Radiation Therapy for Prostate Cancer
Recruiting in Palo Alto (17 mi)
Overseen byOmar Ishaq, MD
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Indiana University
Disqualifiers: Prior pelvic irradiation, prior rectal surgery, nodal or distant disease, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to evaluate the tolerability and toxicity of combining two radiation therapy methods for prostate cancer: Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT), which is an external beam radiotherapy with High Dose Rate Brachytherapy Boost (form of internal radiation where a cancer doctor implants a small plastic tube or balloon (catheter) in the tumor).
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Brachytherapy Boost, ePUHRT for prostate cancer?
The use of interstitial high-dose rate implants to boost the prostate after an initial course of external beam radiotherapy (EBRT) has been applied successfully, improving results obtained with EBRT alone. Additionally, intensity-modulated radiotherapy (IMRT) combined with brachytherapy causes fewer side effects than three-dimensional conformal radiotherapy (3D-CRT), suggesting a potential benefit in using advanced radiation techniques.
12345Is radiation therapy for prostate cancer generally safe for humans?
Radiation therapy for prostate cancer can cause some side effects, such as skin reactions and gastrointestinal or urinary issues, but these are often manageable. Modern techniques like intensity-modulated radiation therapy (IMRT) have reduced severe side effects, although some risks remain, especially with higher doses.
678910How is the ePUHRT treatment for prostate cancer different from other treatments?
The ePUHRT treatment for prostate cancer is unique because it may involve advanced radiation techniques like 3D-conformal RT and intensity-modulated RT (IMRT), which allow for higher doses of radiation to be focused on the tumor while minimizing exposure to surrounding healthy tissues. This approach can potentially improve local control rates and reduce side effects compared to traditional radiation therapies.
111121314Eligibility Criteria
This trial is for individuals with prostate cancer. Participants should be suitable for radiation therapy, but specific inclusion and exclusion criteria are not provided in the details given.Inclusion Criteria
I am able to care for myself but may not be able to do active work.
I am planning to have a high dose radiation treatment for my prostate.
My colon cancer screening is current according to American Cancer Society guidelines.
+3 more
Exclusion Criteria
My prostate symptoms are severe despite treatment.
I have had radiation therapy to my pelvic area before.
My tests show cancer has spread to my lymph nodes or other areas.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Radiation Treatment
Participants receive ePUHRT 5Gy x 5 fractions with a single HDR boost of 15Gy
2 weeks
5 visits (in-person)
Follow-up
Participants are monitored for acute grade ≥ 2 GI and GU toxicity post-treatment
3 months
Regular follow-up visits
Participant Groups
The study is testing a combination of two radiation therapies: ePUHRT (external beam radiotherapy) at high doses over five sessions, followed by a single High Dose Rate Brachytherapy Boost, which involves implanting a radioactive source inside or next to the tumor area.
1Treatment groups
Experimental Treatment
Group I: ePURT 5Gy x 5 fractions with single HDR boost of 15GyExperimental Treatment1 Intervention
Single arm non-randomized non-inferiority study exploring tolerability of ePURT 5Gy x 5 fractions delivered on noncontiguous weekdays with single HDR boost of 15Gy.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolis, IN
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Who Is Running the Clinical Trial?
Indiana UniversityLead Sponsor
References
External beam radiotherapy for prostate cancer: current position and trends. [2006]External beam radiotherapy (EBRT) for the treatment of loco-regional prostate cancer yields similar survival rates to radical prostatectomy (10-year survival: 90-95%, 60-70% and 50-60% in T1, T2 and T3-stages, respectively). Post-operative radiotherapy in high-risk prostate cancer may improve the local and distant disease-free survival of patients. Using the recently developed technology of the 3D-conformal RT and of the intensity-modulated RT (IMRT), the focalized administration of a higher radiation dose is allowed keeping exposure of surrounding normal tissues to low levels. Cytoprotection with amifostine administration before EBRT fractions may reduce the incidence of early and late radiation sequel from the bladder and rectum. The developments in radiobiology suggest that large radiotherapy fractions may be more efficacious than standard radiotherapy, so that hypofractionation of radiotherapy may further improve local control rates. The use of interstitial high-dose rate implants to boost the prostate after an initial course of EBRT has been applied successfully in various institutes, with further improvement of the results obtained with EBRT. Chemotherapeutic agents, such as docetaxel and liposomal doxorubicin, as well as novel biological agents introduced into clinical practice (i.e. anti-erbB, anti-angiogenic and apoptosis-modulating agents) have shown significant radiosensitizing activity and deserve clinical evaluation in conjunction with radiotherapy.
