Stereotactic Ablative Radiotherapy (SABR) for Low Risk Prostate Cancer With Injectable Rectal Spacer

NCT02353832 | Completed Phase 2 Results DMC

• 1 other identifier: STU 092013-013
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose is to determine if use of rectal spacers are effective at improving protection of rectum from high dose radiation, using rate of rectal ulceration as a surrogate measure of acute effects. It is also to determine whether it provides sufficient dosimetric benefits to warrant further clinical investigation in future SABR (Stereotactic Ablative Body Radiation) related clinical studies.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Reduction in Acute Per-prostatic Rectal Ulcer Events Events From 90%+ to <70% (Particularly in the Anterior Rectum)

  The effectiveness of rectal spacer use was measured to determine if they are effective at improving protection of rectum from high dose radiation, using rate of rectal ulceration as a surrogate measure of acute effects

  Median 9 months within the end of radiation treatment

• Effectiveness of Space Creation of >= 7.5 mm in Protecting Rectum From Toxicity

  The effectiveness of rectal spacer use was measured to determine if they are effective at improving protection of rectum from high dose radiation, using rate of rectal ulceration as a surrogate measure of acute effects

  Median 9 months within the end of radiation treatment

Secondary Outcomes (30)

• Percentage of Participants With Spacer Related Acute Toxicity

  270 days

• Determine Spacer's Ability to Change Percent Rectal Circumference (PRC) Receiving 39 Gy

  1 month

• Determine Spacer's Ability to Change Percent Rectal Circumference (PRC) Receiving 24 Gy.

  1 month

• Acute (Within 270 Days of Treatment) SABR-related Gastrointestinal (GI) Toxicities

  270 days

• Acute (Within 270 Days of Treatment) SABR-related Genitourinary (GU) Toxicities

  270 days

Study Arms (1)

No Arm

OTHER

Study did not have Arm(s)

Device: Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent)

Interventions

Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent) DEVICE

Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product

No Arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Male only study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must be willing and capable to provide informed consent to participate in the protocol.
• Eligible patients must have appropriate staging studies identifying them as AJCC stage T1 (a, b, or c) or T2a or T2b adenocarcinoma of the prostate gland. The patient should not have direct evidence of regional or distant metastases after appropriate staging studies. Histologic confirmation of cancer will be required by biopsy performed within 180 days of registration.
• The patient's Zubrod performance status must be 0-2.
• The Gleason score should be less than or equal to 6 or 3+4 if \< 50% of a 12 core biopsy was involved.
• The serum PSA should be less than or equal to 10 ng/ml.
• Study entry PSA must not be obtained during the following time frames: 10 day period following prostate biopsy; following initiation of ADT; within 30 days after discontinuation of finasteride; or within 90 days after discontinuation of dutasteride.
• Age ≥ 18 years.
• Patients may have used prior hormonal therapy, but it should be limited to no more than 9 months of therapy prior to enrollment.
• The ultrasound, or CT based volume estimation of the patient's prostate gland should be ≤ 60 grams.

You may not qualify if:

• Subjects who have had previous pelvic radiotherapy or have had chemotherapy or surgery for prostate cancer.
• Subjects who have plans to receive other concomitant or post treatment adjuvant antineoplastic therapy while on this protocol including surgery, cryotherapy, conventionally fractionated radiotherapy, hormonal therapy, or chemotherapy given as part of the treatment of prostate cancer.
• Subjects who have undergone previous transurethral resection of the prostate (TURP) or cryotherapy to the prostate. Subjects who have significant urinary obstructive symptoms; AUA score must be ≤15 (alpha blockers allowed).
• Subjects who have a history of significant psychiatric illness.
• Men of reproductive potential who do not agree that they or their partner will use an effective contraceptive method such as condom/diaphragm and spermacidal foam, intrauterine device (IUD), or prescription birth control pills.
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
• Severe, active co-morbidity, defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months.
• Transmural myocardial infarction within the last 6 months.
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
• Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration.
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
• Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
• Patients with history of inflammatory colitis (including Crohn's Disease and Ulcerative colitis) are not eligible.
• Subjects with a known allergy to polyethylene glycol hydrogel (spacer material) or contraindication to spacer products (Duraseal or SpaceOAR).

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Michael Folkert, M.D., Ph.D.
• Organization: University of Texas Southwestern

Michael.Folkert@utsouthwestern.edu

214-645-8525

Study Officials

• Michael Folkert, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

• Michael Zelefsky, MD

  Memorial Sloan Kettering Cancer Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: February 3, 2015
• Study Start: November 6, 2014
• Primary Completion: January 29, 2018
• Study Completion: January 5, 2021
• Last Updated: March 25, 2022
• Results First Posted: May 7, 2019

Record last verified: 2022-03

Locations

US (2)