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

Overview

  • Study type

    Interventional
  • Study phase

    II/III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 18-000442
    • Albert Lea, Minnesota: 18-000442
    • Mankato, Minnesota: 18-000442
    NCT ID: NCT03070886
    Sponsor Protocol Number: NRG-GU002

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility 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])
  • 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
  • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Bradley Stish, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Albert Lea, Minn.

Mayo Clinic principal investigator

Bradley Stish, M.D.

Open for enrollment

Contact information:

Alzheimer’s Disease Research Center

(507) 284-1324

Mankato, Minn.

Mayo Clinic principal investigator

Bradley Stish, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20417924

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