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Hormone Therapy

Androgen deprivation therapy + Stereotactic ablative radiation for Prostate Cancer (KNIGHTS Trial)

Phase 2
Recruiting
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must have at least one and up to three asymptomatic metastatic tumor(s) of the bone, soft tissue, or extra-pelvic nodal region each < 5 cm or < 250 cm3 that develop within the past 6-months that are seen on imaging
Histologic confirmation of prostate adenocarcinoma (primary or metastatic tumor)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

KNIGHTS Trial Summary

This trial is comparing two treatments for recurrent metastatic prostate cancer. One treatment is the standard of care, which includes hormonal therapy and radiation to the metastatic lesions. The other treatment adds a combination of

Who is the study for?
This trial is for individuals with recurrent metastatic prostate cancer, specifically those who have a small number of secondary tumors (oligometastatic). Participants should be suitable for hormonal therapy and targeted radiation (SABR), but details on specific inclusion and exclusion criteria are not provided.Check my eligibility
What is being tested?
The study compares standard treatment (hormonal therapy + SABR) to the same standard care plus a 6-month course of niraparib/abiraterone acetate pills and prednisone. The goal is to see if adding these medications improves outcomes.See study design
What are the potential side effects?
Potential side effects may include issues related to hormonal changes from ADT, such as fatigue or sexual dysfunction; radiation side effects like skin irritation; and drug-related effects from niraparib/abiraterone like nausea, heart problems, or blood pressure changes.

KNIGHTS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have 1-3 small, symptom-free tumors outside the pelvis seen on scans in the last 6 months.
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My prostate cancer diagnosis was confirmed through a tissue sample.
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My prostate cancer is not responding to hormone therapy.
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I have a high-risk genetic mutation linked to cancer.
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I am able to get out of my bed or chair and move around.

KNIGHTS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PSA (Prostate Specific Antigen) evaluation at the 18-month progression of both treatment arms
Secondary outcome measures
Local control at 18 months after ADT+ SABR MDT (6-mos) vs ADT + SABR MDT + niraparib/abiraterone acetate and prednisone (6-mos) in patients with metachronous oligometastatic Castrate Specific Prostate Cancer (CSPC) disease.
Quality-of-life measured through EPIC tool following completion of ADT+ SABR MDT (6-mos) vs ADT + SABR MDT + niraparib/abiraterone acetate and prednisone (6-mos).
Time to locoregional progression, time to distant progression, time to new metastasis, radiographic progression-free survival and duration of response after randomization
+1 more

KNIGHTS Trial Design

2Treatment groups
Active Control
Group I: Androgen deprivation therapy + Stereotactic ablative radiationActive Control2 Interventions
Group II: Androgen deprivation therapy + Stereotactic ablative radiation + niraparib/abiraterone acetateActive Control3 Interventions

Find a Location

Who is running the clinical trial?

Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,430 Total Patients Enrolled
10 Trials studying Prostate Cancer
1,255 Patients Enrolled for Prostate Cancer
University of Maryland, BaltimoreLead Sponsor
688 Previous Clinical Trials
374,568 Total Patients Enrolled
12 Trials studying Prostate Cancer
511 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there ongoing efforts to actively enroll participants for this medical study?

"Based on the information provided by clinicaltrials.gov, it appears that this particular trial is not currently seeking participants. Although it was initially posted on March 1st, 2024 and last updated on January 16th, 2024, enrollment for this study is closed at present. However, there are an impressive number of 1336 other studies actively recruiting participants at this time."

Answered by AI

What is the level of safety associated with combining androgen deprivation therapy and stereotactic ablative radiation in individuals?

"Based on our assessment at Power, the safety of Androgen deprivation therapy + Stereotactic ablative radiation is rated as 2 on a scale from 1 to 3. This rating reflects that while there is some existing data supporting its safety, no evidence has been found yet regarding its efficacy in this Phase 2 trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
High-Risk Metachronous Oligometastatic Prostate Cancer Trial
Jason Molitoris, MD PhD 2024. "High-Risk Metachronous Oligometastatic Prostate Cancer Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06212583.
All > Metastatic Prostate Cancer
~59 spots leftby Dec 2028
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