Short vs Long Course Radiotherapy for Prostate Cancer
(CONSORT-PC Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University Health Network, Toronto
Must be taking: ADT, ARAT
Disqualifiers: Prior pelvic radiotherapy, Ulcerative colitis, Crohn's, others
No Placebo Group
Prior Safety Data
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?This is a prospective, randomized phase II trial investigating if radiation treatment delivered every other day for 2 weeks has the same side effects as radiation treatment delivered once weekly for 6 weeks.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that you can be on systemic treatment like ADT (androgen deprivation therapy) with or without ARAT (androgen receptor axis-targeted therapy), and previous chemotherapy is allowed if it was completed more than 6 weeks before joining the trial.
What data supports the effectiveness of the treatment for prostate cancer?
Research shows that external beam radiation therapy is effective for early-stage prostate cancer, with outcomes similar to surgery. It is considered a standard treatment for locally advanced prostate cancer, and new techniques are improving its effectiveness and reducing side effects.
12345Is radiotherapy safe for treating prostate cancer?
Radiotherapy for prostate cancer is generally considered safe, with studies showing it is well-tolerated and has a low rate of severe side effects. Some patients may experience moderate complications, but these are relatively rare.
678910How does radiotherapy for prostate cancer differ from other treatments?
Radiotherapy for prostate cancer, specifically external beam radiation therapy, is unique because it uses high-energy rays to target and kill cancer cells, and can be administered in different schedules, such as short or long courses. Unlike surgery or hormone therapy, it is non-invasive and can be combined with hormone therapy for enhanced effectiveness, especially in advanced cases.
211121314Eligibility Criteria
Men aged 18+ with metastatic prostate cancer, either low or high volume, are eligible. They must be fit for daily activities (ECOG 0 or 1), planning to receive external beam radiation therapy (EBRT) while on hormone therapy +/- ARAT. Prior chemotherapy is okay if it was over six weeks ago. Men with active inflammatory bowel disease or conditions that rule out radiotherapy, especially prior pelvic radiation, can't join.Inclusion Criteria
I am scheduled for external beam radiation therapy.
My cancer has spread to other parts of my body, including possibly my bones or organs.
I am 18 years old or older.
+3 more
Exclusion Criteria
I have a health condition that prevents me from receiving radiotherapy.
I have had radiation therapy to my pelvic area before.
My doctor confirms I have active ulcerative colitis or Crohn's Disease.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Radiation Treatment
Participants receive radiation treatment. Arm 1: every other day for 2 weeks; Arm 2: once a week for 6 weeks
2-6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
5 years
Participant Groups
This study compares two schedules of delivering radiation treatment for metastatic prostate cancer: one group will receive treatments every other day for two weeks and the other once weekly for six weeks. The goal is to see if side effects differ between these schedules.
2Treatment groups
Experimental Treatment
Group I: Arm 2 - StandardExperimental Treatment1 Intervention
Radiation treatment (36 Gy in 6 fractions) to be delivered once a week over 6 weeks.
Group II: Arm 1 - InvestigationalExperimental Treatment1 Intervention
Radiation treatment (36 Gy in 6 fractions) to be delivered every other day over 2 weeks (excluding weekends).
Radiotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Radiation therapy for:
- Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma
🇺🇸 Approved in United States as Radiation therapy for:
- Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma
🇨🇦 Approved in Canada as Radiation therapy for:
- Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma
🇯🇵 Approved in Japan as Radiation therapy for:
- Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma
🇨🇳 Approved in China as Radiation therapy for:
- Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma
🇨🇭 Approved in Switzerland as Radiation therapy for:
- Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University Health Network, Princess Margaret HospitalToronto, Canada
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Who Is Running the Clinical Trial?
University Health Network, TorontoLead Sponsor
References
Role of radiotherapy for high risk localized prostate cancers. [2021]Management of high-risk prostate cancers is still a subject of debate, because of the lack of randomized trial comparing surgery and radiotherapy. If external beam radiotherapy is proposed, it must be associated with a long-term androgen deprivation therapy, at least 18-months. Irradiation of pelvic lymph nodes seems to improve distant metastasis-free survival and is so indicated in most of the cases. Moderate hypofractionation is not validated for pelvic lymph nodes irradiation. A combination of external beam radiotherapy and brachytherapy improved biochemical control in randomized trials without impact on survival. But this combination has been evaluated in large retrospective studies and seems to improve specific and overall survivals. An integrated boost on the MRI-defined index lesion is another way of dose escalation and improved also biochemical control. Stereotactic radiotherapy is not a validated option at this moment. For each patient, according to the extension of the disease, age, comorbidities and also his willingness, the best approach must be chosen, ideally in multidisciplinary meeting.
