Safety of Dose Escalation in Definitive Hypofractionated Radiation Therapy and Hormone Therapy With SpaceOAR TM for Patients With High - Risk Localized Prostate Cancer (DESAR-H) (DESAR-H)

June 19, 2024 updated by: Won Park, Samsung Medical Center
Dose increase after injection of biodegradable material A safety study of high-risk prostate cancer patients who underwent low-fractionation curative radiation therapy and hormone therapy

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In prostate cancer, radiation therapy for curative purposes can be used regardless of the stage if there is no distant metastasis, and radiation therapy and hormone therapy may be combined in patients with moderate or high risk factors for recurrence. Randomized prospective studies to investigate the therapeutic effect of increasing dose escalation to 70 Gy or more showed significant reductions 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: EQD1 (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 Gy, 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 performs biodegradable material injection before radical radiotherapy in combination with hormone therapy in high - risk prostate cancer patients. The investigator plans to conduct a phase II clinical study to evaluate the safety of high - risk prostate cancer patients who has received subdivision radical radiation therapy with hormone therapy.

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. Histopathologically confirmed prostate adenocarcinoma within 6 months of study enrollment
  2. Patients with prostate cancer at high risk or above (c T3a-T4 or grade group 4-5 or PSA > 20 n g/mL) )
  3. Patients who have undergone or are scheduled to undergo hormone therapy for high-risk prostate cancer
  4. Adults over 20 years of age
  5. Whole body performance ECOG 0-1
  6. SpaceOAR Patients who consented to the procedure and study

Exclusion Criteria:

  1. prostate removal surgery, 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. Patients with a history of previous pelvic radiation therapy
  5. Patients with lymph node metastasis or distant metastasis

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, we plan to evaluate grade 1 or higher rectal bleeding within 3 years in high-risk prostate cancer patients who received biodegradable substance injection followed by curative radiotherapy in combination with hormone therapy.
Radiation: Dose increase after injection of biodegradable material A safety study of high-risk prostate cancer patients
this researcher performed biodegradable material injection during radical radiotherapy in combination with hormone therapy in high - risk prostate cancer patients. 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: 3 years after radiation therapy of each participant
Adverse Event within three years after the radiation therapy
3 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: up to 2 years afte radiation therapy on each participant
Sigmoi doscopy is performed once a year for up to 2 years after the end of radiation therapy,
up to 2 years afte radiation therapy on each participant
Side effects related to biodegradable material injection
Time Frame: each participant finished with radiation therapy and see after 3-6 months for acute adverse events, 1-5 years for chronic adverse events
each participant finished with radiation therapy and see after 3-6 months for acute adverse events, 1-5 years for chronic adverse events
biochemical recurrence-free survival
Time Frame: 5 years after radiation therapy of each participant
Biochemical recurrence is defined as PSA nadir + 2.0ng/ml according to the Phoenix definition, or when hormone therapy is discontinued, when hormone therapy is newly started, or when hormone therapy is in progress, when the treatment is changed.
5 years after radiation therapy of each participant
progression-free survival
Time Frame: up to 5 years after radiation therapy of each participant
check on each participant by CT scan, MRI, Bone scan for any progressive disease
up to 5 years after radiation therapy of each participant
overall survival
Time Frame: up to 5 years after radiation therapy of each participant
overall survival of participants till the end of the study(death)
up to 5 years after radiation therapy of each participant
quality of life on high-risk prostate cancer patients by using EPIC questionnaire
Time Frame: up to 5 years after radiation therapy of each participant
EPIC (Extended Prostate Cancer Index Composite), Korean version
up to 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)

September 12, 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 2023-06-140

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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