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Antiandrogen Therapy and Radiation Therapy with or without Docetaxel in Treating Patients with Prostate Cancer That Has Been Removed by Surgery

Status
Active
Cancer Type
Prostate Cancer
Unknown Primary
Trial Phase
Phase II
Phase III
Eligibility
18 Years and older, Male
Study Type
Treatment
NCT ID
NCT03070886
Protocol IDs
NRG-GU002 (primary)
NRG-GU002
NCI-2016-00963
NRG-GU002
Study Sponsor
NRG Oncology

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.

Objectives

PRIMARY OBJECTIVE:
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.

EXPLORATORY OBJECTIVE:
I. To optimize quality assurance methodologies and processes for radiotherapy and imaging, with machine learning strategies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive androgen deprivation therapy comprising leuprolide acetate, goserelin acetate, degarelix, 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) over 1 hour on day 1 of every 21 days for 6 cycles 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.

Eligibility

  1. Patients post-prostatectomy with baseline Gleason >= 7 (per prostatectomy pathology)
  2. Baseline PSA prior to start of androgen deprivation therapy nadir >= 0.2 ng/ml (post-operative value is never undetectable) obtained prior to step 1 registration
  3. Baseline testosterone level obtained post-prostatectomy prior to start of androgen deprivation therapy and prior to step 1 registration
  4. Pathologically (histologically) proven diagnosis of adenocarcinoma of the prostate as confirmed at time of prostatectomy; prostatectomy must have been performed within 365 days (1 year) prior to step 1 registrationand any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted; (please note: Prior ablative treatment for benign prostatic hypertrophy or focal high-intensity focused ultrasound therapy [HIFU] prior to prostatectomy is allowed)
  5. Surgical formalin-fixed paraffin-embedded (FFPE) specimen must be available for submission to GenomeDx for genomic analysis on DECIPHER GRID platform * Please note: If a patient already has a Decipher risk score and meets all of the other eligibility criteria, the patient is eligible to be registered; however, the Decipher risk report will need to be submitted to GenomeDx for validation
  6. Prior androgen deprivation (luteinizing hormone-releasing hormone [LHRH] agonist and/or non-steroidal anti-androgen) is allowed if: * Androgen deprivation therapy was initiated within 30 days prior to study enrollment * Androgen deprivation therapy was given for = 90 days duration prior to radical prostatectomy * Please note: Finasteride or dutasteride must be stopped before treatment but should not determine eligibility
  7. Pathologically lymph node negative by pelvic lymphadenectomy (pN0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [pNx])
  8. Any pT-stage based on American Joint Committee on Cancer 7th edition eligible; study entry will be based on the following diagnostic workup: * History/physical examination within 60 days prior to step 1 registration * Negative distant metastatic workup: ** A computed tomography (CT) scan of the abdomen and pelvis (with contrast [CT without contrast is permitted if the patient is not a candidate for contrast, i.e., renal function or allergy]) or magnetic resonance imaging (MRI) of the pelvis within 120 days prior to step 1 registration; (Please note: Lymph nodes will be considered negative (NO)if they are =< 1.5 cm short axis); ** Bone scan within 120 days prior to step 1 registration; (please note: a sodium fluoride [NaF] positron emission tomography [PET]/CT is an acceptable substitute and 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; Axumin scans are not allowed for determination of eligibility [e.g. a positive Axumin can in the setting of negative bonescan and CT does not exclude a patient from being eligible for enrollment]).
  9. Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 within 60 days prior to step 1 registration
  10. Platelets >= 100,000 cell/mm^3 (within 60 days prior to step 1 registration based upon a complete blood count [CBC])
  11. Hemoglobin >= 10.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is NOT allowed) (within 60 days prior to step 1 registration based upon a CBC)
  12. Absolute neutrophil count >= 1500 cells/mm^3 (within 60 days prior to step 1 registration based upon a CBC)
  13. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 1.5 x the upper limit of normal (within 60 days prior to step 1 registration)
  14. Total bilirubin (=< 1.5 mg/dl) normal unless history of Gilbert’s syndrome (within 60 days prior to step 1 registration)
  15. The patient or a legally authorized representative must provide study-specific informed consent prior to step 1 registration
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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