Investigation of a shortened radiation therapy compared to standard duration radiation therapy in prostate cancer

ICTRP Trial ID
NCT01368588 (ICTRP)

Official title (approved by ethics committee)
not available

Academic 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 (ICTRP)

Public title
Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer (ICTRP)

Disease under investigation
Prostate Cancer (ICTRP)

Intervention under investigation
Radiation: radiation therapy;Radiation: Whole-pelvic radiotherapy (WPRT) (ICTRP)

Type of trial
Interventional (ICTRP)

Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Inclusion/Exclusion criteria
Gender: Male
Maximum age: N/A
Minimum age: 18 Years
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/mm?

- Platelet count = 100,000/mm?

- 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 (ICTRP)

not available

Primary and secondary end points
Overall Survival (ICTRP)

Cause-specific survival;Distant metastasis-free survival;Biochemical failure by the Phoenix definition (PSA = 2 ng/mL over the nadir PSA);Incidence of "acute" adverse events as assessed by the Common Toxicity Criteria for Adverse Effects (CTCAE) current version;Time to "late" grade 3+ adverse events as assessed by CTCAE current version;Prostate cancer-specific HRQOL change as measured by the EPIC-26 (bowel or urinary domain);Fatigue status as measured by the Patient-Reported Outcome Measurement Information System (PROMIS) fatigue-domain change score;Assessment and comparison of Quality Adjusted Life Years (QALYs) (ICTRP)

Registration date
not available

Incorporation of the first participant
not available

Secondary sponsors
National Cancer Institute (NCI);NRG Oncology (ICTRP)

Additional contacts
Mack Roach, MD, University of California, San Francisco (ICTRP)

Secondary trial IDs
CDR0000701128, NCI-2011-02674, RTOG-0924 (ICTRP)

Results-Individual Participant Data (IPD)
No (ICTRP)

Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT01368588 (ICTRP)