CLINICAL TRIAL

Stereotactic Ablative Radiotherapy for Prostate Cancer

Waitlist Available · 18+ · Male · Dallas, TX

This study is evaluating whether radiation can be safely escalated to the pelvic lymph nodes.

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About the trial for Prostate Cancer

Eligible Conditions
Prostate Cancer · Prostatic Neoplasms

Treatment Groups

This trial involves 2 different treatments. Stereotactic Ablative Radiotherapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Stereotactic Ablative Radiotherapy
RADIATION
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for male patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
) The patient must have appropriate staging studies to identify them as having adenocarcinoma of the prostate gland that is stage T3+ show original
Male patient who is over 18 years old at the time of registration. show original
The patient must have a Zubrod performance status of 0-2. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 5 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Stereotactic Ablative Radiotherapy will improve 1 primary outcome and 5 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of 90 days.

maximum tolerated dose (MTD)
90 DAYS
Determine the maximum tolerated dose (MTD) or to safely escalate dose to the pelvic nodal PTV using 90 day acute toxicity endpoint
Adverse events
90 DAYS
Determine the safety of 9.5 Gy per fraction in five fractions (47.5 Gy total dose) to the prostate/SV PTV
Overall survival
5 YEARS
To follow tumor related outcomes , overall survival (OS)
Health-related quality of life
5 YEARS
Health-related quality of life (HRQOL) will be measured as part of current clinical practice
Progression-free survival
5 YEARS
To follow tumor related outcomes (progression-free survival (PFS), distant metastasis (DM) free survival)
PSA
5 YEARS
To follow tumor response to treatment

Who is running the study

Principal Investigator
R. H.
Raquibul Hannan, MD
University of Texas Southwestern Medical Center

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for prostate cancer?

There is no cure for [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer), so treatments are aimed at symptom control, surveillance, and prevention of the disease getting worse. A multidisciplinary treatment plan for cancer treatment planning should be established for all patients, particularly for patients with newly diagnosed prostate cancer.

Anonymous Patient Answer

What are the signs of prostate cancer?

Signs of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) include pain, urgency, increased frequency of urination, and a lump or lump in the back. Because prostate cancer can mimic and be confused with benign conditions such as BPH, the first symptom of prostate cancer may be a difficulty urinating. It is important to distinguish the symptoms of benign prostatic hyperplasia (BPH) from those of cancer. BPH may cause a feeling of urgency, frequency of urination, or both. If a patient does feel he or she has a lump in the back, then they should see a doctor to determine if it might be prostate cancer. Finally, if there is any doubt about whether it is prostate cancer, then getting a biopsy is the best way to be sure.

Anonymous Patient Answer

What is prostate cancer?

With the onset of prostate cancer, men have changes in lifestyle and medical concerns. These changes may be related to a reduction in sexual desire and an increase in erectile dysfunction. However, the prostate cancer diagnosis itself should not be expected to have a negative impact on erectile function. The diagnosis of prostate cancer has been associated with decreased sexual desire in men. However, this difference in sexual dysfunction is not as great as in men who were diagnosed with prostate cancer in earlier life. Prostate cancer is also associated with reduced sexual satisfaction in men; however, this decrease is modest, which may be attributable to sexual satisfaction following prostate cancer treatment. Future studies that take into account the impact of prostate cancer diagnosis on sexual function are needed.

Anonymous Patient Answer

How many people get prostate cancer a year in the United States?

More than 6 percent of men in the United States have prostate cancer of the aggressive type at some time. There are regional differences in the age-adjusted trends.

Anonymous Patient Answer

What causes prostate cancer?

Prostate cancer does not have a specific cause. Some authors propose a 'two-hit' theory of causation, where an early risk factor causes prostate cancer, and subsequent exposure to a risk factor makes the cells more cancerous, and may contribute to disease aggressiveness. However, this theory may work in combination with other factors. It is likely both genetic and environmental factors work in combination to produce prostate cancer.

Anonymous Patient Answer

Can prostate cancer be cured?

Prostate cancer is not curable, but with good treatment, symptoms can be effectively controlled. Prostate cancer can be managed by good screening, regular examination and biopsy, and in men with low-risk disease, a watchful waiting strategy can be employed. A prospective cure trial would be impossible to define precisely what constitutes a cure.

Anonymous Patient Answer

How serious can prostate cancer be?

Radical treatment of localized prostate cancer has an acceptable mortality rate. This mortality is related to the extent of the disease as well as to the age and health status of the individual.

Anonymous Patient Answer

What are the chances of developing prostate cancer?

A lifetime risk calculation that can be done based on the age of first ejaculation, total number of sexual partners, percentage of lifetime sexual partners with a partner, number of sex partners in a year, and race and age at onset of first sexual activity. This procedure can be used in research studies and the prediction of the chance of developing prostate cancer.

Anonymous Patient Answer

What is the survival rate for prostate cancer?

In this cohort from Denmark, the risk for death in [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) could be estimated as 1.0/(1.-(PIR)/4). PIR was calculated according to age, smoking status and stage of disease on the basis of a prospective cohort study from Finland in 1996, which was published in 2001. In the Danish study PIR was measured from the register of deaths from cancer in 1992. The Danish study provides a good estimate for mortality from prostate cancer and confirms the results of the cohort study from Finland.

Anonymous Patient Answer

What is stereotactic ablative radiotherapy?

Our case series adds a significant dimension to the current literature on the efficacy and the safety of SAA brachytherapy in the treatment of BPH. The long-term safety of this modality needs careful assessment but our series demonstrates a trend toward improvement of quality of life, urinary symptoms and the need for subsequent invasive surgery, in patients treated in the early stages of this disease.

Anonymous Patient Answer

What are the latest developments in stereotactic ablative radiotherapy for therapeutic use?

• Stereotactic ablative radiotherapy (SIRA) is a new non-invasive form of radiation treatment. • High-dose RT may also be effective in the treatment of advanced cancers in patients who cannot or will not benefit from surgery. • Radiation oncologists may use high-dose RT to treat localised tumours, or metastatic disease in organs which cannot be spared from radiotherapy. • SIRA has already been used locally as a salvage treatment for a series of late-stage head and neck or lung cancer patients who have relapse after surgery. • SIRA has been used to treat a range of tumour sites. • Early use of SIRA for early-stage prostate cancer has been successful.

Anonymous Patient Answer

What does stereotactic ablative radiotherapy usually treat?

The common treatment strategies to treat [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) consist of intensity modulated radiotherapy combined with other modalities like androgen deprivation therapy or androgen deprivation chemo-radiation, high dose external beam radiation therapy, radiotherapy after prostatectomy and stereotactic ablative radiotherapy. Stereotactic ablative radiotherapy was only indicated for non and/or partially resected prostate carcinoma, for a complete responders, for locally advanced unresectable prostate carcinoma.

Anonymous Patient Answer
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