Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2016
• Main ID: NCT02673190
• Date of registration: 29/01/2016
• Prospective Registration: No
• Primary sponsor: Radiation Therapy Oncology Group
• Public title: Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
• Scientific title: Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial
• Date of first enrolment: July 2011
• Target sample size: 2580
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02673190
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Canada, Israel, Singapore, United States

Contacts

• Name: Mack Roach
• Affiliation: NRG Oncology

Key inclusion & exclusion criteria

Inclusion Criteria:

- Pathologically (histologically or cytologically) proven diagnosis of prostatic
adenocarcinoma within 180 days of registration at moderate- to high-risk for
recurrence as determined by one of the following combinations:

- Gleason score 7-10 + T1c-T2b (palpation) + prostate-specific antigen (PSA) < 50
ng/mL (includes intermediate- and high-risk patients)

- Gleason score 6 + T2c-T4 (palpation) + PSA < 50 ng/mL OR Gleason score 6 + >=
50% (positive) biopsies + PSA < 50 ng/ml

- Gleason score 6 + T1c-T2b (palpation) + PSA > 20 ng/mL

- Patients previously diagnosed with low risk prostate cancer undergoing active
surveillance who are re-biopsied and found to have unfavorable intermediate risk
disease or favorable high risk disease according to the protocol criteria are
eligible for enrollment within 180 days of the repeat biopsy procedure

- History/physical examination (to include at a minimum digital rectal examination of
the prostate and examination of the skeletal system and abdomen) within 90 days prior
to registration

- Clinically negative lymph nodes as established by imaging (pelvic and/or abdominal
computed tomography [CT] or magnetic resonance [MR]), (but not by nodal sampling, or
dissection) within 90 days prior to registration

- Patients with lymph nodes equivocal or questionable by imaging are eligible if
the nodes are =< 1.5 cm

- No evidence of bone metastases (M0) on bone scan within 120 days prior to
registration (sodium fluoride [NaF] positron emission tomography [PET]/CT is an
acceptable substitute)

- Equivocal bone scan findings are allowed if plain films (or CT or magnetic
resonance imaging [MRI]) are negative for metastasis

- Baseline serum PSA value performed with a Food and Drug Administration (FDA)-approved
assay (e.g., Abbott, Hybritech) within 120 days prior to registration

- Study entry PSA should not be obtained during the following time frames:

- 10-day period following prostate biopsy

- Following initiation of hormonal therapy

- Within 30 days after discontinuation of finasteride

- Within 90 days after discontinuation of dutasteride

- Zubrod performance status 0-1 (unless otherwise specified)

- Absolute neutrophil count (ANC) >= 1,500/mm³

- Platelets >= 100,000/mm³

- Hemoglobin (Hgb) >= 8.0 g/dL (Note: the use of transfusion or other intervention to
achieve Hgb >= 8.0 g/dL is acceptable)

- Patient must be able to provide study specific informed consent prior to study entry

Exclusion Criteria:

- Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a
minimum of 3 years (1095 days) not in the pelvis (for example, carcinoma in situ of
the oral cavity is permissible; however, patients with prior history of bladder
cancer are not allowed); prior hematological (e.g., leukemia, lymphoma, myeloma)
malignancy not allowed

- Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer

- Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy

- Previous hormonal therapy, such as LHRH agonists (e.g., leuprolide, goserelin,
buserelin, triptorelin) or LHRH antagonist (e.g. degarelix), anti-androgens (e.g.,
flutamide, bicalutamide, cyproterone acetate), estrogens (e.g., diethylstilbestrol
[DES]), or surgical castration (orchiectomy)

- Prior pharmacologic androgen ablation for prostate cancer is allowed only if the
onset of androgen ablation (both LHRH agonist and oral anti-androgen) is =< 45 days
prior to the date of registration

- Use of finasteride within 30 days prior to registration

- Use of dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to
registration

- Previous or concurrent cytotoxic chemotherapy for prostate cancer; note that prior
chemotherapy for a different cancer is allowable

- Prior radiotherapy, including brachytherapy, to the region of the study cancer that
would result in overlap of radiation therapy fields

- Severe, active co-morbidity, defined as follows:

- 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 registration

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of
registration

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
or severe liver dysfunction

- Acquired immune deficiency syndrome (AIDS) based upon current Centers for
Disease Control and Prevention (CDC) definition; note, however, that human
immunodeficiency virus (HIV) testing is not required for entry into this
protocol; protocol-specific requirements may also exclude immuno-compromised
patients

- Patients who are sexually active and not willing/able to use medically acceptable
forms of contraception

- Prior allergic reaction to the hormones involved in this protocol

- Patients status post a negative lymph node dissection are not eligible



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Stage II Prostate Adenocarcinoma

Stage III Prostate Adenocarcinoma

Prostate Adenocarcinoma

Intervention(s)

Radiation: 3-Dimensional Conformal Radiation Therapy

Radiation: Selective External Radiation Therapy

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Other: Laboratory Biomarker Analysis

Radiation: Intensity-Modulated Radiation Therapy

Primary Outcome(s)

Overall survival [Time Frame: From the date of randomization to the date of documented death, assessed up to 16 years]

Secondary Outcome(s)

Prostate cancer-specific HRQOL change as measured by the EPIC-26 (bowel or urinary domain) (closed to patient accrual 3/9/15) [Time Frame: Up to 6 months]

Biochemical failure by the Phoenix definition (PSA >= 2 ng/mL over the nadir PSA) [Time Frame: 5 years]

Incidence of "acute" adverse events defined as the first occurrence of worst severity of the adverse event, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) current version [Time Frame: Up to 30 days after the completion of RT]

Cause-specific survival [Time Frame: From the date of randomization to the date of death due to prostate cancer, assessed up to 16 years]

Collection of paraffin-embedded tissue blocks, plasma, whole blood, serum, and urine for planned and future translational research analyses [Time Frame: Baseline]

Distant metastasis-free survival of these patients [Time Frame: From the date of randomization to the date of documented distant metastasis/clinical and/or radiographic appearance of disseminated disease, assessed up to 16 years]

Assessment and comparison of Quality Adjusted Life Years defined by the weighted sum of different time episodes added up to a total quality-adjusted survival time (closed to patient accrual 3/9/15) [Time Frame: Up to 5 years]

Fatigue status as measured by the PROMIS fatigue-domain change score (closed to patient accrual 3/9/15) [Time Frame: Up to 3 months post RT]

Time to "late" adverse events measured from the time protocol treatment started to the time of the worst late grade 3+ adverse event using the CTCAE [Time Frame: Up to 16 years after completion of study treatment]

Secondary ID(s)

PRTOG-0924_A03PAMDREVW01

NCI-2011-02674

RTOG 0924

U10CA021661

CDR0000701128

RTOG-0924

U10CA180868

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)

NRG Oncology