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New treatment option for Prostate Cancer
Official title Postop Hypofractionated Radiation Therapy and LHRH in Patients With Prostate Cancer
ClinicalTrials.gov ID: NCT04249154
What this study is testing
What is Eligard?
Eligard is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for prostate cancer.
Also referred to as Radiation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Prostate cancer is the second most common cancer among Canadian men of which approximately 20-30% present with high-risk tumour characteristic. Although surgery can be curative in patients evidencing pathological high-risk disease (extracapsular extension, seminal vesicle involvement, positive surgical margins), a large proportion will develop biochemical failure within years from the surgical procedure.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only. Healthy volunteers may be eligible.
You may be able to join if
- Histologically proven high risk (any of the following risk factors: surgical positive margins; extra-capsular extension; seminal vesicle involvement...
- Histologically proven adenocarcinoma after a radical prostatectomy with pathologically negative lymph nodes (lymphadenectomy is not mandatory) or...
- Negative bone metastases proven by bone scan. The use of proton emission tomography (PET) fluoride is allowed
- History and physical examination (including digital rectal exam) within 90 days prior of registration
- Adequate marrow reserve defined as: Hemoglobin ≥ 10 g/dl (patients may be transfused in order to achieve this level); Platelets ≥ 100 000 cells/mm3...
You likely can't join if
- Previous exposure to androgen deprivation
- Chemotherapy before or after prostatectomy
- Prior pelvic radiotherapy
- Previous malignancies (except non-melanomatous skin cancer) unless disease-free \>5 years
- Severe, active medical condition that makes the use of any of the therapies of the study not recommended
See the full eligibility criteria
- Histologically proven high risk (any of the following risk factors: surgical positive margins; extra-capsular extension; seminal vesicle involvement, Gleason score \>7) adenocarcinoma of the prostate after a radical...
- Histologically proven adenocarcinoma after a radical prostatectomy with pathologically negative lymph nodes (lymphadenectomy is not mandatory) or clinically negative lymph nodes by imaging (pelvic and abdominal CT scan...
- Negative bone metastases proven by bone scan. The use of proton emission tomography (PET) fluoride is allowed
- History and physical examination (including digital rectal exam) within 90 days prior of registration
- Adequate marrow reserve defined as: Hemoglobin ≥ 10 g/dl (patients may be transfused in order to achieve this level); Platelets ≥ 100 000 cells/mm3 and a white blood cell count of ≥ 4000 cells/ml3
- AST or ALT \<2 x the upper limit of normal
- PSA and testosterone levels within one month of registration Age ≥ 18
- Zubrod Performance Status 0-1
- Patients must sign a study-specific consent form
- Previous exposure to androgen deprivation
- Chemotherapy before or after prostatectomy
- Prior pelvic radiotherapy
- Previous malignancies (except non-melanomatous skin cancer) unless disease-free \>5 years
- Severe, active medical condition that makes the use of any of the therapies of the study not recommended
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.