Long-term results after external beam radiation therapy for T1-T2 localized prostate cancer. [2022]The incidence of organ-confined and early-stage prostate cancer has increased. The external beam radiation therapy has proven to be a good therapeutic option in terms of biochemical survival and overall survival. It has been modified throughout the years; consequently, the available data on the long-term efficacy of external beam radiation therapy are difficult to compare with the commonly used improved radiation strategies. Intensity-modulated conformal radiotherapy and three-dimensional conformal radiotherapy result in better tumor control at a lower complication rate. External beam radiotherapy seems to be favored in intermediate- and high-risk groups for relapse of prostate cancer and radical prostatectomy is favored in the low-risk group. However, they score similarly in terms of general health-related quality of life after treatment.
Definitive external-beam radiotherapy versus radical prostatectomy in clinically localized high-risk prostate cancer: a retrospective study. [2020]Optimal treatment of high-risk prostate cancer remains controversial. We aimed to compare treatment outcomes of prostate cancer patients treated with definitive external-beam radiotherapy (ExRT) or radical prostatectomy (RP).
External beam radiation treatment for prostate cancer: still the gold standard. [2007]In patients with stage A (T1) and B (T2) prostate cancer with negative lymph nodes, the 10-year outcome following treatment with external beam radiation is the same as that following radical prostatectomy. The value of external beam radiation in stage C (T3,4) prostate cancer has been demonstrated by 10- and 15-year results in thousands of patients. External beam radiation has emerged as the standard against which new therapies for locally advanced prostate cancer should be compared in prospective trials. New conformal radiation techniques are expected to further improve local control and decrease the morbidity of external beam radiation.
Radiotherapy for prostatic cancer: patient selection and the impact of local control. [2019]To analyze the long-term results of external beam radiation therapy in patients under the age of sixty treated with early-stage prostate cancer. A comparison is also made between patients with early-stage, node-negative disease and those with locally advanced node-negative prostate cancer.
Impact of the duration of hormonal therapy following radiotherapy for localized prostate cancer. [2022]External-beam radiotherapy (EBRT) combined with androgen deprivation therapy (ADT) is known to provide improved survival outcomes compared with EBRT alone in the treatment of prostate cancer; however, the use of ADT has been reported to be associated with adverse events. Accordingly, the aim of the present study was to clarify the adequate duration of ADT when combined with EBRT to treat patients with high-risk localized prostate cancer, with consideration of survival outcomes and toxicity. Between 2001 and 2011, 173 patients with high-risk localized prostate cancer received ADT combined with EBRT, at a median dose of 69.6 Gy. Of these, 54 (31%) underwent short-term ADT (
Long-term results of an RTOG Phase II trial (00-19) of external-beam radiation therapy combined with permanent source brachytherapy for intermediate-risk clinically localized adenocarcinoma of the prostate. [2018]External-beam radiation therapy combined with low-doserate permanent brachytherapy are commonly used to treat men with localized prostate cancer. This Phase II trial was performed to document late gastrointestinal or genitourinary toxicity as well as biochemical control for this treatment in a multi-institutional cooperative group setting. This report defines the long-term results of this trial.
Prostate cancer: results of external irradiation. [2018]From 1975 to 1982, 205 patients with local prostate cancer were treated at the radiation oncology department, the University of Kansas Medical Center, Kansas City, Kansas. Patients' median age was 73 years. All of the patients were staged according to American Urologic staging criteria. Twenty-eight patients had stage A2 cancer, 91 patients had stage B cancer, and 86 patients had stage C cancer. All patients were treated using megavoltage radiation (dosage range: 6000 cGy to 7100 cGy). The follow-up period ranged from a minimum of 8 years to a maximum of 15 years (median: 9.4 years). The clinical local control was 96% for stage A2, 94% for stage B, and 90% for stage C disease. The overall and disease-free survival rates were 71% and 60%, respectively. Fourteen patients developed moderate complications with one patient (0.5%) requiring surgical intervention. The local control and survival rates reported in this study are comparable with surgical results, suggesting that external beam irradiation in prostate cancer is safe and effective.
Major 30-day complications after radical radiotherapy: a population-based analysis and comparison with surgery. [2009]Radiotherapy (RT) is used commonly to treat localized prostate cancer, particularly among older men and men with comorbid illnesses. Few population-based studies have reported on the rates of major short-term complications that lead to hospitalization after radiotherapy.
