Hormone Therapy + Radiation for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Carlos E. Vargas, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Mayo Clinic

Must be taking: Androgen deprivation therapy

Must not be taking: Anticoagulants

Disqualifiers: Pelvic radiation, Chemotherapy, Anticoagulation, others

No Placebo Group

Prior Safety Data

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on certain blood thinners like warfarin or heparin unless they can be stopped for treatment-related reasons.

What data supports the effectiveness of the treatment Hormone Therapy + Radiation for Prostate Cancer?

Research shows that combining radiotherapy with hormone therapy, such as LHRH analogs, improves survival rates in prostate cancer patients by reducing the risk of disease recurrence and spread.

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Is hormone therapy combined with radiation generally safe for prostate cancer treatment?

Hormone therapy with GnRH analogs like goserelin, combined with radiation, is generally considered safe for treating prostate cancer, but it can cause side effects such as endocrine disorders, urinary incontinence, impotence, and reduced libido.

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How is the treatment of hormone therapy combined with radiation unique for prostate cancer?

This treatment combines hormone therapy using GnRH analogs (which lower testosterone levels) with radiation therapy to improve survival rates in prostate cancer patients. The combination has been shown to enhance disease-free survival and reduce the risk of cancer spreading compared to radiation alone.

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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.

Inclusion Criteria

I am 18 years old or older.

Patients must sign institutional review board (IRB) approved study specific informed consent

Patients must complete all required pre-entry tests

Exclusion Criteria

I have had radiation therapy to my pelvic area before.

I have been on hormone therapy for prostate cancer for over 6 months.

I do not have active rectal problems like diverticulitis, Crohn's, or ulcerative colitis.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive risk-based de-escalated hormone therapy (ADT) and radiation therapy. Group I undergoes radiation therapy for 2-6 weeks. Group II receives ADT for up to 12 months and radiation therapy starting on week 8-10. Group III receives ADT with or without abiraterone acetate for up to 18 months and radiation therapy starting on week 8-10.

2-18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at months 3 and 12, then yearly for up to year 5, followed by every 2 years.

5 years

Participant Groups

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.

Group I: Group III (ADT, radiation therapy, abiraterone acetate) Experimental Treatment 8 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 Treatment 7 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 Treatment 6 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 Nearby Select from list below to view details:

Mayo Clinic in Arizona Scottsdale, AZ

Who Is Running the Clinical Trial?

Mayo Clinic Lead Sponsor

References

1. Canada pubmed.ncbi.nlm.nih.gov

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.

2. United States pubmed.ncbi.nlm.nih.gov

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.

3. Greece pubmed.ncbi.nlm.nih.gov

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.

4. Greece pubmed.ncbi.nlm.nih.gov

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).

5. France pubmed.ncbi.nlm.nih.gov

[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

6. England pubmed.ncbi.nlm.nih.gov

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.

7. Germany pubmed.ncbi.nlm.nih.gov

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.

8. France pubmed.ncbi.nlm.nih.gov

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.

9. England pubmed.ncbi.nlm.nih.gov

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.