Degarelix & Relugolix for Prostate Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur, GA
Prostate Cancer+5 More
Degarelix & Relugolix - Drug
Eligibility
18+
Male
Eligible conditions
Prostate Cancer

Study Summary

This study is evaluating whether a surgery or radiation therapy may help treat prostate cancer.

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Eligible Conditions

  • Prostate Cancer
  • Prostatic Neoplasms
  • Oligometastasis
  • Prostate Cancer - Recurrent
  • refractory, metastatic hormone-refractory Prostate cancer
  • Oligorecurrence

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Degarelix & Relugolix will improve 1 primary outcome and 10 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of 2 years.

2 years
Expanded Prostate cancer Index Composite Short Form (EPIC-26)
Patient-reported health-related quality of life measured by the EQ5D-5L
Patient-reported quality of life measured by the EORTC QLQ-C30 3.0
4 years
Castration-resistant prostate cancer-free survival (CRPC-free survival)
Clinical progression-free survival (cPFS)
Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 toxicity
Freedom from index lesion progression (FFILP)
New metastasis-free survival (MFS)
Overall survival (OS)
Prostate cancer-specific survival (PCSS)
Radiographic progression-free survival (rPFS)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Standard Systemic Therapy (SST)
SST + PET-directed local therapy

This trial requires 464 total participants across 2 different treatment groups

This trial involves 2 different treatments. Degarelix & Relugolix is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

SST + PET-directed local therapyIn addition to SST, all Veterans will receive PET-directed local therapy to all metastases using surgery or radiation. The selection of surgery or radiation to each metastasis will be determined using shared decision-making between the physician and Veteran. For Veterans with a local recurrence, this will be treated with salvage local therapy.
Standard Systemic Therapy (SST)All Veterans will receive SST
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Degarelix
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4 years for reporting.

Closest Location

Atlanta VA Medical and Rehab Center, Decatur, GA - Decatur, GA

Eligibility Criteria

This trial is for male patients aged 18 and older. You must have received 1 prior treatment for Prostate Cancer or one of the other 5 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You have had a local therapy for prostate cancer that was curative show original
You have a history of metastatic disease and imaging studies show evidence of metastasis. show original
Ability to provide Informed Consent for participation in the study.
ECOG Performance Status </= 2 at time of enrollment.
Any T-classification, Gleason Grade Group, and pre-treatment PSA at the time of initial curative-intent treatment are acceptable.
Nx, N0, or N1 N-classification at the time of curative-intent local therapy. show original
No metastatic disease at the time of intent treatment are acceptable
No metastatic disease at the time of initial curative-intent treatment are acceptable. show original
PSA >/= 0.2 ng/ml x 2 after prostatectomy +/- post-operative radiotherapy
You have had definitive radiotherapy. show original

Patient Q&A Section

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

What are common treatments for prostate cancer?

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Radical prostatectomies do not always provide satisfactory oncologic outcomes. Radical prostatectomy is an effective treatment for patients with localized prostate cancer but does not affect survival in the whole or in intermediate-risk patients.

Unverified Answer

How many people get prostate cancer a year in the United States?

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It was estimated that there were about 1,300,000 men with prostate cancer in the United States in 2016 and about 2,100,000 men with prostate cancer will develop prostate cancer within their lifetime. It appears that men in this nation may have a longer life expectancy with prostate cancer compared with men in developed countries. The increase in prostate cancer incidence in the USA is mostly confined to males born after World War II.

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What causes prostate cancer?

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The etiological basis for prostate cancer remains relatively unknown. The present data do not support a link between familiality and prostate cancer. The study group had fewer cases of Gleason score greater than 7. We suggest that there may not be a definitive link between prostate cancer and familial cases, as this is just one case control study, but we cannot rule out the possibility in large studies, however, such as the aforementioned large database study.

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Can prostate cancer be cured?

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In our experience, the most important factors for the prognosis of prostate cancer are age, stage, PSAD, Gleason score and PSA. Furthermore, the PSA assay should be included as an additional stratifying marker, both when designing treatment strategy and prognostic indices. Results from a recent clinical trial of the current trials will have a decisive impact on the treatment of PCa.

Unverified Answer

What is prostate cancer?

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Men with prostate cancer are characterized by high levels of serum PSA, low risk of local lymph node metastasis (LNM and T2G Gleason grading), and an extremely low risk of death from prostate cancer.

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What are the signs of prostate cancer?

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A minority (12%) of men without prostate cancer and no men with prostate cancer had symptoms. Men with prostate cancer did have signs of the disease but tended to have smaller and slower growing tumours, which were typically of a lower grade and were more likely to present without symptoms.

Unverified Answer

What are the common side effects of adt + nilutamide, flutamide, & bicalutamide?

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Overall, both ADT and FLUTERID were well tolerated by patients treated for prostate cancer with them. Among the side effects documented here, only increased ALT and AST were dose-related during treatment with both FLUTERIDA and ADT alone, whereas increased AST/ALT was associated with FLUTERID plus ADT. Furthermore, when the cumulative incidence of hepatic toxicity is plotted, ADT monotherapy is associated with the greatest hepatoxicity and the greatest need for hepatic-directed therapy.

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What are the latest developments in adt + nilutamide, flutamide, & bicalutamide for therapeutic use?

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For nearly a decade the addition of bicalutamide has had no role in the treatment of the metastatic form of testicular cancer. However, in June 2013, a two-step-approval from FDA, which had been delayed by several years, has enabled this drug to be introduced as an alternative to flutamide or nilutamide in the metastatic form of testicular cancer.

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What is the primary cause of prostate cancer?

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As indicated already, the current epidemiology data suggest that [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) develops, in men, from benign disease or at least from the precursor stage. There is an interrelationship between both components of the multifactorial etiology of advanced prostate cancer. In the presence of high PSA levels, a prostate biopsy is indicated (as an confirmator). In low PSA levels, further testing, e.g. the prostate-specific antigen test, is needed to differentiate prostate cancer from BPH.

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Have there been any new discoveries for treating prostate cancer?

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While the first treatment available in the past several decades was radical prostatectomy, more recent methods include active surveillance and radiotherapy. In addition, the field of prostate reconstruction is rapidly developing to satisfy the increasing demand for natural, tissue-like-looking prostheses. Although treatment strategies are constantly changing, surgical treatment for prostate cancer remains an adequate therapeutic option for patients with localized disease. The treatment of early-stage metastatic prostate cancer continues to be a challenge, and new therapeutic methods are being investigated. Current therapeutic options include radiation therapy, hormonal therapy and chemotherapy. In particular, hormonal therapy is an attractive alternative to conventional chemotherapy, with long-term survival rates in the range of 80-90%.

Unverified Answer

Is adt + nilutamide, flutamide, & bicalutamide safe for people?

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Recent findings, the addition of either nilutamide or adt plus biflutamide to flutamide did not affect overall completion rates with no reported increased toxicity rates.

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Has adt + nilutamide, flutamide, & bicalutamide proven to be more effective than a placebo?

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Results from a recent paper did not find a treatment difference between the treatments tested in this study (ADT+ NILUT) when comparing outcomes from these two treatments in this specific subgroup of men with lower-risk, locally advanced prostate cancer.

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