Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Proton beam

Thomas Pisansky, MD

Stereotactic ablative body radiotherapy (SABR), or stereotactic body radiotherapy (SBRT), is a specialized form of radiotherapy used to treat prostate cancer with five treatments over two weeks, compared with a conventional eight-week or longer treatment course. The purpose of this trial is to investigate the effect that proton-based SABR has on quality-of-life in patients with localized prostate cancer. The evaluation and treatment will otherwise follow standard of care, and is not considered investigational.

Patients with low-risk or intermediate-risk, clinically localized prostate cancer will be evaluated according to standard of care medical practices. The evaluation includes history and examination, prostate-specific antigen (PSA) blood testing, and review of the prior prostate biopsy pathology report; radiology scans (for example, computed tomography \[CT\], magnetic resonance imaging \[MRI\], radionuclide bone scan) may be done also; recently completed testing may not need to be repeated. Small markers will be placed in the prostate to guide the proton beam stereotactic ablative body radiotherapy (SABR) treatments, and a hydrogel spacer may also be placed between the prostate and the rectum to push the rectum away from the prostate; the hydrogel spacer will dissolve a few months later. Participants will receive five (5) proton SABR treatments over a two (2) week time period. The study will have participants complete a quality-of life questionnaire and be evaluated for side-effects before starting SABR, at the end of SABR, at three (3), six (6) and 12 months after SABR, and then yearly for five (5) years. Evaluation of the cancer status will follow standard of care practices for at least ten (10) years.

Proton-Based Stereotactic Ablative Body Radiotherapy for Prostate Cancer

Proton-Based Stereotactic Ablative Body Radiotherapy (SABR) for Select Patients With Clinically Localized Prostate Cancer.

Mayo Clinic

Symptoms and General Pathology

Neoplasm Metastasis

Neoplastic Processes

The total dose and number of fractions will depend on the site of disease. Treatment will be given daily, or every other day, over 1 -3 weeks

Stereotactic Ablative Body Radiotherapy

Robert Olson, MD

This is a study measuring toxicity while making observations about the survival benefits of treating participants with oligometastatic disease using stereotactic ablative radiotherapy (SABR).

To assess quality of life and side effects in participants with up to 5 metastatic cancer lesions treated with a comprehensive oligometastatic SABR treatment program. Secondarily, the investigators will document the disease free and overall survival.

Rationale:

The oligometastatic state was first defined in 1995 and refers to a stage of disease where cancer has spread beyond the site of origin, but is not yet widely metastatic. In such a state of limited metastatic disease, it is hypothesized that eradication of all sites of metastatic disease could result in long-term survival, or even cure, in some participants. Ablation of metastatic deposits can be achieved through several techniques, including surgery, radiofrequency ablation (RFA), or through Stereotactic ablative body radiotherapy (SABR), a new radiotherapy technology that delivers very large, hypofractionated doses of radiotherapy to small tumor targets, with high rates of local control.

Clinical evidence to support the presence of an oligometastatic state is controversial. However, there is emerging low quality evidence in both the surgical and SABR literature that this state may exist. In a study of over 5200 participants with lung metastases who underwent surgical resection, a 5-year survival of 36% was reported in participants who achieved a complete resection, much higher than would be expected for stage IV disease.3 Similarly, in participants treated with SABR for 1-3 lung metastases from a variety of primary tumors, local control with SABR was 96% at 2-years, and 2-year survival was 39%. Long-term survival has been demonstrated in participants treated for oligometastases with surgery or SABR at several other tumor sites, including liver, brain, bone, and adrenal metastases. The risk of further metastases after ablative treatment is up to 60-80% in some studies. SABR can also be used for further salvage at newly progressive sites (oligoprogression).

Despite the apparent achievement of long-term survival with ablative treatment for oligometastatic disease, the level of evidence to support such treatments is weak, often based on single-arm studies without appropriate controls. Participants included in such reports are highly selected, based on good performance status and slow pace of tumor progression. It has been suggested that the long-term survival achieved with treatment of oligometastases is a result of the selection of fit participants with very slow-growing tumors, rather than the result of treatment intervention.

Randomized trials are therefore necessary to establish the utility of ablative treatment of oligometastatic disease, and therefore the BCCA oligometastatic SABR group, recommends that participants be considered for a randomized control before being offered SABR on this current trial. In some circumstances, participants may not be comfortable with this approach, or their physicians do not have clinical equipoise, and therefore SABR for oligometastatic disease may be appropriate. BCCA has decided that given the limited evidence for SABR in this setting, it will not be offered off trial. The main focus of this trial is to assess the side effects and quality of life post SABR. This trial aims to provide a clear informed consent process, including the limited evidence for SABR off trial, and potential harm from SABR, for participants opting to pursue SABR for oligometastases.

