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Brachytherapy implant procedure lasting 1-2 hours. Questionnaires taking 30 total minutes.

Brachytherapy implant procedure lasting 1-2 hours.

Brachytherapy

Questionnaire

Steven J. Frank, MD

The goal of this clinical research study is to learn if a prostate implant (brachytherapy) can help to control intermediate risk prostate cancer. The safety of this procedure will also be studied.

Prostate brachytherapy is performed by inserting permanent seeds (which are radioactive pellets) into your prostate in order to treat the prostate cancer with radiation therapy.

If you are found to be eligible to take part in this study, you will have an ultrasound of your prostate before brachytherapy so that the prostate can be measured and mapped and the placement of the needles and seeds planned ahead of time. This is a 20-minute outpatient procedure that involves placing a probe (tube) into your rectum, which takes ultrasound pictures of the prostate to learn the size and shape. A specialized radiation plan for each patient is made, and the exact number of needles and seeds depend on the size and shape of the prostate. Ultrasound pictures, using the probe in the rectum, are taken before the implant procedure so that the plan can be made.

Brachytherapy is an outpatient surgical procedure. Under general or spinal anesthesia, you will have thin needles inserted through the skin between the anus and the scrotum. Seeds are inserted into the prostate through the needles. An ultrasound probe (tube which sends images of the prostate to a screen) is placed into the rectum and remains there during the procedure to help direct the needles. After the seeds are inserted, the needles are removed. The seeds remain permanently in the prostate. Typically, about 25 needles are inserted with about 100 seeds. The implant procedure takes about 1-2 hours in the operating room. Afterwards, you will go to the recovery room for 1-3 hours. You will then have a computed tomography (CT) scan after the procedure to make sure the seeds are properly placed. You will then be allowed to return home.

After treatment, you will have a study visit in 4-6 weeks. After that first follow-up visit, you will have follow-up visits at 4, 8, and 12 months (+/- 3 weeks) after treatment. After that, follow-up visits are every 6 months until 5 years after treatment and then once a year from then on (+/- 3 weeks). At these visits, you will have a physical exam. This may include a digital rectal exam if your doctor feels that it is needed. Blood (about 3 teaspoons) will be drawn for routine tests. You will be asked to complete 2 questionnaires about your urinary, bowel, sexual function, and overall quality of life. The 2 questionnaires take about 30 minutes to complete in total. A CT scan of the prostate will also be performed at the first follow-up visit after the implant to make sure the seeds are properly placed.

If blood tests show that your cancer is getting worse, a biopsy may be done after the treatment is complete. A biopsy is done by inserting a needle through the rectum and into the prostate. The procedure is similar to the one done to first diagnose your prostate cancer. Six (6) to 10 samples are usually taken. The doctor will also perform an ultrasound. This is done by placing a tube in the rectum, which shows a picture of the prostate on a screen and is used to guide the biopsies.

You will be taken off study if your disease progresses. Otherwise, you will remain on study indefinitely.

This is an investigational study. Brachytherapy is FDA approved. Up to 300 patients will take part in this study. All will be enrolled at MD Anderson.

Brachytherapy for Prostatic Carcinoma Patients

Transperineal Interstitial Permanent Brachytherapy Alone for Selected Patients With Intermediate Risk Prostatic Carcinoma

M.D. Anderson Cancer Center

Radical prostatectomy with extended pelvic lymph node dissection

ePLND is performed either before or after radical prostatectomy and includes the removal of all nodal and fibro-fatty tissue

Radical prostatectomy (RP) followed by ePLND

Radical prostatectomy (RP) only

Cyrill A. Rentsch, MD-PhD

For patients with intermediate-risk prostate cancer plus a predicted risk of \>5% for positive lymph nodes and with high-risk prostate cancer, international guidelines recommend ePLND along with the RP. Besides an improved accuracy in staging, the therapeutic role of ePLND remains controversial. We hypothesize that ePLND prolongs time to biochemical recurrence (BCR) and prostate cancer-specific survival (PCSS) in intermediate- and high-risk PCa patients.

