CLINICAL TRIAL

51.6 Gy IMRT for Prostate Cancer

Metastatic
Waitlist Available · 18+ · Male · Denver, CO

This study is evaluating whether a new type of radiation therapy is better than standard radiation therapy for treating prostate cancer.

See full description

About the trial for Prostate Cancer

Eligible Conditions
Prostate Cancer · Psychosocial Effects of Cancer and Its Treatment · Radiation Toxicity · Prostatic Neoplasms · Sexual Dysfunctions

Treatment Groups

This trial involves 2 different treatments. 51.6 Gy IMRT is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
36.25 Gy IMRT
RADIATION
Experimental Group 2
51.6 Gy IMRT
RADIATION

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:
were considered low risk The evaluation of the prostate biopsy tissue sample was done histologically and a Gleason score was assigned to the sample show original
The patient has stage 1 or 2 cancer, within 90 days of being randomized into the study. show original
were predictors of quality of life in men with prostate cancer show original
It is advised that a PSA blood test should not be carried out within 10 days after a prostate biopsy. show original
The patient has no evidence of distant metastases. show original
The individual had a physical examination and a digital rectal examination of the prostate within 60 days prior to registration. show original
The patient has been diagnosed with adenocarcinoma of the prostate within 180 days of being randomized to the study. show original
No prior history of prostate cancer The subject has a PSA level of 10 ng/mL or less within 60 days prior to registration and has no prior history of prostate cancer. show original
No regional lymph node involvement
Zubrod Performance Status is a measure of the patient's overall health show original
View All
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
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline and one year from the end of protocol treatment
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline and one year from the end of protocol treatment
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline and one year from the end of protocol treatment.
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 51.6 Gy IMRT will improve 2 primary outcomes and 10 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of Baseline and one year from the end of protocol treatment.

The Percentage of Patients With Reduction From Baseline at One Year in EPIC Hormonal Domain Score That Exceeds 3 Points
BASELINE AND ONE YEAR FROM THE END OF PROTOCOL TREATMENT
The percentage of patients with a reduction in the EPIC hormonal domain score from baseline that exceeds 3 points (baseline - one year > 3). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other.
BASELINE AND ONE YEAR FROM THE END OF PROTOCOL TREATMENT
Rate of PSA Failure
REGISTRATION TO FIVE YEARS
Failure occurs when the PSA is first noted to be 2 ng/mL or more than the current nadir value (PSA > current nadir + 2) post RT completion. Time to PSA failure is defined as time from registration to the date of PSA failure, last known follow-up (censored), or death without PSA failure (competing risk). Rate of PSA failure is estimated by the cumulative incidence method. The protocol specified that one-, two-, and five-year rates would be reported. Arms are not compared to each other.
REGISTRATION TO FIVE YEARS
Mean Quality Adjusted Life Years at 5 Years
REGISTRATION TO 5 YEARS FROM THE END OF PROTOCOL TREATMENT
Quality-adjusted survival time combines disease-free survival time and quality of life as measured by the EuroQol 5-dimensional (EQ-5D) index score. It is calculated for each patient as the weighted sum of different time episodes and added up to total quality-adjusted life years . The EQ-5D measures health-related quality of life and consists of two parts, a general health visual analog scale and 5 general health questions. The latter questions are transformed into a single index score ranging from 0 (worst health state) to 1 (best health state). Arms are not compared to each other.
REGISTRATION TO 5 YEARS FROM THE END OF PROTOCOL TREATMENT
Rate of Disease-free Survival (DFS)
REGISTRATION TO 5 YEARS
Disease-free survival duration is time from the date of randomization to the date of documentation of disease progression or until the date of death from any cause (censored). DFS is estimated by the Kaplan-Meier method. The protocol specified that one-, two-, and five-year rates would be reported. Arms are not compared to each other.
REGISTRATION TO 5 YEARS
Change From Baseline in EQ-5D Scores
BASELINE AND ONE YEAR FROM THE END OF PROTOCOL TREATMENT
The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). Change from baseline is calculated as score at the timepoint of interested - baseline score. One, 2, and 5 years will be entered when they are available. Arms are not compared.
BASELINE AND ONE YEAR FROM THE END OF PROTOCOL TREATMENT
Acute and Late Gastrointestinal (GI) and Genitourinary (GU) Toxicity for Each Arm
START OF PROTOCOL TREATMENT TO ONE YEAR FROM THE END OF PROTOCOL TREATMENT
Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. An acute adverse event is defined as the first occurrence of worst severity of the adverse event ≤30 days after the completion of radiation therapy (RT). The high dose RT arm of Radiation Therapy Oncology Group (RTOG) study RTOG-0126 (NCT00033631) reported 1% of patients experienced grade 3+ GI/GU acute toxicity with no patient experiencing a grade 4 or 5 toxicity. If the lower confidence interval is >1%, then that arm will be further investigated for acceptability. A late adverse event is defined as the first occurrence of worst severity of adverse event >30 days after RT completion. Arms are not compared to each other.
START OF PROTOCOL TREATMENT TO ONE YEAR FROM THE END OF PROTOCOL TREATMENT
See More

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 is prostate cancer?