Intensity-modulated radiotherapy causes fewer side effects than three-dimensional conformal radiotherapy when used in combination with brachytherapy for the treatment of prostate cancer. [2015]To measure the benefits of intensity-modulated radiotherapy (IMRT) compared with three-dimensional conformal radiotherapy (3D-CRT) when used in combination with brachytherapy for the treatment of prostate cancer.
Five-year follow-up of health-related quality of life after intensity-modulated radiation therapy for prostate cancer. [2022]We evaluated health-related quality of life (HRQOL) in patients with localized prostate cancer who underwent intensity-modulated radiation therapy (IMRT) or three-field conformal radiotherapy (3DCRT).
Radiotherapy of prostate cancer: established results and new developments. [2019]Radical radiotherapy has been established as an effective modality for eradicating localised prostate cancer. No satisfactory comparisons have been made with patients treated by total prostatectomy, but in surgically staged patients with negative lymph nodes survival after radiotherapy exceeds that of an aged matched population, cancer deaths occurring in only 6-15% of patients and 85% remaining free of local recurrence after 10 years. Results are predictably less satisfactory in surgically unstaged cases and for more advanced localised presentations. Nevertheless, radical radiotherapy achieves local control of disease in the majority of patients. Improved local control may be obtained by increasing radiation dose but at the expense of increased radiation-induced side-effects. Conformal radiotherapy and combined modality treatment with the neoadjuvant or adjuvant androgen deprivation show considerable promise as novel methods to improve the therapeutic ratio, and prospective randomised studies are underway to test these approaches.
Impact of Androgen Deprivation Therapy on Sexual and Hormonal Function in Patients Receiving Radiation Therapy for Prostate Cancer. [2016]Androgen deprivation therapy (ADT) added to radiation therapy (RT) in intermediate to high risk prostate cancer negatively impacts quality of life.
Eosinophilic, polymorphic, and pruritic eruption associated with radiation therapy in two patients diagnosed with prostate cancer. [2023]We report 2 cases of EPPER diagnosed in patients who received radiation therapy and hormonal therapy for locally advanced prostate cancer. Both our patients developed this rare late toxicity, but early diagnosis and treatment of this adverse event offers a good prognosis, with no unnecessary interruptions of oncological treatment required.
Acute and Late Adverse Events Associated With Radical Radiation Therapy Prostate Cancer Treatment: A Systematic Review of Clinician and Patient Toxicity Reporting in Randomized Controlled Trials. [2022]This review aimed to determine the clinician and patient reported outcome (PRO) instruments currently usedin randomized controlled trials (RCTs) of radical radiation therapy for nonmetastatic prostate cancer to report acute and late adverse events (AEs), review the quality of methodology and PRO reporting, and report the prevalence of acute and late AEs.
Acute Toxicity of Ultrahypofractionation Compared With Moderate Hypofractionation in Prostate Cancer Treatment: A Randomized Trial. [2022]We report on the early toxic effects and quality of life of localized prostate cancer radiation therapy in a randomized trial comparing moderate hypofractionation (MHF) with ultrahypofractionation (UHF).
