intermediate risk prostate cancer MedDRA version: 12.1 Level: LLT Classification code 10026389 Term: Malignant neoplasm of prostate
Conditions
Interventions
Trade Name: Decapeptyl SR 3mg
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: TRIPTORELIN ACETATE
CAS Number: 140194-24-7
Concentration unit: mg milligram(s)
Sponsors
Radiation Therapy Oncology Group
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 3.1.1 Pathologically (histologically) proven diagnosis of prostatic adenocarcinoma within 6 months prior to registration at intermediate risk for recurrence as determined by having one or more of the following intermediate-risk features: Gleason Score 7; PSA >10 but =20; Clinical Stage T2b- T2c. 3.1.2 Clinically negative lymph nodes as established by imaging (pelvic +/- abdominal CT or MRI), nodal sampling, or dissection within 60 days prior to registration, except as noted immediately below: 3.1.2.1 Patients with a single intermediate risk factor only do not require abdominopelvic imaging, but these studies may be obtained at the discretion of the treating physician. Patients with 2 or 3 risk factors are required to undergo pelvic +/- abdominal CT or MRI. 3.1.2.2 Patients with lymph nodes equivocal or questionable by imaging are eligible without biopsy if the nodes are =1.5 cm; any node larger than this on imaging will require negative biopsy for eligibility. 3.1.3 No evidence of bone metastases (M0) on bone scan within 60 days prior to registration. 3.1.3.1 Bone scan is not required for patients enrolled with a single intermediate risk factor only, but this scan may be obtained at the discretion of the treating physician. Patients with 2 or 3 risk factors will require a negative bone scan for eligibility. 3.1.3.2 Equivocal bone scan findings are allowed if plain film x-rays are negative for metastasis. 3.1.4 History/physical examination (to include, at a minimum, digital rectal examination of the prostate and examination of the skeletal system and abdomen, and formal comorbidity assessment via the ACE-27 instrument) within 60 days prior to registration. Note: The ACE-27 is posted on the RTOG website, next to the protocol. 3.1.5 Zubrod Performance Status 0-1 3.1.6 Age = 18 3.1.7 Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 60 days prior to registration 3.1.7.1 Study entry PSA must not be obtained during the following time frames: (1) 10-day period following prostate biopsy; (2) following initiation of ADT; (3) within 30 days after discontinuation of finasteride; or (4) within 90 days after discontinuation of dutasteride. 3.1.8 CBC/differential obtained within 60 days prior to registration (for patients undergoing brachytherapy only), with adequate bone marrow function defined as follows: 3.1.8.1 Absolute neutrophil count (ANC) = 1,800 cells/mm3 3.1.8.2 Platelets = 100,000 cells/mm3 3.1.8.3 Hemoglobin = 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb = 8.0 g/dl is acceptable.) 3.1.9 Patient must be able to provide study-specific informed consent prior to study entry. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 3.2.1 Patients with all three intermediate risk factors who also have = 50% of the number of their biopsy cores positive for cancer are ineligible for this trial. 3.2.2 Prior invasive malignancy (except non-melanomatous skin cancer) or hematological (e.g., leukemia, lymphoma, myeloma) malignancy unless disease free for a minimum of 5 years (prior diagnoses of carcinoma in situ are permitted) 3.2.3 Prior radical surgery (prostatectomy), high-intensity focused ultrasound (HIFU) or cryosurgery for prostate cancer 3.2.4 Prior hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide), antiandrogens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or bilateral orchiectomy 3.2.5 Use of finasteride within 30 days prior to registration 3.2.6 Use of dutasteride within 90 days prior to registration 3.2.7 Prior or concurrent cytotoxic chemotherapy for prostate cancer; prior chemotherapy for a different cancer is permitted. 3.2.8 Prior RT, including brachytherapy, to the region of the study cancer that would result in overlap of RT fields 3.2.8.1 Any patient undergoing brachytherapy must have transrectal ultrasound confirmation of prostate volume <60 cc, AUA score =15 within 60 days of registration, and no history of prior transurethral resection of the prostate (TURP); prior TURP is permitted for patients who receive EBRT only) 3.2.9 Severe, active co-morbidity, defined as follows: 3.2.9.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months 3.2.9.2 Transmural myocardial infarction within the last 6 months 3.2.9.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration 3.2.9.4 Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration 3.2.9.5 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol. 3.2.9.6 Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. While the treatment employed in this study is not significantly immunosuppressive, it is felt that a diagnosis of AIDS associated with prostate cancer is likely to impact this study’s primary endpoint of overall survival. Patients who are HIV seropositive but do not meet criteria for diagnosis of AIDS are eligible for study participation. 3.2.10 Men who are sexually active with a woman of child-bearing potential and not willing/able to use medically acceptable forms of contraception (e.g., surgical, barrier, medicinal) during protocol treatment and during the first 3 months after cessation of protocol treatment; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate an overall survival (OS) advantage for the addition of short-term (6 months) ADT to dose-escalated RT for patients with intermediate-risk prostate cancer. The events for OS will be defined as death due to any cause.;Secondary Objective: 2.2.1 Determine whether the addition of ADT to dose-escalated RT improves clinical failures 2.2.2 Estimate the magnitude of benefit of ADT with respect to OS for patients treated with different RT modalities 2.2.3 Compare acute and late treatment adverse events 2.2.4 DeterCompare HRQoL between two groups 2.2.5 Demonstrate that the addition of ADT to dose-escalated RT is associated with higher fatigue severity 2.2.6 Demonstrate an incremental gain in OS with more aggressive therapy that outweighs the detriments in the primary generic domains of HRQOL 2.2.7 Determine whether the PROMIS score change is correlated with serum cytokine change 2.2.8 Collect paraffin-embedded tissue blocks, plasma, and buffy coat cells for future translational research analyses;Primary end point(s): Overall survival (OS): The failure event for OS will be death due to any cause (See Section 11.2.1). | — |
Countries
Ireland
Outcome results
None listed