Trial Summary
What is the purpose of this trial?This phase II trial tests how well risk based de-escalated hormone therapy (i.e., fewer treatments) with radiation works in treating patients with prostate cancer. Androgen deprivation therapy (ADT), such as gonadotropin-releasing hormone analogs (LHRH) and abiraterone acetate (Zytiga), lower the amount of the male hormone, testosterone, made by the body. This may help kill or stop the growth of tumor cells that need testosterone to grow. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Research has shown that long-term ADT is beneficial for patients with high-risk prostate cancer. However, there are few studies that determine ADT treatment based on risk factors. Giving risk based de-escalated ADT with radiation therapy may be as effective as giving more ADT in treating high-risk prostate cancer.
Is the treatment combining hormone therapy and radiation promising for prostate cancer?Yes, combining hormone therapy with radiation is promising for prostate cancer. Studies show it improves survival rates, reduces the chance of cancer returning, and helps prevent the spread of cancer.13689
What safety data is available for hormone therapy and radiation in prostate cancer treatment?The safety data for hormone therapy (GnRH analogs like goserelin) combined with radiation therapy in prostate cancer treatment includes several findings: (1) Goserelin, when used with radiotherapy, has been shown to improve specific-symptom-free survival time in patients with locally advanced prostate cancer. However, it can cause endocrine disorders in 19% of patients, increased urinary incontinence, and almost always results in impotence and reduced libido. (2) GnRH analogs are generally considered safe and effective for managing hormone-dependent advanced prostate cancer, but they can cause initial flare-ups and other hormonal side effects. (3) Short-term use of LHRH antagonists before radiotherapy is standard, but the recovery of hormonal and sexual function post-treatment is still under study. (4) A phase I study explored testicular irradiation as an alternative to traditional androgen deprivation treatments, indicating ongoing research into safer treatment methods.24567
Do I need to stop my current medications for this trial?The trial protocol does not specify if you need to stop your current medications. However, if you are on anticoagulation therapy like warfarin, heparin, or Plavix, you may need to stop it to manage treatment-related toxicity or for certain procedures.
What data supports the idea that Hormone Therapy + Radiation for Prostate Cancer is an effective treatment?The available research shows that combining hormone therapy with radiation improves outcomes for prostate cancer patients. For example, one study found that using radiotherapy with a hormone treatment called GnRH analogue improved patient survival compared to using another hormone treatment called bicalutamide. Another study showed that combining radiation with a hormone treatment called LHRH analog improved survival rates and reduced the chances of cancer returning or spreading. These findings suggest that hormone therapy plus radiation is an effective treatment for prostate cancer.16789
Eligibility Criteria
This trial is for individuals with prostate cancer, specifically adenocarcinoma. Participants should be suitable for hormone therapy and radiation, and willing to undergo various imaging tests like CT, MRI, PET scans, as well as provide biospecimens. The study aims to tailor the amount of hormone treatment based on individual risk factors.Treatment Details
The trial is testing a de-escalated (reduced) approach to hormone therapy combined with radiation in treating prostate cancer. It involves using drugs that lower testosterone levels (like LHRH analogs and Zytiga) alongside high-energy treatments aimed at killing cancer cells or shrinking tumors.
3Treatment groups
Experimental Treatment
Group I: Group III (ADT, radiation therapy, abiraterone acetate)Experimental Treatment8 Interventions
Patients receive ADT SC or IM with or without abiraterone acetate for up to 18 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy to identified areas over 2 - 6 weeks starting on week 8-10 of ADT hormone therapy. Additionally, patients undergo PET, CT or MRI and blood sample collection throughout the study.
Group II: Group II (ADT, radiation therapy)Experimental Treatment7 Interventions
Patients receive ADT SC or IM for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy to the prostate bed over 2 - 6 weeks starting on week 8-10 of ADT hormone therapy. Additionally, patients undergo PET, CT or MRI and blood sample collection throughout the study.
Group III: Group I (radiation therapy)Experimental Treatment6 Interventions
Patients undergo radiation therapy to the prostate bed over 2 - 6 weeks. Additionally, patients undergo PET, CT or MRI and blood sample collection throughout the study.
