Stereotactic Body Radiation Therapy for Prostate-Specific Antigen

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of California, San Francisco, San Francisco, CAProstate-Specific Antigen+3 MoreStereotactic Body Radiation Therapy - Radiation
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial is testing apalutamide with or without radiation therapy to see if it can effectively treat prostate cancer that is no longer responding to hormone therapy.

Eligible Conditions
  • Prostate-Specific Antigen Progression
  • Castration-resistant Prostate Cancer
  • Prostate Cancer (Stage IV)
  • Low Testosterone

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Up to 36 months

Month 18
Proportion of patients with undetectable serum prostate-specific antigen (PSA)
Up to 36 months
Frequency of treatment-related adverse events (AEs)
Median Time to PSA Progression

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Arm II (SBRT)
1 of 2
Arm I (apalutamide, SBRT)
1 of 2

Active Control

Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: Stereotactic Body Radiation Therapy · No Placebo Group · Phase 2

Arm I (apalutamide, SBRT)Experimental Group · 2 Interventions: Stereotactic Body Radiation Therapy, Apalutamide · Intervention Types: Radiation, Drug
Arm II (SBRT)
Drug
ActiveComparator Group · 1 Intervention: Apalutamide · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2019
Completed Phase 2
~650
Apalutamide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 36 months

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,312 Previous Clinical Trials
11,758,266 Total Patients Enrolled
Janssen PharmaceuticalsIndustry Sponsor
72 Previous Clinical Trials
18,929 Total Patients Enrolled
Rahul Aggarwal, MDPrincipal Investigator - University of California, San Francisco
UCSF Medical Center at Parnassus
Northwestern University Medical Sch (Medical School)
19 Previous Clinical Trials
1,261 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 22 Total Inclusion Criteria

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Frequently Asked Questions

Is this an innovative or revolutionary clinical trial?

"Since 2014, Aragon Pharmaceuticals have sponsored research into Stereotactic Body Radiation Therapy. Following a successful trial involving 982 people in that year, the drug received Phase 3 approval. Currently there are 44 active clinical trials for this therapy being conducted across 552 cities and 38 countries worldwide." - Anonymous Online Contributor

Unverified Answer

Is Stereotactic Body Radiation Therapy licensed by the FDA?

"Our assessment at Power assigned Stereotactic Body Radiation Therapy a score of 2, signifying there is evidence for its safety but not yet enough for efficacy." - Anonymous Online Contributor

Unverified Answer

Is there still an opportunity to join this clinical research?

"Affirmative. Information from clinicaltrials.gov reveals that this trial, first posted on December 17th 2019, is currently recruiting participants. Approximately 60 individuals are needed at 1 medical centre to take part in the research." - Anonymous Online Contributor

Unverified Answer

What has been the experience with Stereotactic Body Radiation Therapy in previous experiments?

"Presently, 44 trials for Stereotactic Body Radiation Therapy are in progress with 15 of those Phase 3. The majority of these tests take place at a single site in South Weymouth, Massachusetts; however, there are 2417 other locations running studies related to this therapy." - Anonymous Online Contributor

Unverified Answer

To what extent is participant recruitment for this clinical trial progressing?

"Affirmative. According to clinicaltrials.gov, this medical experiment is actively enrolling participants; it was first posted on December 17th 2019 and its most recent modification took place on August 29th 2022. Sixty individuals need to be recruited from a single site for the study's completion." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.