High Risk Prostate Cancer
Conditions
Keywords
prostate cancer, Zoladex, Jewish General Hospital
Brief summary
High-risk prostate cancer is usually treated with a combination of radiation therapy and hormone therapy (ADT). Radiation destroys cancer cells, while ADT lowers testosterone, a hormone that prostate cancer cells need to grow. Together, these treatments help control the cancer. ADT is usually given for 18 to 24 months, but it can cause side effects that may affect quality of life. Some people with high-risk prostate cancer may do just as well with a shorter course of ADT. This study will identify people who are most likely to benefit from shorter treatment using imaging scans and tumor tests. It will then evaluate whether a shorter course of ADT works as well as the standard treatment while reducing long-term side effects.
Interventions
DRUGZOLADEX 10.8 mg
The purpose of the study is to identify a subset of patient that may benefit to have a shorter Zoladex treatment (12 months vs 24 months)
Sponsors
Dr. Tamim Niazi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* • Able to understand and sign informed consent form (ICF); * Males aged ≥ 18 years; * Histologically confirmed adenocarcinoma of the prostate; * Participants with high-risk prostate cancer according to either of the following: a) High-risk disease - at least one of the following: i. T3a ii. Gleason 8 or less iii. PSA ≤ 30 ng/mL iv. Gleason 9 (4+5) not more than 30% of the biopsy (e.g. a 10-needle biopsy can only have a maximum of 3 x 9 \[4+5\]); * PTEN-proficient tumor confirmed by CLIA-certified immunohistochemistry (IHC); * PSMA-PET within 90 days prior to randomization: negative for nodal or distant disease. * Candidate for definitive radiation to prostate and pelvis; * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 or Karnofsky performance status of ≥70%; * Testosterone ≥150 ng/dL or 5 nmol/L; * Adequate hematologic, renal, liver function (Hemoglobin ≥10 g/dL, Absolute Neutrophil Count ≥1.5x10⁹/L, Platelets ≥100x10⁹/L); * Judged to be medically fit for ADT and RT; * Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up. * Sexually active patients, unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation during the study treatment and for 3 months after the end of the study treatment.
Exclusion criteria
* • Prior local or systemic therapy for prostate cancer (e.g. ADT, chemotherapy or novel Androgen Receptor Inhibitors \[ARIs\]); * PSMA-PET positive nodal or distant metastases; * PTEN loss or equivocal by IHC (at least more than 50%); * Evidence of nodal or distant metastases on conventional imaging; * Prior pelvic radiation or prostate surgery interfering with RT (except biopsy/TURP); * Life expectancy \<5 years regardless of the prostate cancer; * Severe concurrent disease, infection, or co-morbidity that would make the patient inappropriate for enrollment (e.g. cardiovascular disease, hypertension, diabetes, etc); * Uncontrolled cardiovascular disease including: * Myocardial infarction within 6 months; * Unstable angina; * Congestive Heart Failure: New York Heart Association (NYHA) class III or IV; * Severe arrhythmia; * Active severe infection or immunocompromised; * Active second malignancy within 5 years with the exception of: * Non-melanoma skin cancer; * Chronic Lymphocytic Leukemia (CLL) that is stable and not actively treated; * Any condition compromising adherence to the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-year biochemical failure-free survival (bFFS) | 5 years | Time from ADT initiation to time of first occurrence of biochemical failure (per Phoenix definition: PSA nadir + 2 ng/ml) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metastasis-free survival | 5-8 years | The first occurrence of distant progression or death from ADT initiation |
| Overall survival | 5-8 years | The time from ADT initiation to the time of death from any cause. |
| Prostate cancer-specific mortality | 5-8 years | The time from ADT initiation to the time of death from prostate cancer |
| 8-year biochemical failure-free survival (bFFS) | 8 years | Time from ADT initiation to time of first occurrence of biochemical failure (per Phoenix definition: PSA nadir + 2 ng/ml) |
| Toxicity - Acute | 5 years | To determine acute toxicity due to treatment using the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 |
| Toxicity - Late | 8 years | To determine late toxicity due to treatment using the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 |
| Quality of Life - General | 5-8 years | Evaluate the impact of the treatment on the patient's quality of life using the FACT-P questionnaire |
| Quality of Life - Pain | 5-8 years | Evaluate the impact of the treatment on the patient's quality of life using the Brief Pain Inventory (BPI) questionnaire |
| Quality of Life - Fatigue | 5-8 years | Evaluate the impact of the treatment on the patient's quality of life using the Brief Fatigue Inventory (BFI) questionnaire |
| Testosterone Recuperation | 5-8 years | Time from ADT completion to the return of serum-testosterone to non-castrate or normal baseline level |
Countries
Canada
Contacts
CONTACTMélanie Criqui, PhD
CONTACTPaola Diego, Nurse
Outcome results
None listed