Ultrahypofractionated Radiotherapy versus Conventional to Moderate Hypofractionated Radiotherapy for Clinically Localized Prostate Cancer. [2022]The purpose of this study was to compare the toxicity (first endpoint) and efficacy (second endpoint) of ultrahypofractionated radiotherapy (UHF) and dose-escalated conventional to moderate hypofractionated radiotherapy (DeRT) for clinically localized prostate cancer. We compared 253 patients treated with UHF and 499 patients treated with DeRT using multi-institutional retrospective data. To analyze toxicity, we divided UHF into High-dose UHF (H-UHF; equivalent doses of 2 Gy per fraction: EQD2 > 100 Gy1.5) and low-dose UHF (L-UHF; EQD2 ≤ 100 Gy1.5). In toxicity, H-UHF elevated for 3 years accumulated late gastrointestinal and genitourinary toxicity grade ≥ 2 (11.1% and 9.3%) more than L-UHF (3% and 1.2%) and DeRT (3.1% and 4.8%, p = 0.00126 and p = 0.00549). With median follow-up periods of 32.0 and 61.7 months, the actuarial 3-year biochemical failure-free survival rates were 100% (100% and 100% in the L-UHF and H-UHF) and 96.3% in the low-risk group, 96.5% (97.1% and 95.6%) and 94.9% in the intermediate-risk group, and 93.7% (100% and 94.6%) and 91.7% in the high-risk group in the UHF and DeRT groups, respectively. UHF showed equivocal efficacy, although not conclusive but suggestive due to a short follow-up period of UHF. L-UHF using EQD2 ≤ 100 Gy1.5 is a feasible UHF schedule with a good balance between toxicity and efficacy.
Transitioning from conventional radiotherapy to intensity-modulated radiotherapy for localized prostate cancer: changing focus from rectal bleeding to detailed quality of life analysis. [2022]With the advent of modern radiation techniques, we have been able to deliver a higher prescribed radiotherapy dose for localized prostate cancer without severe adverse reactions. We reviewed and analyzed the change of toxicity profiles of external beam radiation therapy (EBRT) from the literature. Late rectal bleeding is the main adverse effect, and an incidence of >20% of Grade ≥2 adverse events was reported for 2D conventional radiotherapy of up to 70 Gy. 3D conformal radiation therapy (3D-CRT) was found to reduce the incidence to ∼10%. Furthermore, intensity-modulated radiation therapy (IMRT) reduced it further to a few percentage points. However, simultaneously, urological toxicities were enhanced by dose escalation using highly precise external radiotherapy. We should pay more attention to detailed quality of life (QOL) analysis, not only with respect to rectal bleeding but also other specific symptoms (such as urinary incontinence and impotence), for two reasons: (i) because of the increasing number of patients aged >80 years, and (ii) because of improved survival with elevated doses of radiotherapy and/or hormonal therapy; age is an important prognostic factor not only for prostate-specific antigen (PSA) control but also for adverse reactions. Those factors shift the main focus of treatment purpose from survival and avoidance of PSA failure to maintaining good QOL, particularly in older patients. In conclusion, the focus of toxicity analysis after radiotherapy for prostate cancer patients is changing from rectal bleeding to total elaborate quality of life assessment.
Developments in external beam radiotherapy for prostate cancer. [2018]Prostate cancer (PC) is a radiosensitive tumor, and external beam radiotherapy (EBRT) has gained its place in the treatment of PC. The aim of this review is to provide the physician involved in the treatment of PC an overview of the current indications of EBRT, to focus on some recent developments in EBRT, and to highlight promising new indications for EBRT.
Assessing the Optimal Timing for Early Salvage Radiation Therapy in Patients with Prostate-specific Antigen Rise After Radical Prostatectomy. [2022]Early salvage radiation therapy (eSRT) represents a treatment option for patients who experience a prostate-specific antigen (PSA) rise after radical prostatectomy (RP); however, the optimal PSA level for eSRT administration is still unclear.
Comparison of three radiotherapy modalities on biochemical control and overall survival for the treatment of prostate cancer: a systematic review. [2018]For the radiation treatment of prostate cancer high dose should be delivered for optimal biochemical control. Treatment can be given by dose-escalated external beam radiotherapy (EBRT) or external beam radiotherapy combined with a radioactive seed implantation (EBSeeds) or high-dose rate (HDR) brachytherapy (EBTI). Differences in outcome between the modalities were assessed by a systematic review.
External beam radiation therapy after radical prostatectomy: efficacy and impact on urinary continence. [2022]The efficacy of adjuvant and salvage external beam radiation (AXRT+SXRT) for prostate cancer after radical prostatectomy (RP) has been debated because of the inability to rule out systemic occult metastasis, uncertainty that radiation eradicates residual local disease and the potential of exacerbating impotency and incontinence. To characterize the effectiveness and treatment morbidity a retrospective review was performed.