Safety of Dose Escalation in Definitive Hypofractionated Radiation Therapy With SPACEOAR TM for Patients With Low-to-intermediate Risk Localized Prostate Cancer (DESAR-L) (DESAR-L)

June 19, 2024 updated by: Won Park, Samsung Medical Center
A single institution with a single group, a phase II study, low- and medium-risk studies performed after biodegradable substance injection prostate cancer dosage increase. The investigator plans to evaluate grade 1 or higher rectal bleeding occurring within 3 years in patients who have received low -fractionation curative radiotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In prostate cancer, radiation therapy for curative purposes can be used regardless of stage if there is no distant metastasis. For prostate cancer patients with low-and medium risk, radiotherapy is recommended as standard treatment along with surgery. In randomized prospective studies to investigate the therapeutic effect of dose escalation over 70 Gy during radiation therapy, increasing dose showed a significant reduction in biochemical failure. When the dose is increased, the risk of side effects (digestive system, urinary system) in surrounding normal tissues increases, and intensity modulated radiation therapy (IMRT) or image-guided radiation therapy (IGRT) Application could reduce the probability of side effects. Prostate cancer is a carcinoma characterized by slow growth, and the estimated α/β ratio is 1.5, which is smaller than surrounding normal tissues such as the bladder (4.0) and the rectum (3.9). Therefore, efforts to obtain therapeutic gain through hypofractionated radiation therapy have been attempted using three-dimensional conformal radiotherapy (3D-CRT) and IMRT. In particular, in the CHHIP trial11 announced in 2016, normal division Radiation therapy (74 Gy, 37 splits ) and As a result of comparing low-fractionation radiation therapy (60 Gy, 20 fractions ), there was no significant difference in the 5-year biochemical or clinical recurrence -free survival rate of low-fractionation radiation therapy, it was also reported that there was no difference in rectal and bladder side effects. However, rectal and bladder side effects of grade 2 or higher were 11.9% and 11.7 % during one-time 3 Gy low-fractionated radiotherapy, respectively. The low-fractionated radiotherapy dose is 81 Gy, which is the recommended normal fractionated radiotherapy dose when using IMRT. It can be said that there is a high possibility of showing inferior treatment results in long-term follow-up results because the biological effective dose is lower than that of 'ideal'. (Table 1)

  • Table 1 . Biological Equivalent Dose by Radiation Therapy Policy(2-Gy fraction) comparison
  • Protocol: EQD2 (Gy) (α/β=1.5)
  • Low-fraction radiation therapy(70 Gy, 28 sessions): 80.0 Gy
  • Conventional fractionation radiation therapy(74 Gy, 37 times): 74 Gy
  • CHHIP trial(60 G y, 20 times): 77. 14 Gy
  • study design dose(64 Gy, 20 times): 85.94 Gy *EQD2, equivalent dose in 2-Gy fractions

Recently, a method was devised to increase the distance between prostate and rectum by injecting hydrogel between prostate and rectum to minimize rectal dose even when performing high-dose radiotherapy to prostate. In particular, a biodegradable material ( SpaceOAR (hydrogel)) that is absorbed into the body after a certain period of time has been developed, and radical radiation therapy is performed. It is currently being used in prostate cancer patients. It is judged possible to try to increase the radiation dose because the side effects can be reduced by reducing the rectal dose during radical radiation treatment through biodegradable material injection. So far, studies evaluating the side effects of treatment according to increased radiation dose after injection of biodegradable materials are very limited.

Therefore, the investigator uses a biodegradable material injection technique follows by subdivision radical received radiation therapy. The investigator plans to conduct a phase II clinical study to evaluate the safety of prostate cancer patients.

Study Type

Interventional

Enrollment (Estimated)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Prostate cancer patients confirmed histopathologically within 6 months prior to study enrollment
  2. Low-risk and medium- risk groups in terms of risk Prostate cancer patients (primary stage T2c or less, Grade group 3 or less, If PSA is less than 20ng/ml)
  3. Adults over 20 years of age
  4. Whole body performance ECOG 0-1
  5. SpaceOAR Patients who consented to the procedure and the clinical study

Exclusion Criteria:

  1. Prostatectomy, Patients with a history of lower pelvic surgery including rectal cancer surgery
  2. primary cancer Patients with posterior extracapsular extension
  3. Medically biodegradable substances such as bleeding predisposition Patients for whom infusion is not appropriate
  4. Biodegradable material Patients who failed infusion
  5. Patients with a history of previous pelvic radiation therapy
  6. Patients with distant metastasis and intrapelvic lymph node metastasis
  7. Patients who have undergone or are scheduled to undergo hormone therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prostate cancer patient, candidate of definitive radiation treatment
A single institution with a single group, a phase II study, Low- and medium-risk studies performed after biodegradable substance injection prostate cancer dose increase.
Radiation: Low- and medium-risk studies performed after biodegradable substance injection prostate cancer dose increase.
this researcher used a biodegradable material injection technique. after subdivision radical received radiation therapy We plan to conduct a phase II clinical study to evaluate the safety of prostate cancer patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) V 5.0 Frequency of rectal bleeding of grade 1 or higher within 3 years
Time Frame: 5 years after radiation therapy of each participant
NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) V 5.0
5 years after radiation therapy of each participant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation therapy-related side effects other than rectal bleeding
Time Frame: 5 years after each participant's end of radiation therapy after SpaceOAR hydrogel injection
Radiation therapy-related side effects other than rectal bleeding
5 years after each participant's end of radiation therapy after SpaceOAR hydrogel injection
Side effects related to biodegradable material injection
Time Frame: 5 years after radiation therapy of each participant
Side effects related to biodegradable material injection
5 years after radiation therapy of each participant
5-year biochemical recurrence-free survival
Time Frame: 5 years after radiation therapy of each participant
5-year biochemical recurrence-free survival
5 years after radiation therapy of each participant
5-year progression-free survival
Time Frame: 5 years after radiation therapy of each participant
5-year progression-free survival
5 years after radiation therapy of each participant
5-year overall survival
Time Frame: 5 years after radiation therapy of each participant
5-year overall survival
5 years after radiation therapy of each participant
quality of life in every aspect of life
Time Frame: 5 years after radiation therapy of each participant
quality of life using Questionnare EPIC ( Extended Prostate Cancer Index Composite)
5 years after radiation therapy of each participant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2023

Primary Completion (Estimated)

December 31, 2033

Study Completion (Estimated)

December 31, 2033

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 17, 2024

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 19, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC 2023-06-143

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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