To avoid unnecessary and incorrect treatment, men with PC should receive a PSA test and Gleason score prior to initiating treatment. As more research is conducted, more information on the natural history of this disease can become available.

Anonymous Patient Answer

What causes prostate cancer?

The causes of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) can be complex, and it is thought that the cancer arises from multistep processes involving cell growth and differentiation. Prostate cancer can also be caused by a number of environmental factors, including toxins and infections. However, further research is needed to understand how these causes of prostate cancer act.

Anonymous Patient Answer

Can prostate cancer be cured?

More emphasis should be placed on quality of life effects, disease-free survival, and other factors other than cancer stage on the quality of life in men with castration-resistant prostate cancer.

Anonymous Patient Answer

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

There were around 2.6 million newly diagnosed cases of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) in 2013 (around 9% of those diagnosed with any type of cancer). This made up 21% of all men diagnosed with a cancer in 2013. And there are an estimated 18,800 deaths due to prostate cancer per year.\n\n- Cancer in the United States"

"Rhypsiada\n\nRhypsiada is a genus of moths of the family Crambidae described by Carl Friedrich Roewer in 1961.

Anonymous Patient Answer

What are the signs of prostate cancer?

The signs of prostate cancer are vague and often non-specific. They include general symptoms, such as increased urgency, reduced urination, nocturia and incontinence. These signs may have been caused by prostate cancer rather than benign prostatic abnormalities.

Anonymous Patient Answer

What are common treatments for prostate cancer?

This survey confirms some of the conclusions in the literature that psychological therapy and the stress-reduction therapy of group and individual psychotherapy are useful in decreasing anxiety produced by the diagnosis of an occult malignancy, and that the use of medication for the treatment of the symptoms of distress is also important. For cancer patients specifically, the use of medical treatment should be individualized and discussed with the patient before the initiation of therapy.

Anonymous Patient Answer

Is 51.6 gy imrt safe for people?

The current study confirms both the safety and effectiveness of the three doso tions used, in terms of LDR and PSA response, irrespective of irradiation modality used.

Anonymous Patient Answer

Has 51.6 gy imrt proven to be more effective than a placebo?

In case of advanced bladder carcinoma in palliative setting, the new generation 3D-CRT has higher palliative and pain relief compared with previous 3D-CRT. In case of early bladder carcinoma, the 51.6Gy IMRT is more effective than the 36Gy CRT as well as the 9Gy CRT.

Anonymous Patient Answer

Have there been any new discoveries for treating prostate cancer?

In recent years, new approaches have been made to treat and even prevent prostate cancer. The possibilities that exist now for using laser radiation for the treatment of prostate cancer and for creating immunosuppressive drugs that may lead to better patient survival is a most exciting hope to many physicians.

Anonymous Patient Answer

What are the latest developments in 51.6 gy imrt for therapeutic use?

These data suggest a new and safer application of IMRT to the prostate and the pelvic lymph nodes, leading to a more homogeneous dose coverage with better plans. They also suggest that the therapeutic doses could be reduced by 15-25% without compromising the treatment efficacy in our patients.

Anonymous Patient Answer

What does 51.6 gy imrt usually treat?

The authors reviewed a diverse group of 486 patients treated by IMRT at St. Luke's Medical Center in New York over an 11-year period, and found no association, either positive or negative, between clinical factors and toxicity or dose to OARs in this cohort. As demonstrated by our data, the use of IMRT does not result in an increase in toxicity relative to conventional techniques of radiation therapy, and the dosages given at the 50% and 92% isodoses may exceed that prescribed by conventional techniques.

Anonymous Patient Answer

What are the common side effects of 51.6 gy imrt?

The common side effects of fractionating irradiation to the prostate are: irritation and mild pain at the treatment site, asymptomatic bleeding or rectal bleeding or rectal irritation. Symptoms of urethral toxicity included urgency and pain, and irritation and bleeding at the treatment site, and were usually more pronounced in the third, fourth, and fifth years after the treatment. The urethral toxicity induced by irradiation depends on the time after irradiation, dose delivered to the urethra, and treatment site of the radiation fields.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Prostate Cancer by sharing your contact details with the study coordinator.