Ultra-hypofractionated Radiation in Prostate Cancer

NCT ID: NCT03486821

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-22
• Study Completion Date: 2026-03-01

Brief Summary

The primary objective of this study is to demonstrate that ultra-hypofractionation of prostate cancer does not increase urinary toxicity as defined by the EPIC-26 GU domain patient reported outcome.

Detailed Description

This is a pilot clinical trial looking at 2 fraction SBRT radiation therapy as an alternative to standard of care. Data does not yet exist for the safety and efficacy of this regimen.

However, the feasibility of ultra-short radiation therapy treatments has already been demonstrated in an analogous treatment using high-dose rate (HDR) brachytherapy. HDR brachytherapy has been adopted at high volume cancers centers as a standard treatment for prostate cancer. Typical doses have been 26 - 27 Gy over 2 fractions (13 or 13.5 Gy per fraction). Overall, toxicity and efficacy of HDR brachytherapy have compared favorably to other treatment modalities.

Dosimetric planning models between SBRT and HDR brachytherapy suggest minor differences. HDR brachytherapy was able to achieve higher intraprostatic maximum doses and lower rectal doses, but target volume coverage and urethral dose was not significantly different. These data suggest that reducing SBRT treatments from 5 fractions to 2 fractions may be feasible, efficacious and tolerable.

Eligible patients include all patients who are otherwise eligible for standard 5 fraction SBRT prostate. Study population will be low and intermediate patients with good urinary function (as defined by small prostate volume and low IPSS score). SBRT treatment will be delivered to the prostate to 12.5 Gy x 2 fractions.

Hormonal therapy is permitted on this study. Permitted agents include: leuprolide (Lupron/Eligard), biclutamide (Casodex), and degarelix (Firmagon).

Rectal sparing with hydrogel spacer (SpaceOAR) will be encouraged.

All patients will be enrolled with interim safety analyses after every occurrence of a grade 3 acute or late toxicity. Interval safety analysis will also be performed for recurrence and decrease in EPIC GU domain quality of life. Biospecimen and financial toxicity data will also be collected.

Conditions

Early Stage Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hypofrac Radiation Therapy

All patients on this study will receive the same type of therapy, 2 treatment hypofractionated radiation therapy.

Radiation treatment will start approximately 1-2 weeks after the simulation scan. Prior to each treatment, you will be asked to have a full bladder and empty rectum. You will be asked to take a liquid diet starting the afternoon prior to each treatment, and a laxative (such as Miralax) in the evening prior to each treatment. You will also be asked to take a Fleet's enema about 1 hours prior to the treatment time to ensure that the rectum is empty. To ensure full bladder, you will be asked to drink about 32 oz of water after the enema. This is the same procedure as above for the prep before the simulation scan.

Each treatment should take about 10-20 minutes.

Group Type: EXPERIMENTAL

Hypofractionated Radiation

Intervention Type: RADIATION

All patients on this study will receive the same type of therapy, 2 treatment hypofractionated radiation therapy.

Interventions

Hypofractionated Radiation

All patients on this study will receive the same type of therapy, 2 treatment hypofractionated radiation therapy.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Ability of participant to sign a written informed consent.
• Diagnosed with prostate cancer, T1-T2bN0M0 GS6-7, PSA < 20
• IPSS score < 15 (and < 10 if on medication for benign prostatic hypertrophy such as tamsulosin) at time of enrollment (Appendix 21.4)
• Prostate volume (by US, CT or MRI measurement) < 50 cc at time of enrollment
• Androgen deprivation therapy based on clinician judgment is permitted on study
• Life expectancy > 10 years based on clinician's judgment
• No other active malignancy
• Age ≥ 18 years
• Performance Status Eastern Cooperative Oncology Group (ECOG) 0-1 (Appendix 21.5).
• Other study-specific criteria:
• Men of child-bearing potential must not donate sperm while on this study and for 90 days after their last study treatment.

NOTE: Acceptable forms of birth control are listed below:

• One Barrier method (cervical cap with spermicide plus male condom; diaphragm with spermicide plus male condom) PLUS
• Hormonal method (oral contraceptives, implants, or injections) or an intrauterine device (e.g., Copper-T).

Exclusion Criteria

• Current or anticipated use of other investigational agents while participating in this study.
• Psychiatric illness/social situations that would limit compliance with study requirements
• Prior pelvic radiation therapy
• Prior prostatectomy
• Inflammatory bowel disease or connective tissue disease requiring medical management

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Xinglei Shen

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xinglei Shen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center/ Cancer Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

IIT-2017-PROS-UltraHypoFracRT

Identifier Type: -

Identifier Source: org_study_id