Gonadotropin-releasing Hormone Analog is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as GnRH analog for:
- Prostate cancer
- Endometriosis
- Uterine fibroids
- Precocious puberty
🇪🇺 Approved in European Union as LHRH analog for:
- Prostate cancer
- Endometriosis
- Uterine fibroids
- Precocious puberty
🇨🇦 Approved in Canada as GnRH analog for:
- Prostate cancer
- Endometriosis
- Uterine fibroids
- Precocious puberty
🇯🇵 Approved in Japan as LHRH analog for:
- Prostate cancer
- Endometriosis
- Uterine fibroids
- Precocious puberty
Find a clinic near you
Research locations nearbySelect from list below to view details:
Mayo Clinic in ArizonaScottsdale, AZ
Loading ...
Who is running the clinical trial?
Mayo ClinicLead Sponsor
References
[Current studies of combined radiotherapy-hormone therapy in localized and locally advanced prostatic cancers]. [2019]In locally advanced prostate cancer three clinical randomized trials have shown that external irradiation combined with LHRH analogue with or without antiandrogen improved survival: disease-free survival, local recurrence-free survival, metastasis-free survival (P
Goserelin and locally advanced prostate cancer: new indication. Pros and cons. [2013](1) Goserelin, a GnRH agonist, has a new licensed indication in France, as an adjuvant to external radiotherapy for locally advanced prosate cancer. (2) The clinical file in this indication includes two trials of satisfactory methodological quality comparing radiotherapy + goserelin with radiotherapy alone. (3) In these trials the radiotherapy + goserelin combination increased the specific-symptom-free survival time. (4) In one trial goserelin caused endocrine disorders in 19% of patients. There were also more cases of urinary incontinence (13% in absolute values) among patients receiving the radiotherapy + goserelin combination. Furthermore, goserelin almost always causes impotence and reduced libido.
Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. [2022]We did a randomised phase III trial comparing external irradiation alone and external irradiation combined with an analogue of luteinising-hormone releasing hormone (LHRH) to investigate the added value of long-term androgen suppression in locally advanced prostate cancer.
No supra-additive effects of goserelin and radiotherapy on clonogenic survival of prostate carcinoma cells in vitro. [2022]Oncological results of radiotherapy for locally advanced prostate cancer (PC) are significantly improved by simultaneous application of LHRH analoga (e.g. goserelin). As 85% of PC express LHRH receptors, we investigated the interaction of goserelin incubation with radiotherapy under androgen-deprived conditions in vitro.
Clinical pharmacology and regulatory consequences of GnRH analogues in prostate cancer. [2022]GnRH (gonadotropin-releasing hormone) analogues are long-term known to be safe and effective in the clinical management of hormone-dependent advanced prostate cancer. However, their unusual mechanism of action of de-sensitizing pituitary receptors makes generic market entry challenging. In addition, safety aspects like initial flare-up, breakthrough escape, and miniflares render planning and organization of clinical registration trials a complex project.
Prospective phase I study on testicular castration induced by radiation treatment. [2018]Surgery and luteinizing hormone-releasing hormone (LHRH) analogs are standard androgen deprivation treatments (ADT) for patients with advanced prostate cancer. We performed a phase I study to explore if irradiation to the testes could be used as an alternative to ADT.
Recovery of Serum Testosterone Levels and Sexual Function in Patients Treated With Short-term Luteinizing Hormone-releasing Hormone Antagonist as a Neoadjuvant Therapy Before External Radiotherapy for Intermediate-risk Prostate Cancer: Preliminary Prospective Study. [2019]External beam radiation therapy (EBRT) with short-term androgen deprivation therapy is the standard of care for intermediate-risk prostate cancer patients. However, no study to date has evaluated the hormonal kinetics or sexual and hormonal function recovery after cessation of short-term luteinizing hormone (LH)-releasing hormone (LHRH) antagonist treatment.
Radiotherapy Plus Total Androgen Block Versus Radiotherapy Plus LHRH Analog Monotherapy for Non-metastatic Prostate Cancer. [2018]Patients with locally advanced prostate cancer are generally treated with radiotherapy (RT) which can be combined with hormonal therapy. RT plus monotherapy with luteinizing hormone-releasing hormone (LHRH) analog triptorelin was compared to RT plus total androgen block (TAB).
Radiotherapy Plus GnRH Analogue Versus High Dose Bicalutamide: A Case Control Study. [2020]Radiotherapy (RT) with adjuvant hormone therapy (HT) improves prognosis in prostate cancer (PC) patients. Gonadotrophin-releasing hormone agonist (GnRHa) with luteinizing hormone-releasing hormone (LH-RH) analogues is the standard HT. High-dose antiandrogen therapy also improves survival in patients with locally advanced PC. The aim of this study was to compare the results of patients treated with RT plus GnRHa and patients treated with RT plus bicalutamide.