Radical prostatectomy (RP) is the surgical standard treatment for men with localized prostate cancer (PCa) and a life expectancy of \> 10 years. RP is a treatment option for localized PCa that shows benefit in prostate cancer-specific survival (PCSS) and overall survival compared to conservative management. According to the guideline recommendations of the European Association of Urology (EAU), RP should be accompanied by extended pelvic lymph node dissection (ePLND) in patients with intermediate-risk PCa (D'Amico classification) and \> 5% nomogram (Briganti) predicted risk of positive lymph nodes and in all high-risk PCa cases.

Besides an improved accuracy in staging, the therapeutic role of ePLND remains controversial. The primary goal of this trial is to provide high-level evidence regarding the therapeutic benefit of ePLND in intermediate- and high-risk PCa patients without clinical evidence of nodal involvement. It is hypothesized that ePLND prolongs time to biochemical recurrence (BCR) and prostate cancer-specific survival (PCSS) in intermediate- and high-risk PCa patients.

SAKK 09/18 is an international, multicenter, randomized, phase III surgical intervention trial

Extended Pelvic Lymph Node Dissection vs. no Pelvic Lymph Node Dissection at Radical Prostatectomy for intermediate-and High-risk Prostate Cancer

Extended Pelvic Lymph Node Dissection vs. no Pelvic Lymph Node Dissection at Radical Prostatectomy for intermediate-and High-risk Prostate Cancer: An International, Multicenter, Randomized Phase III Trial

The primary endpoint of this trial is time to BCR, defined as time from randomization to biochemical recurrence, defined as serum PSA level ≥ 0.2 ng/ml, with a second confirmatory serum PSA level ≥ 0.2 ng/ml. Patients not experiencing an event will be censored at the date of the last available assessment or at the start of adjuvant or salvage treatment, if any.

PSA persistence is defined as failure to reach a PSA value of \<0.1 ng/ml within 12 weeks (+ 2 weeks) postoperatively.

Patients with no assessments within the first 12 weeks (+ 2 weeks) after surgery will be counted as failures for this endpoint

Time to initiation of adjuvant or salvage therapies will be calculated as the time from randomization to the start of any type of adjuvant or salvage therapy. Patients not starting adjuvant or salvage therapies are censored at the last date they were known to be alive.

Time to loco-regional recurrence will be calculated from randomization until local (prostate bed) or regional (extent of ePLND template) recurrence, whichever occurs first. Patients not experiencing an event will be censored at the date of the last available assessment or at the start of adjuvant or salvage therapy, if any.

Time to distant metastasis will be calculated from randomization until first occurrence of distant metastasis. Patients not experiencing an event will be censored at the date of the last available assessment.

PCSS will be calculated as the time from randomization to the date of death due to prostate cancer. Patients who died due to other reasons will be censored at the time of death. All other patients will be censored at the last date they were known to be alive.

Causes of death may require critical review by the coordinating investigator and the medical advisor. Particular attention will be paid to men who have been reported as having died from prostate cancer without previously reported progression or recurrence and men who were reported as having died from non-prostate cancer causes after developing biochemical or clinical progression.

OS will be calculated from randomization until death from any cause. Patients not experiencing an event will be censored at the last date they were known to be alive.

Intraoperative complications will be assessed using the CLASSIC system.

Postoperative complications will be assessed using the Clavien-Dindo classification.

AEs will be assessed according to NCI CTCAE v5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Brachytherapy for Prostatic Carcinoma Patients	NCT00525720	Prostate Cancer	Brachytherapy Questionnaire	18 Years -	M.D. Anderson Cancer Center
Extended Pelvic Lymph Node Dissection vs. no Pelvic Lymph Node Dissection at Radical Prostatectomy for intermediate-and High-risk Prostate Cancer	NCT03921996	Prostate Cancer	Radical prostat... Radical prostat...	18 Years - 80 Years	Swiss Group for Clinical Cancer Research
Brachytherapy for Prostatic Carcinoma Patients	NCT00525720	Prostate Cancer	Brachytherapy Questionnaire	18 Years -	M.D. Anderson Cancer Center
Extended Pelvic Lymph Node Dissection vs. no Pelvic Lymph Node Dissection at Radical Prostatectomy for intermediate-and High-risk Prostate Cancer	NCT03921996	Prostate Cancer	Radical prostat... Radical prostat...	18 Years - 80 Years	Swiss Group for Clinical Cancer Research

Spots Global Cancer Trial Database for intermediate prostate cancer