NCT03056638

Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer

Terminated Phase 3 Results posted Last updated 28 August 2024

What this trial tests

Phase 3 trial testing Degarelix in Prostate Cancer in 56 participants. Terminated before completion.

Timeline

28 March 2017

Primary endpoint
16 August 2023

16 August 2023

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	56
Start date	28 March 2017
Primary completion	16 August 2023
Estimated completion	16 August 2023
Sites	10 locations across United States

Drugs / interventions tested

• Degarelix (degarelix) — full drug profile →
• stereotactic body radiosurgery (SBRT)

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Degarelix in Conjunction With Stereotactic Body Radiosurgery

Serious: 1/27 (4%)

Deaths: 1/27

Stereotactic Body Radiosurgery (SBRT)

Serious: 0/29 (0%)

Deaths: 0/29

Serious adverse events (1 terms)

Reaction	System	Degarelix in Conjunction W…	Stereotactic Body Radiosur…
Cardiac disorders - Other, specify	Cardiac disorders	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Degarelix in Conjunction W…	Stereotactic Body Radiosur…
Hyperglycemia	Metabolism and nutrition disorders	—	—
Lymphocyte count decreased	Investigations	—	—

Most-reported serious reactions: Cardiac disorders - Other, specify.

Data from ClinicalTrials.gov NCT03056638 adverse events section.

Sponsor's own description

Stereotactic body radiation therapy (SBRT) is a very precise form of radiation therapy that allows the physician to deliver more radiation dose in a single session. Because of this, the number of radiation sessions can be reduced from the typical 45-48 sessions, as in conventional daily session radiation, to 5 sessions given every other day over a week and a half. Giving the radiation at a higher dose during each treatment may be more effective in killing the prostate cancer cells than the standard way of using external radiation therapy where a small amount of radiation is given over many sessions.

Androgen Deprivation Therapy (ADT) or hormonal therapy is one of the methods to treat intermediate risk prostate cancer. This therapy works by reducing the level of testosterone and stopping them from affecting your cancer. The ADT used in this study is known as Degarelix. Degarelix is an approved medication that reduces the body's production of testosterone; this medication is usually given to all men with intermediate risk prostate cancer getting external radiation.

This study is a randomized study to find out whether combining stereotactic (also known as precision) radiation to the prostate cancer combined with a short course of Degarelix will result in a greater likelihood of killing the cancer in the prostate compared to stereotactic radiation therapy given alone. It has been shown that the combination of radiation with medications that interfere with testosterone production and its effects makes prostate cancer cells more sensitive to the radiation.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Stereotactic body radiotherapy with periprostatic hydrogel spacer for localized prostate cancer: toxicity profile and early oncologic outcomes.
   Hwang ME, Mayeda M, Liz M, Goode-Marshall B, et al · · 2019 · cited 35× · PMID 31375119 · DOI 10.1186/s13014-019-1346-5
2. Stereotactic Body Radiotherapy for Prostate Cancer.
   Parikh NR, Kishan AU. · · 2020 · cited 12× · PMID 32500805 · DOI 10.1177/1557988320927241
3. Stereotactic Radiation Therapy versus Brachytherapy: Relative Strengths of Two Highly Efficient Options for the Treatment of Localized Prostate Cancer.
   Kissel M, Créhange G, Graff P. · · 2022 · cited 8× · PMID 35565355 · DOI 10.3390/cancers14092226
4. Translating the Immunobiology of SBRT to Novel Therapeutic Combinations for Advanced Prostate Cancer.
   Adorno Febles VR, Blacksburg S, Haas JA, Wise DR. · · 2020 · cited 7× · PMID 32670868 · DOI 10.3389/fonc.2020.00830
5. Enhancing Androgen Deprivation Therapy (ADT) integration in prostate cancer: Insights for Stereotactic Body Radiotherapy (SBRT) and brachytherapy modalities.
   Gomez-Iturriaga A, Büchser D, Lopez-Campos F, Maldonado X. · · 2024 · cited 5× · PMID 38322544 · DOI 10.1016/j.ctro.2024.100733