Two-fraction Versus Five-fraction Stereotactic Radiotherapy for Localized Prostate Cancer

NCT06027892 | Recruiting DMC

• 2 other identifiers: RMC-0199-22MOH_2022-08-30_012007
• Study Type: interventional
• Target: 562
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare two dose schedules of stereotactic radiation therapy in patients with localized prostate cancer. Historically, external beam radiation to treat localized prostate cancer was given in small treatments over a period of multiple weeks. Recent studies have shown that with newer technologies and better understanding of how prostate cancer responds to radiation, the same effective dose can be given in as few as 5 treatments. This study is comparing this newer standard course of 5 treatments with an even shorter course of just 2 treatments. The dose for the 2 treatments is based on a form of internal radiation called brachytherapy, but in this study, that dose will be given using external radiation, without the need for invasive procedures. In order to make sure that the radiation therapy is given in a way that minimizes the risk of side effects to the surrounding organs, including the rectum and bladder, prior to radiation a hydrogel material will be inserted behind the prostate in order to distance the rectum further from the prostate gland, and small gold markers will be inserted into the prostate to decrease any possible movement during treatment. The main questions are whether 2-treatment radiation is tolerated as well and is as effective at treating prostate cancer, compared to the standard 5-treatment course of radiation.

Conditions

PROSTATE CANCER

Outcome Measures

Primary Outcomes (1)

• Biochemical Progression Free Survival

  Phoenix definition

  five-year

Secondary Outcomes (7)

• Freedom From Progression

  five-year

• Distant metastasis free survival

  five-year

• Prostate cancer specific survival

  five-year

• Time to prostate specific antigen nadir (< 0.2) - Longitudinal response

  five-year

• Time to salvage treatment

  five-year

Study Arms (2)

Two-fraction stereotactic radiotherapy

EXPERIMENTAL

Participants receive stereotactic ablative radiotherapy in two treatments to a dose of 27 Gy, with the options to boost a high-grade lesion to 30 Gy

Radiation: Two-fraction stereotactic radiotherapy

Five-fraction stereotactic radiotherapy

ACTIVE COMPARATOR

Participants receive stereotactic ablative radiotherapy in five treatments to a dose of 40 Gy, with the options to boost a high-grade lesion to 45 Gy

Radiation: Five-fraction stereotactic radiotherapy

Interventions

Two-fraction stereotactic radiotherapy RADIATION

Definitive prostate radiotherapy will be delivered to a dose biologically comparable to 40 Gy in 5 treatments, but in only 2 treatments

Two-fraction stereotactic radiotherapy

Five-fraction stereotactic radiotherapy RADIATION

Definitive prostate radiotherapy will be delivered to a standard stereotactic dose of 40 Gy in 5 treatments

Five-fraction stereotactic radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients ≥18 years
• Diagnosis of low- or favorable intermediate-risk prostate adenocarcinoma
• T1-T2c
• Prostate specific antigen \< 20
• Gleason 6 or 7 (3+4)
• Cannot had multiple intermediate-risk factors consistent with unfavorable intermediate risk disease
• Prostate gland \< 60 cc (can include following cytoreductive androgen deprivation)
• International Prostate Symptom Score \< 15 (unaided by a-adrenergic inhibitor or anticholinergic drugs)

You may not qualify if:

• Unfavorable intermediate-risk disease and above
• Chronic inflammatory bowel condition (IBD, Crohn's disease, Sarcoidosis, Rheumatic disease)
• Chronic immunosuppression
• Contraindications to hydrogel spacer placement
• Contraindications to a prostate MRI
• Any prior prostate cancer treatment
• Prior pelvic radiotherapy
• Previous transurethral resection of the prostate (TURP) within 12 months
• Hip prosthesis
• Prior use of therapeutic androgen deprivation therapy

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Davidoff Cancer Center, Rabin Medical Center

Petah Tikva, Israel, 49100, Israel

RECRUITING

Related Publications (21)

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  PMID: 38589860 DERIVED

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

Study Officials

• Elisha T Fredman, MD

  Davidoff Cancer Center, Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisha T Fredman, MD

CONTACT

9148744461; elishafre@clalit.org.il

Assaf Moore, MD

CONTACT

assafmo1@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 7, 2023
• Study Start: December 29, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2032
• Last Updated: November 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Individual participant data and supporting information will be made upon request through final publication of the study results
• Access Criteria: Access will be granted by the leading study PI upon request by participating researchers, based on the needs and length of time necessary.

Locations

IL (1)