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

Group 1 : Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion.

Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.

Group 2 : Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months.

Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.

Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion.

Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.

Endorectal Balloon

Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months.

Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.

Rectal Spacer

Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.

Radiation therapy

Josephine Kang, M.D.

Silvia Formenti, M.D.

Patients with low-risk or favorable intermediate-risk prostate cancer as defined by 1.2016 NCCN criteria will be eligible to participate on this study.

This is a randomized, two arm study for patients with low-risk or favorable intermediate-risk prostate cancer as defined by 1.2016 NCCN criteria.

Patients will be randomized to either rectal spacer placement or endorectal balloon placement, daily prior to each radiation treatment.

1. Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion.
2. Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months.

This study plans to enroll a total of 40 patients with an accrual period of 4 years.

Randomized Trial of Image -Guided Stereotactic Radiation Therapy (IG-SRT) in Prostate Cancer

To explore microbiome changes associated with normal tissue toxicities resulting from radiation

Comparing NLR ratio at different timepoints to assess the impact of radiation therapy on patients. A neutrophil:lymphocyte ratio (NLR) \> 4 at time radiotherapy predicts for significantly worse prognosis, when compared to NLR \< 4.

To compare acute toxicity (as defined by CTCAE v4.0) and to compare Rectal dose (V35, max rectal dose). Acute radiation toxicities are side effects that occur on treatment or in the immediate post treatment period (within 90 days from the start of radiation treatment).

To compare health-related quality of life (HRQOL) measured using the Expanded Prostate Cancer Index Composite (EPIC) instrument for bowel, urinary and sexual domains. scores are transformed linearly to a 0-100 scale (see following page: EPIC scoring), with higher scores representing better HRQOL. American Urological Association (AUA) scores ranges from 0-30 scores where, score greater than 15 indicate high degree of urinary symptoms and scores less than 15 indicate low degree of urinary symptoms.

To compare the dose distribution of the 2 techniques, specifically:

1. coverage of the PTV
2. DVH of organs at risk (OAR)
3. prostate motion and shifts required during treatment

To compare late toxicity (as defined by CTCAE v4.0). Late toxicities are toxicities that occur greater than 3 months after radiation therapy completion.

Weill Medical College of Cornell University

The adverse events were collected based on the CTCAEv4.03. 0 subjects at risk in the rectal spacer - radiation therapy arm because the trial was closed due to lack of accrual.

Group 1 : Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion.Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.

Endorectal Balloon: Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion.

Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.

Endorectal Balloon - Radiation Therapy

Group 2 : Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months.

Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.

Rectal Spacer: Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months.

Rectal Spacer - Radiation Therapy

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

EPIC GU

EPIC GI

EPIC Sexual health

AUA scores

Measure the effect of treatment on patients using Health related Quality of Life based on Expanded Prostate Cancer Index Composite Question. For EPIC GU, EPIC GI and Sexual Health higher (range 0-100) scores represent Good quality of life. For AUA scores ( range 0-35), Lower scores represent less urinary symptoms.

Health Related Quality of Life Based on Expanded Prostate Cancer Index Composite Question

Comparing Neutrophil:Lymphocyte ratio

The study accrued only one patient . 0(zero) subjects were analyzed in the rectal spacer arm due to lack of accrual.

Josephine Kang, M.D. Ph.D.

Data was not collected for the Rectal Spacer - Radiation Therapy arm because the trial was terminated due to lack of accrual.

Incidence of Patient-reported Acute Toxicity Based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4

EPIC GU (post treatment)

EPIC GI (post treatment)

Group 1 : Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion.Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.

Endorectal Balloon: Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion.Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.

Group 2 : Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months.

Rectal Spacer: Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months.

Measure the Effect of Treatment on Patients' Using Health Related Quality of Life Based on Expanded Prostate Cancer Index Composite Questionnaire

Baseline visit

1 month post Radiation visit

6 month post Radiation visit

1 year post Radiation visit

Number of Participants With Recurrence-free Survival

Data could not be analyzed for the secondary outcome measure as we needed more than one patient to compare two radiation techniques. The trial was terminated due to lack of accrual.

Comparing Several Parameters That Are Involved in Treatment Planning in Patients Randomized to Two Radiation Therapy Modalities.

Incidence of Patient-reported Toxicity (Late Toxicity) Based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4

Data was not collected for both Endorectal balloon arm and the Rectal Spacer - Radiation Therapy arm.

Measuring Number of Participants Changes in the Microbiome That is Associated With Normal Tissue Toxicities Resulting From Radiation From Baseline to End of Treatment

Spots Global Cancer Trial Database for Randomized Trial of Image -Guided Stereotactic Radiation Therapy (IG-SRT) in Prostate Cancer

Trial Identification

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Study Description

Keywords

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