This is a non-randomized phase II trial where all participants will receive experimental SABR to all sites of metastatic disease. The investigators will accrue 200 participants to assess toxicity associated with this experimental treatment.

Stereotactic Ablative Body Radiotherapy (SABR) for Oligometastases

Phase II Non-randomized Trial of Stereotactic Ablative Radiotherapy (SABR) for Oligometastases

Measuring percentage change in patient reported QoL before and after SABR treatment

Defined as time until death from any cause

Defined as time to either progression or death

Assessed retrospectively using RECIST criteria

British Columbia Cancer Agency

Radiation Oncologist

The prescription dose of this study will be 40 Gy in 5 fractions assigned to PTV_4000 which permits sparing of the rectum, urethra and pudendal artery. There will be a secondary dose level of 36.25 Gy in 5 fractions. A minimum dose of 36.25 Gy will be given to the entire prostate PTV_3625. 36.25 Gy in five fractions is currently endorsed as a standard of care for localized prostate cancer by the National Comprehensive Cancer Network guidelines in prostate cancer. Escalating the therapeutic radiation dose above 36.25 Gy provides potential for improved biochemical control of prostate cancer and decrease in relapse free survival.

SUPR-SABR prescription dose to the PTV_4000 will be 8 Gy per fraction for five fractions. The prescription dose to PTV_3625 will be a minimum of 7.25 Gy per fraction for five fractions. SABR will be delivered 2-3 times a week, every other day. There will be a minimum of 40 hours between fractions and maximum of 128 hours between fractions.

SUPR-SABR treatment

Alan Brisendine

Jasmin Brooks

Harriet Eldredge-Hindy, MD

This single arm trial will investigate a novel way to plan and deliver SABR for prostate cancer. Prostate-directed SABR will be high-dose SABR (40 Gy in 5 fractions) with central sparing of the urethra and peripheral sparing of the rectum and pudendal arteries (SUPR-SABR). This study tests the hypothesis that genitourinary (GU) and gastrointestinal (GI) toxicity rates following SUPR-SABR are comparable to (or possibly lower than) historical GU and GI toxicity rates following standard SABR (stSABR) with 36.25 Gy in the treatment of low- and intermediate-risk prostate cancer.

It is estimated that there will be 268,000 prostate cancer diagnoses and nearly 35,000 deaths due to prostate cancer in the United States in 2022 \[1\]. Most men diagnosed with prostate cancer present with localized or organ confined disease which is most commonly managed with active surveillance, prostatectomy, brachytherapy, and external beam radiotherapy (EBRT). Conventionally fractionated (1.8-2.0 Gy per fraction for nine weeks) EBRT is of historical and clinical importance in localized prostate cancer, however, moderately hypofractionated (≥2.5 Gy per fraction for four to six weeks) EBRT and SABR have also emerged as standards of care in appropriately selected patients.

The increased precision associated with image guided stereotactic techniques now permits safe delivery of large doses per fraction, also known as hypofractionation. SABR is a specific type of hypofractionated RT. Hallmarks of the SABR technique, also commonly known as stereotactic body radiotherapy (SBRT), include doses of at least 5 Gy per fraction, five or fewer fractions, motion management, noncoplanar beam or arc therapy, body immobilization, and ablative prescription doses.

There is growing interest in the use of SABR in men with low- and intermediate- risk prostate cancer due to their lower risk of extra prostatic disease including pelvic lymph node micrometastases and the low alpha/beta ratio of prostate cancer. Several series with follow up times exceeding five years have demonstrated excellent biochemical control for SABR approaching 95% for low risk and 80-90% for intermediate risk disease with low rates of clinically significant late GU and GI toxicity. Most published clinical experiences of SABR for prostate cancer have employed 35 to 36.25 Gy in 7- to 7.25 Gy fractions (i.e., standard SABR or stSABR). Importantly, it has never been established whether this represents the optimal dose level for SABR and, nationally, there is not only a single standard of care for SABR prescription dose and fractionation. What is more, contemporary literature with prostate SABR suggests a benefit with dose escalation, however, there is interest in avoiding a parallel increase in GU, GI, and sexual side effects of treatment.

