Postop Hypofractionated Radiation Therapy and LHRH in Patients With Prostate Cancer

Launched by MCGILL UNIVERSITY HEALTH CENTRE/RESEARCH INSTITUTE OF THE MCGILL UNIVERSITY HEALTH CENTRE · Jan 29, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment approach for men with high-risk prostate cancer after surgery. Specifically, it is studying the effects of a combination of radiation therapy and a hormone therapy called LHRH (luteinizing hormone-releasing hormone) on patients who have had their prostate removed but may still be at risk for cancer returning. Prostate cancer can sometimes come back after surgery, especially in patients with certain high-risk features, so researchers want to see if this combined treatment can help lower the chance of that happening.

To participate in this trial, men must be aged 18 or older and have been diagnosed with high-risk prostate cancer, which means their cancer has certain features that make it more likely to return, such as positive surgical margins or a high Gleason score (a system doctors use to evaluate how aggressive the cancer is). Potential participants must also have a certain level of PSA (a blood marker for prostate cancer) and no signs of cancer spreading to the bones. Those who join will receive the treatment and be closely monitored by the medical team. This trial is currently recruiting participants, and anyone interested should talk to their doctor for more information.

Gender

MALE

Eligibility criteria

• Inclusion 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 prostatectomy as primary treatment (adjuvant group), with pathologically negative lymph nodes dissection or clinically negative lymph nodes by imaging \[pelvic and abdominal computed tomography (CT) scan, or magnetic resonance imaging (MRI)\]. Lymphadenectomy is not mandatory. Any type of prostatectomy will be permitted. For this group of patients, the PSA level at time of entry must be below 0.4 ng/ml
• • 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, or MRI or) and evidence of biochemical failure (defined as two consecutives rises of the PSA, at any PSA level). PSA upper limit post-prostatectomy must be below 2.0 ng/ml (salvage group). Any type of prostatectomy will be permitted
• • 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
• Exclusion Criteria:
• • 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