound [HIFU]) for prostate cancer is allowed; prior focal HIFU or treatment for benign prostatic hypertrophy is allowed
- Prostatectomy performed greater than 365 days (1 year) prior to step 1 registration
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Severe and/or active co-morbidity defined as follows:
- History of inflammatory bowel disease
- History of active hepatitis B or C; blood tests are not required to determine if the patient has had hepatitis B or C, unless the patient reports a history of hepatitis
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 1 registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within 15 days of step 1 registration or precluding study therapy at the time of step 1 registration
- Uncontrolled severe illness or medical condition (including uncontrolled diabetes), which in the judgment of the treating physician would make the administration of chemotherapy inadvisable
- Concurrent or planned treatment with strong inhibitors (e.g. ketoconazole, clarithromycin, etcetera [etc]) or strong inducers (e.g. carbamazepine, phenytoin, rifampin, phenobarbital, efavirenz, tipranavir, St. John's wort) of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments)
- Human immunodeficiency virus (HIV) positive with cluster of differentiation 4 (CD4) count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to step 1 registration; note also that HIV testing is not required for eligibility for this protocol
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070886
Contacts
| Contact: Mark Hurwitz, MD | 215-955-5485 | mark.hurwitz@jeffersonhospital.org |
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Sponsors and Collaborators
NRG Oncology
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Mark Hurwitz, MD | NRG Oncology |
| Responsible Party: | NRG Oncology |
| ClinicalTrials.gov Identifier: | NCT03070886 History of Changes |
| Other Study ID Numbers: |
NRG-GU002 NCI-2016-00963 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) NRG-GU002 NRG-GU002 ( Other Identifier: NRG Oncology ) U10CA180868 ( U.S. NIH Grant/Contract ) |
| First Posted: | March 6, 2017 Key Record Dates |
| Last Update Posted: | January 29, 2019 |
| Last Verified: | January 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
| Product Manufactured in and Exported from the U.S.: | No | |
Additional relevant MeSH terms:
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Adenocarcinoma Prostatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases Docetaxel Leuprolide Goserelin Bicalutamide |
Flutamide Nilutamide Androgens Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Fertility Agents, Female Fertility Agents Reproductive Control Agents Antineoplastic Agents, Hormonal |