The proposed trial concept would offer men with low- and intermediate-risk prostate cancer a dose-escalated SABR regimen (SUPR-SABR) of 40 Gy in 5 fractions with a safety profile already supported by medical literature and which is expectedly more efficacious than stSABR. This dose and fractionation is already being used in some radiation oncology practices. However, to further improve the therapeutic index of curative RT, the protocol will employ all available methods to spare the urethra, pudendal artery, and rectum (SUPR-SABR): foley catheter placement during planning, rectal spacer gel placement, endorectal balloon during planning and treatment, prostatic immobilization, strict contouring and dose constraints, and the most highly conformal photon planning available. This protocol will offer men a clinical study with highly important endpoints and lower anticipated treatment related morbidity. If the primary analysis demonstrates favorable healthcare related quality of life (HRQOL) with SUPR-SABR when compared to prospectively collected historic controls of stSABR, then this would serve as the basis for a randomized trial between SUPR-SABR and stSABR.

Stereotactic Ablative Radiation Therapy for Prostate Cancer

Phase II Trial of Sparing the Urethra, Pudendal Artery and Rectum During Stereotactic Ablative Body Radiotherapy (SUPR-SABR) for Low and Intermediate Risk Prostate Cancer

EPIC score at 12 months post intervention will be compared with pre-intervention scores. Score scale is 0 to 100 with lower scores indicating more severe symptoms.

EPIC score at 12 months post intervention will be compared with pre-intervention scores. Score is 0 to 100 with lower scores indicating more severe symptoms.

EPIC score at 24 months post intervention will be compared with pre-intervention scores. Score is 0 to 100 with lower scores indicating more severe symptoms.

CTCAE adverse events are on a scale of 0 to 5 with 5 indicating the most severe events.

The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. IPSS scores at 1 month will be compared with baseline pretreatment IPSS scores.

SHIM score is on a scale of 5-25 with lower scores indicating more severe symptoms of erectile dysfunction.

Biochemical failure will be reported as a percentage. biochemical failure is defined as prostate specific antigen nadir post treatment + 2 ng/mL.

SHIM score is 5 to 25 with lower scores indicating worse erectile function

Medical University of South Carolina

Assistant Professor

The low risk cohort will receive:

Stereotactic Ablative Body Radiotherapy as Monotherapy on the CyberKnife System

The high risk cohort will receive:

28 treatments of external beam radiation therapy followed by Stereotactic Ablative Body Radiotherapy as a Boost on the CyberKnife System and hormonal therapy as indicated.

The prescribed planned tumor volume (PTV) dose of 36.25 Gy shall be given in 5 fractions using CyberKnife Hypofractionated Stereotactic Ablative Body Radiation Therapy. PTV will be defined per parameters outlined in the protocol and will at minimum include the entire prostate gland.

Stereotactic Ablative Body Radiotherapy as Monotherapy

The prescribed planned tumor volume (PTV) dose of 27.5 cGy shall be given in 5 fractions using CyberKnife Hypofractionated Stereotactic Ablative Body Radiation Therapy as a boost following 5040 cGy with external beam. PTV will be defined per parameters outlined in the protocol and will at minimum include the entire prostate gland. Hormonal therapy will given as indicated in the protocol.

Stereotactic Ablative Body Radiotherapy as a Boost

Javier Zuniga

Kristina Go-Alejo

Marielou Keuth, CRC

Asif Harsolia, MD

Nisar Syed, MD

Ajmel Puthawala, MD

Linda Chan, MD

Joel Cherlow, MD

Anil Sharma, PhD

Junaid Pasha, MD

The purpose of this study is to determine the side effects and how effective CyberKnife stereotactic ablative body radiation (SABR) is in patients with prostate cancer. The CyberKnife system is a new type of radiation machine that uses a special system to precisely focus large doses of x-rays on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. The purpose of this evaluation is to see if this treatment will help patients with your condition and to evaluate the effect of this treatment on your quality of life over time.

Due to the advances in being able to detect early stage prostate cancer better than before, more men diagnosed with the disease are able to be cured. Methods of prostate cancer treatment include having laparoscopic surgery, having open surgery to remove the prostate, receiving radiation therapy, or brachytherapy (placing high energy x-rays to destroy the cancer cells). Although these treatment options have the potential to cure patients, these treatments have their drawbacks. The healing time following the removal of the prostate can be substantial and local treatments from standard radiation and brachytherapy have potentially negative long term effects. The CyberKnife system is a new type of radiation machine that uses a special system to precisely focus large doses of x-rays on the tumor. The device is designed to concentrate large doses of radiation using robotic image guidance onto the tumor specifically so that injury from radiation to the nearby normal tissue would be minimal. The high doses of radiation directly to the tumor would provide a shorter series of treatments and a faster recovery time. The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with prostate cancer. The purpose of this evaluation is to see if this treatment will help patients with low to intermediate risk prostate cancer and to evaluate the effect of this treatment on the patient's quality of life over time.

