NCI Community Oncology Research Program - Kansas City (NCORP-KC)
NCI Community Oncology Research Program - Kansas City (NCORP-KC)




NCI Community Oncology Research Program - Protocol Summary

NRG-GU002 - "PHASE II-III TRIAL OF ADJUVANT RADIOTHERAPY AND ANDROGEN DEPRIVATION FOLLOWING RADICAL PROSTATECTOMY WITH OR WITHOUT ADJUVANT DOCETAXEL"

The summary below serves as a brief review of the treatment plan and eligibility for the protocol.


This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
 

Please contact NCORP-KC for complete protocol information.



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GU Clinical Trial

CANCER TYPE: Prostate
RESEARCH BASE: NRG
NCT NUMBER: NCT03070886
HIPPA FORM: DOWNLOAD HIPPA FORM

Consent Form: VIEW CONSENT FORM

BRIEF DESCRIPTION

Post-prostatectomy, baseline Gleason ≥ 7, any pT, pN0 or pNX, no distant mets, adj. RT and androgen deprivation, with or without adj. docetaxel.



NOTES


Go to http://irochouston.mdanderson.org for RT credentialing requirements.

Tissue must be submitted for Decipher pathology sample analysis prior to step 2 randomization.

 

Treatment     (Supplied drug:  None)

Arm 1:

External beam radiation:  Starting 8 weeks after initiation of ADT 68.4 Gy/1.8 Gy/fraction  AND

Androgen Deprivation Therapy:  LHRH Agonist/antagonist Plus Non-Steroidal Anti-androgen (bicalutamide 50mg/day) 6 months duration

Arm 2:

External beam radiation:  Starting 8 weeks after initiation of ADT 68.4 Gy/1.8 Gy/fraction  AND

Androgen Deprivation Therapy:  LHRH Agonist/antagonist Plus Non-Steroidal Anti-androgen (bicalutamide) 6 months duration AND

Docetaxel 75mg/m2, starting 4-6 weeks after completion of radiation Day 1 of each 21-day cycle x 6 cycles



ELIGIBILITY

Step 1

  • Patients post-prostatectomy with baseline Gleason ≥ 7 (per prostatectomy pathology)
  • Baseline PSA nadir ≥ 0.2 ng/ml (post-operative value is never undetectable) obtained prior to Step 1 registration
  • Baseline testosterone level obtained post-prostatectomy and 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 within 365 days (1 year) prior to Step 1 registration and 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 HIFU prior to prostatectomy is allowed).
  • Surgical FFPE specimen must be available for submission to GenomeDx for genomic analysis on DECIPHER GRID platform (See Section 10.1.1 for details).  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.
  • Prior androgen deprivation therapy (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.
    • For example: Patients on prior LHRH analogs (post-prostatectomy), the discontinuation date should be calculated based on the expected duration of the sustained release injection, not simply the injection date of the drug. For instance, if a 22.5 mg sustained release dose of leuprolide acetate is given (3 month duration), then the expected duration of such a dose would be 90 days after the injection date. For a 7.5 mg leuprolide (1 month duration), the discontinuation date would be 30 days after the injection date.
    • Please note: Finasteride or dutasteride must be stopped before treatment starts but prior usage will not affect eligibility.
  • Pathologically 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 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 workups:
    • A 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 MRI of the abdomen and pelvis with contrast within 120 days prior to Step 1 registration
      (Please note: Lymph nodes will be considered negative (N0) if they are < 1.5 cm short axis);
    • Bone scan within 120 days prior to Step 1 registration
      (Please note: a NaF 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.).
  • Age ≥ 18
  • ECOG Performance Status of ≤ 1 within 60 days prior to Step 1 registration
  • Adequate hematologic function within 60 days prior to Step 1 registration defined as follows and based upon a CBC
    • Platelets ≥ 100,000 cell/mm3;
    • Hemoglobin ≥ 10.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10.0 g/dl is NOT allowed);
    • Absolute neutrophil count ≥ 1500 cells/mm3.
  • Adequate hepatic function within 60 days prior to Step 1 registration defined as follows:
    • AST or ALT < 1.5 x the upper limit of institutional normal
    • Total bilirubin (≤ 1.5 mg/dl) unless history of Gilbert’s syndrome
  • The patient or a legally authorized representative must provide study-specific informed consent prior to Step 1 registration.
  • No Definitive clinical or radiologic evidence of metastatic disease
  • No Prior invasive malignancy (except non-melanomatous skin cancer or other in-situ malignancies, or stage Ta bladder cancer) unless disease free for a minimum of 2 years
  • No Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • No 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 as defined in Section 3.2.6.
  • No Prior whole gland ablative therapy [i.e. cryoablation or high intensity focused ultrasound (HIFU)] for prostate cancer is not allowed
  • No Prostatectomy performed greater than 365 days (1 year) prior to Step 1 registration.
  • No 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
  • Not HIV positive with 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. This exclusion criterion is necessary because the treatments involved in this protocol may be significantly immunosuppressive.

Step 2

  • For patients who have not undergone prior Decipher analysis, submission of the specimen to GenomeDx should be as soon as possible after study registration (Step 1) as these results can take up 21 days after the specimen is received at GenomeDx. Step 2 registration must occur within 6 weeks (42 days) of Step 1 registration.  GenomeDx for Decipher analysis results must be obtained prior to proceeding and completing Step 2 randomization.





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