Radiation therapy of localized prostate cancer. [2006]External beam radiation therapy is an effective, well tolerated treatment modality for localized prostate cancer with a low rate of severe morbidity. In this retrospective analysis experience with 431 patients who have been treated with definitive radiation therapy with aim at cure is presented. Median follow-up time was 4 years (range 1-17 years). Treatment was administered with 45 mega Volt photons in all cases. Does between 60-70 Gray to the prostate and 45-50 Gray to the pelvic lymph nodes have been applied. Disease-free survival rates approaching 80% in 5 years and 53% in 10 years have been achieved for disease confined to the prostate as compared to 50% at 5 years and 27% at 10 years for extracapsular disease. The prognostic significance of various factors such as stage, grade, lymph node status, method of diagnosis, and pretreatment prostate-specific antigen value has been documented and analysed. Comparison of results with those of radical prostatectomy is discussed.
Triple course external beam radiotherapy for carcinoma of the prostate. [2019]In 1976 we began using a triple-course technique of external beam irradiation for localized carcinoma of the prostate. The treatment consisted of 2 courses of 20 Gy in 2 weeks to the pelvis and a third course of 20-25 Gy in 2-2 1/2 weeks as a boost to the prostate. A 2 week rest followed the first and second courses. The results of this treatment technique are reported on the first 50 patients who had been followed for at least 3 years. Although 96% of these patients developed bladder and/or bowel reactions, the majority of the symptoms were in the very mild to mild category, with only 2% severe reactions referrable to each organ. The incidence of late complications in this series compared favorably to those reported by other authors. Clinical local control was 96% while post-treatment needle biopsy performed on 22/50 patients yielded a negative rate of 86%. Those with Stages A and B disease had a negative biopsy rate of 94%. Three-year uncorrected disease-free survival for the whole group was 54%. This study has shown that with triple course external beam irradiation, excellent control of localized carcinoma of the prostate can be achieved with minimal acute morbidity.
Radiation therapy combined with hormone therapy for prostate cancer. [2007]Standard-dose radiation therapy has limited capacity to cure bulky and locally advanced prostate cancer. Multiple randomized trials have shown a clinical benefit to adding androgen suppression therapy to external-beam radiation therapy in several subsets of prostate cancer. These studies have made combining hormonal therapy with radiation therapy the standard of care for men with locally advanced (T3-4) and unfavorable prostate cancers (Gleason score >or=8 and/or prostate-specific antigen >20 ng/mL). The clinical impact of hormonal therapy has been seen in biochemical control, local control, distant metastases, disease-specific survival, and overall survival. If hormonal therapy is to be combined with radiation, it should be initiated before the start of radiation and continued during the radiation course rather than used only in the adjuvant setting. Typically, shorter-term hormone therapy is defined as regimens of 4 to 6 months, with longer-term hormone therapy describing durations beyond 24 months. Historically, longer-term hormone therapy was thought to have a more profound systemic effect; however, with the emerging use of hormonal therapy for less-advanced disease, the overall impact of shorter-course hormone therapy is being seen. This review will summarize trials using hormonal therapy and radiation with an emphasis on phase III studies and describe the more recent integration of hormone therapy with radiation for prostate cancer.
External beam radiotherapy as curative treatment of prostate cancer. [2013]External beam radiotherapy (RT) has been used as a curative treatment of prostate cancer for more than 5 decades, with the "modern" era emerging more than 3 decades ago. Its history is marked by gradual improvements punctuated by several quantum leaps that are increasingly driven by advancements in the computer and imaging sciences and by its integration with complementary forms of treatment. Consequently, the contemporary use of external beam RT barely resembles its earliest form, and this must be appreciated in the context of current patient care. The influence of predictive factors on the use and outcomes of external beam RT is presented, as is a selected review of the methods and outcomes of external beam RT as a single therapeutic intervention, in association with androgen suppression, or as a postoperative adjunct. Thus, the "state of the (radiotherapeutic) art" is presented to enhance the understanding of this treatment approach with the hope that this information will serve as a useful resource to physicians as they care for patients with prostate cancer.
[Role of hypofractionated radiotherapy in the treatment of prostate cancer: a review]. [2018]Radiotherapy of prostate cancers, over the last few years, has been an alternative choice to radical prostatectomy in the case of localised cancers as well as being the preferred treatment in both advanced localised cancers and those of the elderly. A conventional course of prostate radiotherapy consisting of four to five sessions a week, lasts between 7 and 8 weeks plus about one week of preparation.