Prior to entrance on this study patients will already have had your prostate specific antigen (PSA) checked and a prostate biopsy within the last 12 months. The results of the biopsy showed that the patient has prostate cancer. In addition, patients will have had a digital rectal exam (DRE) to determine if the cancer can be felt. Based on the results of these tests and examination it has been determined that the patient's prostate cancer is in an early stage and has not likely spread outside the prostate or anywhere else in his body. If the patient agrees to be in this study, he will be asked to read and sign this consent form before having any procedure that is required for participation. The patients will be asked to complete some short questionnaires before his CyberKnife treatment. These questionnaires will ask multiple choice questions about the patient's bowel, bladder and sexual function. They will also ask the patient some general questions about his mood, activity and energy levels, and general health. The patient will also have a physical examination and a procedure to place 3 to 5 small gold seeds into the prostate. This procedure is commonly done in patients receiving standard external beam radiation (a type radiation treatment) for prostate cancer and is not an experimental procedure. These gold markers will be used to determine the location of the prostate during the CyberKnife treatment. An ultrasound probe is placed into the rectum and needles containing the gold seeds are guided into the prostate and then the seeds are deposited. The patient will need to clean out his rectum and take antibiotics the day of the seed placement. Within 5-10 days after placement of the gold seeds, the patient will be asked to return to the hospital to have a planning CT scan (a procedure that takes 3-D images) of the pelvis. This is a regular CT scan and is standard procedure for patients receiving external beam irradiation. The images obtained during the scan will be used to plan the CyberKnife treatments. The patient will also have an MRI scan of the pelvis, unless medically contraindicated (for example if he has a pacemaker) which will be used for treatment planning purposes. The patient may be asked to undergo these scans with a urethral catheter in place. The CyberKnife treatment will usually be started after the CT scan of the pelvis. The patient's course of radiation will consist of five separate CyberKnife treatments usually delivered over 5 week days (maximum 14 days), with no less than 12 hours between any two fractions. Each treatment session will take approximately 1.5-2.5 hours. Depending on the risk level of your prostate cancer, the physician may also ask you to have a five week course of external beam radiation therapy prior to the CyberKnife patients and some patients will be asked to go on hormonal therapy. The patient will lie on the treatment table and breathe normally while you receive your radiation treatment. On the last day of treatment a research team member will ask the patient questions about possible side effects. After CyberKnife treatment the patient will need follow-up visits to determine how effective the treatment was and if he is having any treatment related side effects. At 1-2 weeks after treatment is completed, a member of the research team will call you and discuss how you are doing. At 1 month after completion of the CyberKnife treatment, the patient will be asked to return to the hospital for a follow-up examination to check for any side effects. The patient will also be asked to complete the same questionnaires you completed prior to CyberKnife treatment. These questionnaires will ask about hid bowel, bladder and sexual functioning, as well as mood, activity and energy levels, and general health. At 3 and 6 months after completion of the CyberKnife treatment, the patient will be asked to return to your physician for an examination and a blood test to measure your PSA level. This is the standard procedure for follow-up visits and will occur every 6 months thereafter for 5 years. At some of these visits, you also will be asked to complete questionnaires about your bowel, bladder and sexual functioning and your quality of life. If it is suspected that your tumor is growing or if there are concerns about disease progression on the patient's PSA exams, a prostate needle biopsy of the tumor may be performed.

Primary Objective: The primary safety goal of this study is to estimate, in both low-risk and high-risk cohorts, the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity observed following CyberKnife SABR for prostate cancer. The primary efficacy goal is to document the rate of biochemical Disease-Free Survival (bDFS) using the Phoenix and American Society of Therapeutic Radiation and Oncology definitions, at 5 years.

Secondary Objective: To measure the following in the study population: Rates of local failure, distant failure, disease-free survival, disease-specific survival, and overall survival; quality of life (QOL) in generic and organ-specific domains;

Evaluation of CyberKnife Stereotactic Radiotherapy in Prostate Cancer

Prospective Evaluation of CyberKnife Stereotactic Body Radiotherapy for Localized Prostate Cancer: Risk Stratified Monotherapy Versus Boost

The primary safety goal of this study is to estimate, in both low-risk and high-risk cohorts, the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity observed following CyberKnife SABR for prostate cancer. The primary efficacy goal is to document the rate of biochemical Disease-Free Survival (bDFS) using the Phoenix and American Society of Therapeutic Radiation and Oncology definitions, at 5 years.

