Stereotactic Radiotherapy + Hormone Therapy for Prostate Cancer
(EXCALIBUR Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Jonsson Comprehensive Cancer Center
Disqualifiers: Distant metastases, Neuroendocrine carcinoma, Prior pelvic radiotherapy, Crohn's disease, others
No Placebo Group
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?This phase II trial investigates the effect of extremely hypofractionated intensity modulated stereotactic body radiotherapy in treating patients with prostate cancer that has rising prostate specific antigen (PSA) after radical prostatectomy. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
Do I need to stop my current medications for this 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 Stereotactic Radiotherapy + Hormone Therapy for Prostate Cancer?
Research shows that stereotactic ablative radiotherapy (SABR) using the CyberKnife system is effective and safe for treating intermediate- to very-high-risk prostate cancer, and it may improve survival and delay further metastases in patients with oligometastatic prostate cancer.
12345Is Stereotactic Radiotherapy with Hormone Therapy safe for prostate cancer treatment?
Stereotactic Ablative Radiotherapy (SABR) using the CyberKnife system has been shown to be generally safe for treating prostate cancer, with very few severe side effects reported. Most patients experienced only mild to moderate side effects, and no severe long-term adverse effects were observed in the studies.
15678How is the treatment Stereotactic Body Radiation Therapy (SBRT) with CyberKnife different from other prostate cancer treatments?
Stereotactic Body Radiation Therapy (SBRT) with CyberKnife is unique because it delivers highly precise radiation to prostate cancer using hundreds of non-coplanar beams, which allows for targeting the tumor while minimizing damage to surrounding healthy tissue. This precision makes it a promising option for treating various risk levels of prostate cancer, including low-risk and oligometastatic cases.
123910Eligibility Criteria
Men over 18 with prostate cancer that's come back after surgery, shown by rising PSA levels. They should have had certain adverse features at the time of surgery or found cancer in lymph nodes. No prior pelvic radiotherapy, no distant metastases, and no specific other cancers or conditions like Crohn's disease.Inclusion Criteria
I can take care of myself but may not be able to do active work.
I had surgery to remove prostate cancer.
My cancer has an intermediate or high risk based on the Decipher test.
+7 more
Exclusion Criteria
I have a history of Crohn's disease, ulcerative colitis, or ataxia telangiectasia.
I have had radiation therapy to my pelvic area before.
My cancer has spread to distant parts of my body.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo stereotactic body radiotherapy (SBRT) every other day or on consecutive days for up to 14 days. Hormonal therapy may be administered at the discretion of the treating physician.
2 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits every 3 months for the first year, and then every 6 months for up to 5 years.
5 years
Every 3 months for the first year, then every 6 months
Participant Groups
The trial is testing a high-precision radiation therapy called Stereotactic Body Radiation Therapy (SBRT) combined with Hormone Therapy to see if it can treat prostate cancer more effectively with fewer treatments and less damage to healthy tissue.
1Treatment groups
Experimental Treatment
Group I: Treatment (SBRT, hormone therapy)Experimental Treatment2 Interventions
Patients undergo SBRT every other day or on consecutive days for up to 14 days. Patients may receive hormonal therapy at the discretion of the treating physician.
Stereotactic Body Radiation Therapy is already approved in United States, European Union, Canada, Australia for the following indications:
πΊπΈ Approved in United States as Stereotactic Body Radiation Therapy for:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
πͺπΊ Approved in European Union as Stereotactic Body Radiation Therapy for:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
π¨π¦ Approved in Canada as Stereotactic Body Radiation Therapy for:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
π¦πΊ Approved in Australia as Stereotactic Body Radiation Therapy for:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, CA
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Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
References
Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. [2017]Recent clinical reports of stereotactic ablative radiotherapy (SABR) in the treatment of low-risk prostate cancer have been encouraging. Our study evaluates the efficacy and safety of SABR using the CyberKnife system for treating intermediate- to very-high-risk prostate cancer.
Survival Outcomes and Pattern of Relapse After SABR for Oligometastatic Prostate Cancer. [2022]The addition of stereotactic ablative radiotherapy (SABR) to standard of care for patients with oligometastatic prostate cancer has the potential of improving survival and delaying further metastases. The primary aim of this analysis is to report survival outcomes and pattern of recurrence of patients with hormone-sensitive (HSPC) and castrate-resistant (CRPC) oligometastatic prostate cancer treated with SABR.
Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial. [2022]Stereotactic ablative body radiotherapy (SABR) is an emerging treatment option for oligometastatic prostate cancer. However, limited prospective evidence is available.
Two versus five stereotactic ablative radiotherapy treatments for localized prostate cancer: A quality of life analysis of two prospective clinical trials. [2020]Stereotactic ablative radiotherapy (SABR) is appealing for prostate cancer (PCa) due to low Ξ±/Ξ², and increasing the dose per fraction could improve the therapeutic index and lead to a better quality of life (QOL). Here we report the outcomes of a QOL comparison between two phase II clinical trials: two vs. five fraction prostate SABR.
Dosimetric and patient correlates of quality of life after prostate stereotactic ablative radiotherapy. [2018]Initial results of Stereotactic Ablative Body Radiotherapy (SABR) in the treatment of localized prostate cancer appear promising however long-term quality of life (QOL) outcomes and dosimetric correlates are necessary.
Cyberknife Radioablation of Prostate Cancer β Preliminary Results for 400 Patients [2020]Objectives: To evaluate the tolerance and effectiveness of stereotactic ablative radiotherapy (SABR) applied in the treatment of low and intermediate risk (LR & IR) prostate cancer patients (PCP) and provide an evaluation of the level of risk group impact on treatment results. In addition, androgen deprivation therapy (ADT) usage and prostatic specific antigen (PSA) decline after SABR were assessed. Material and Methods: A total of 400 PCP (213 LR and 187 IR, including T2c) were irradiated with a CyberKnife using fd 7.25 Gy to TD 36.25 Gy. At the start of treatment, 60.3% of patients were undergoing ADT and this gradually decreased to 0% after 38 months. Follow-up was for a median of 15.0 months. Patients were monitored on SABR completion and 1, 4, 8 months later and then subsequently every 6 months. GI (Gastro-Intestinal) and GU (Genito-Urinary) acute and late adverse effects, PSA and ADT usage were evaluated. Results: Failure was noted in 9 patients (2.25%) (5 in LR and 4 in IR groups) - 4 relapses and 5 nodal metastases. No G3/4 late adverse effects (EORTC/RTOG) were observed. Some 0.5% of G3 GU and 0.3% of G3 GI acute reactions were noted respectively on the SABR completion day and one month later. The median of PSA declined 1.5 ng/ml during the first month and 0.6 ng/ml during the next three months. No impact of risk groups on treatment results was found. An impact of ADT on PSA decline was only confirmed for time point interactions. Conclusions: SABR for LR and IR PCP is a safe and effective treatment. The inclusion of T2c patients and the low percentage of IR patient failure permit us the assumption that this procedure could be utilized in the treatment of more advanced cases. The results do not allow clear definition of the impact of ADT on radioablation results in LR and IR+ T2c cases.
Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. [2022]We evaluated the effectiveness and safety of stereotactic ablative radiotherapy (SABR) delivered using Cyberknife in patients with stage I non-small-cell lung cancer.
Dose-Intensified Stereotactic Ablative Radiation for Localized Prostate Cancer. [2022]Stereotactic ablative radiation (SAbR) has been increasingly used in prostate cancer (PCa) given its convenience and cost efficacy. Optimal doses remain poorly defined with limited prospective comparative trials and long-term safety/efficacy data at higher dose levels. We analyzed toxicity and outcomes for SAbR in men with localized PCa at escalated 45 Gy in 5 fractions.
Low incidence of new biochemical and clinical hypogonadism following hypofractionated stereotactic body radiation therapy (SBRT) monotherapy for low- to intermediate-risk prostate cancer. [2022]The CyberKnife is an appealing delivery system for hypofractionated stereotactic body radiation therapy (SBRT) because of its ability to deliver highly conformal radiation therapy to moving targets. This conformity is achieved via 100s of non-coplanar radiation beams, which could potentially increase transitory testicular irradiation and result in post-therapy hypogonadism. We report on our early experience with CyberKnife SBRT for low- to intermediate-risk prostate cancer patients and assess the rate of inducing biochemical and clinical hypogonadism.
Stereotactic body radiotherapy for prostate cancer: a preliminary report. [2022]We report the results of a retrospective study of stereotactic body radiotherapy (SBRT) using a Cyberknife for prostate cancer.