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

• Register: ClinicalTrials.gov
• Last refreshed on: 28 August 2023
• Main ID: NCT01368588
• Date of registration: 07/06/2011
• Prospective Registration: Yes
• 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: 2592
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT01368588
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Canada, Hong Kong, Israel, Singapore, Switzerland, United States

Contacts

• Name: Mack Roach, MD
• Affiliation: University of California, San Francisco

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- 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 and/or 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 CT
or 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

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

- No evidence of bone metastases (M0) on bone scan within 120 days prior to registration
(Na F PET/CT is an acceptable substitute)

- Equivocal bone scan findings are allowed if plain films (or CT or MRI) are
negative for metastasis

- Baseline serum PSA value performed with an 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:

- Ten-day period following prostate biopsy

- Following initiation of hormonal therapy

- Within 30 days after discontinuation of finasteride

- Within 90 days after discontinuation of dutasteride

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

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

- Platelet count = 100,000/mm³

- Hemoglobin (Hgb) = 8.0 g/dL (transfusion or other intervention to achieve Hgb = 8.0
g/dL is acceptable)

- No prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for
a minimum of 3 years (1,095 days) and not in the pelvis

- E.g., carcinoma in situ of the oral cavity is permissible; however, patients with
prior history of bladder cancer are not allowed

- No prior hematological (e.g., leukemia, lymphoma, or myeloma) malignancy

- No previous radical surgery (prostatectomy) or cryosurgery for prostate cancer

- No previous pelvic irradiation, prostate brachytherapy or bilateral orchiectomy

- No 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., 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.

- No severe, active co-morbidity, defined as any of the following:

- 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 (CDC) definition

- Protocol-specific requirements may also exclude immuno-compromised patients

- HIV testing is not required for entry into this protocol

- No patients who are sexually active and not willing/able to use medically acceptable
forms of contraception

- No prior allergic reaction to the hormones involved in this protocol

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer

- No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy

- No prior hormonal therapy, such as luteinizing hormone-releasing hormone (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)

- No prior pharmacologic androgen ablation for prostate cancer unless the onset of
androgen ablation is = 45 days prior to the date of registration

- No finasteride within 30 days prior to registration

- No dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration

- No prior or concurrent cytotoxic chemotherapy for prostate cancer

- Prior chemotherapy for a different cancer is allowable

- No prior radiotherapy, including brachytherapy, to the region of the study cancer that
would result in overlap of radiation therapy fields



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

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Radiation: Whole-pelvic radiotherapy (WPRT)

Radiation: radiation therapy

Primary Outcome(s)

Overall Survival [Time Frame: From date of randomization to the date of death.]

Secondary Outcome(s)

Time to "late" grade 3+ adverse events as assessed by CTCAE current version [Time Frame: From protocol treatment start date to the date of the first late grade 3+ adverse event occurring more than 30 days after the completion of radiation therapy.]

Cause-specific survival [Time Frame: From date of randomization to the date of death due to prostate cancer.]

Biochemical failure by the Phoenix definition (PSA = 2 ng/mL over the nadir PSA) [Time Frame: From date of randomization to the date of first biochemical failure by phoenix definition within 5 years of randomization.]

Assessment and comparison of Quality Adjusted Life Years (QALYs) [Time Frame: From the baseline QALYs assessment to the last week of radiation therapy (RT), 3 months post RT, 6 months post RT, 1 year post RT and 5 years post RT.]

Fatigue status as measured by the Patient-Reported Outcome Measurement Information System (PROMIS) fatigue-domain change score [Time Frame: From the date when the baseline PROMIS is completed to the last week of treatment.]

Distant metastasis-free survival [Time Frame: From date of randomization to the date of first documented distant metastasis or date of first clinical and/or radiographic appearance of disseminated disease.]

Incidence of "acute" adverse events as assessed by the Common Toxicity Criteria for Adverse Effects (CTCAE) current version [Time Frame: From protocol treatment start date to the date of first occurrence of worst severity of the adverse event

Prostate cancer-specific HRQOL change as measured by the EPIC-26 (bowel or urinary domain) [Time Frame: Date when baseline EPIC-26 completed to 6 months post radiation therapy, 1 year post radiation therapy and 5 years post radiation therapy.]

Secondary ID(s)

NCI-2011-02674

CDR0000701128

RTOG-0924

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)

NRG Oncology