To measure the following in the study population: Rates of local failure, distant failure, disease-free survival, disease-specific survival, and overall survival; quality of life (QOL) in generic and organ-specific domains;

MemorialCare Health System

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Radiotherapy: 48Gy delivered in 4 fractions, delivered over 2 weeks, with each fraction delivered 48 hours apart.

Radiotherapy: 28Gy delivered in 1 fraction

Multi-fraction SABR; 48Gy delivered in 4 fractions, delivered over 2 weeks, with each fraction delivered 48 hours apart.

Multi-fraction SABR

Single fraction SABR; 28Gy delivered in 1 fraction

Single Fraction SABR

Shankar Siva

The main purpose of this study is to determine the safety (defined as number of participants experiencing ≥ 5% toxicity at 12 months post treatment) of stereotactic ablative fractionated radiotherapy versus radiosurgery for oligometastatic neoplasia to the lung.

Stereotactic Ablative Body Radiotherapy (SABR) is an exciting novel radiotherapy technique that is delivered over very few sessions. In the case of limited pulmonary 'oligometastases', SABR can result in long-term survival. It is non-invasive and associated with high rates of tumour control and relatively low toxicity. Additionally, the large doses of precision radiotherapy involved may evoke a strong immune response to recognise and attack any remaining tumour cells. In the future, SABR may be an attractive alternative to invasive surgery. There are two SABR techniques emerging in Australia; fractionated and single fraction treatments. We aim to conduct the first clinical trial of SABR in patients with limited pulmonary metastases testing fractionated versus single fraction treatments.

The primary aim of this study is to evaluate the toxicity, Quality of Life, clinical efficacy and cost effectiveness of single fraction SABR compared to multi-fraction SABR in patients with oligometastases to the lung.

The secondary aim of this study is to assess the immune response evoked by both fractionated and single fraction SABR and its prognostic implications for patient outcomes.

A Randomized Phase II Study of Stereotactic Ablative Body Radiotherapy for Metastases to the Lung (TROG 13.01 SAFRON II)

Stereotactic Ablative Fractionated Radiotherapy Versus Radiosurgery for Oligometastatic Neoplasia to the Lung: A Randomised Phase II Trial

To explore immune system responses to single fraction and multi-fraction SABR.

The primary outcome is safety, defined as number of participants experiencing less than or equal to 5% toxicity at 12 months post treatment (toxicity as measured by CTCAE V4).

To compare quality of life outcomes between techniques assessed using EQ-5DL and MDASI-LC questionnaires.

Local progression free survival assesed by CT scan and clinical assessment

Overall survival assesed by clinical assessment

Time to distant failure assessed by CT scan and clinical assessment

Resources use and costs associated with treatment assessed by EQ5DL and accessing Medicare data

Disease free survival will be measured from the date of randomisation to the date of a local recurrence, regional or distant metastasis, or death from any cause, whichever occurs first.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Proton-Based Stereotactic Ablative Body Radiotherapy for Prostate Cancer	NCT03159676	Prostate Cancer	Proton beam	18 Years -	Mayo Clinic
Stereotactic Ablative Body Radiotherapy (SABR) for Oligometastases	NCT02933242	Metastatic Tumo...	Stereotactic Ab...	18 Years -	British Columbia Cancer Agency
Stereotactic Ablative Radiation Therapy for Prostate Cancer	NCT05668351	Prostate Cancer	SUPR-SABR treat...	18 Years -	Medical University of South Carolina
Evaluation of CyberKnife Stereotactic Radiotherapy in Prostate Cancer	NCT02016248	Prostate Cancer	Stereotactic Ab... Stereotactic Ab...	18 Years -	MemorialCare Health System
Stereotactic Ablative Body Radiotherapy (SABR) for Oligometastases	NCT02933242	Metastatic Tumo...	Stereotactic Ab...	18 Years -	British Columbia Cancer Agency
A Randomized Phase II Study of Stereotactic Ablative Body Radiotherapy for Metastases to the Lung (TROG 13.01 SAFRON II)	NCT01965223	Cancer Metastases to t...	Multi-fraction ... Single Fraction...	18 Years -	Trans Tasman Radiation Oncology Group

Spots Global Cancer Trial Database for stereotactic ablative body radiotherapy