Radiation and Hormone Therapy for Prostate Cancer
(OCEAN Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Miami
Must be taking: Androgen suppression
Must not be taking: Androgen deprivation, Chemotherapy
Disqualifiers: Bone metastasis, Visceral metastasis, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?The purpose of this prostate cancer research study is to learn about:
1. Improving control of prostate cancer using radiation therapy, delivered to the para-aortic and pelvic lymph nodes, in addition to systemic androgen suppression therapy;
2. Preserving quality of life after radiation therapy;
3. Leveraging imaging results from prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) scans to evaluate and manage disease progression.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should not have had androgen deprivation therapy or chemotherapy in the three months prior to the study.
What data supports the effectiveness of this treatment for prostate cancer?
Research shows that combining androgen deprivation therapy (ADT) with radiation therapy improves survival for men with locally advanced prostate cancer. Additionally, more potent androgen receptor inhibitors may enhance outcomes when used with radiation therapy in high-risk cases.
12345Is radiation and hormone therapy for prostate cancer safe?
Radiation and hormone therapy, often called androgen deprivation therapy (ADT), is commonly used for prostate cancer but can have side effects affecting the body's metabolism, muscles, heart, brain, and sexual function. While these side effects can be serious, they are often managed with careful monitoring and patient education to improve quality of life.
12367How is the treatment of radiation and hormone therapy for prostate cancer unique?
This treatment combines radiation with hormone therapy, specifically targeting androgen receptors (proteins that bind male hormones), which is a unique approach because it blocks hormone signals that prostate cancer cells need to grow. This combination can improve outcomes by enhancing the effectiveness of radiation therapy, especially in high-risk cases, and may allow for shorter-term hormone therapy with potentially fewer side effects.
3891011Eligibility Criteria
Men with prostate cancer that has spread to a limited number of spots in the lymph nodes may join this trial. They should be fit for hormone therapy and radiation, and have had PSMA PET/CT scans showing disease progression.Inclusion Criteria
Willingness to fill out quality of life and psychosocial forms
My prostate cancer responds to hormonal therapy.
My lymph node tumor is smaller than 5 cm.
+10 more
Exclusion Criteria
I am unable to make medical decisions for myself.
My cancer has a large tumor over 5 cm in size.
No staging with PSMA PET/CT scan
+14 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Systemic Therapy
Participants undergo up to six months of systemic androgen deprivation therapy (ADT) and Androgen receptor signaling inhibitor (ARSI)
24 weeks
Radiation Therapy
Participants receive five weeks of para-aortic radiation therapy
5 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including progression-free survival and quality of life assessments
Up to 2 years
Participant Groups
The study is testing if targeting para-aortic lymph nodes with proton or photon radiation, alongside hormone suppression therapy and an androgen receptor signaling inhibitor, can better control prostate cancer while maintaining quality of life.
1Treatment groups
Experimental Treatment
Group I: PSMA-Guided PA-RT GroupExperimental Treatment4 Interventions
Participants in this group will undergo up to six months of systemic androgen deprivation therapy (ADT) and Androgen receptor signaling inhibitor (ARSI). During system therapy, participants will undergo five weeks of para-aortic radiation therapy.
Total participation duration is up to five years.
Androgen Deprivation Therapy is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Androgen Deprivation Therapy for:
- Prostate cancer
- Metastatic prostate cancer
- Recurrent prostate cancer
🇺🇸 Approved in United States as Androgen Deprivation Therapy for:
- Prostate cancer
- Metastatic prostate cancer
- Recurrent prostate cancer
- Localized prostate cancer
🇨🇦 Approved in Canada as Androgen Deprivation Therapy for:
- Prostate cancer
- Metastatic prostate cancer
- Recurrent prostate cancer
- Localized prostate cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MiamiMiami, FL
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Who Is Running the Clinical Trial?
University of MiamiLead Sponsor
References
The timing and extent of androgen deprivation therapy for prostate cancer: weighing the clinical evidence. [2019]Androgen deprivation therapy (ADT) is an effective means of palliating symptoms of prostate cancer but is associated with significant toxicities that increase with treatment duration. Primary ADT in men with localized disease provides no survival advantage. Neoadjuvant ADT, when combined with external beam radiation, improves survival for men with locally advanced disease. Immediate adjuvant androgen deprivation does not seem to benefit most men undergoing radical prostatectomy. No evidence supports combined androgen blockade or monotherapy with nonsteroidal antiandrogens for locally advanced prostate cancer. ADT with orchiectomy or gonadotropin-releasing hormone agonists or antagonists is standard care for men with metastatic prostate cancer.
The evolving role of androgen deprivation therapy in the management of prostate cancer. [2017]Androgen deprivation therapy (ADT) plays a central role in the management of prostate cancer. ADT is the mainstay of treatment for metastatic disease; the most common method is gonadal suppression via luteinizing hormone release hormone (LH) agonists, with or without antiandrogens. Antiandrogen monotherapy remains investigational, as is the appropriate role of 5alphareductase inhibition for prostate cancer. Intermittent ADT offers the promise of improved quality of life and reduced cost without a decrease found to date in oncologic efficacy. A growing menu of options exists for secondary androgen deprivation after disease progression on primary therapy: these include high-dose antiandrogens, estrogens, and adrenal androgen suppressants. ADT is being used with increasing frequency as primary monotherapy in patients with localized disease, but only small, nonrandomized studies of highly selected patients have been reported to date. Neoadjuvant ADT (NADT) has been demonstrated in prospective, multi-institutional trials to improve outcomes for patients with high-risk or locally advanced disease undergoing external-beam radiotherapy. Trials for patients with lower-risk, localized disease are still ongoing. Neoadjuvant therapy does not improve outcomes for patients with localized disease opting for radical prostatectomy (RP) and has not been well studied in association with brachytherapy. The side effects of ADT can be managed increasingly successfully; in particular, the introduction of zoledronate may reduce the impact of ADT-associated osteoporosis. Finally, contemporary practice pattern data suggest that use of ADT is increasing across patient risk groups, both in contexts where such therapy is well supported by current evidence and in others where it is not.
Combination of Radiation Therapy and Short-Term Androgen Blockade With Abiraterone Acetate Plus Prednisone for Men With High- and Intermediate-Risk Localized Prostate Cancer. [2021]Long-term androgen-deprivation therapy (ADT) is the standard of care in combination with radiation therapy (RT) in high-risk prostate cancer (PC), despite substantial toxicity from the resulting hypogonadism. We hypothesized that a combination of more potent but shorter-term androgen inhibition in men with intermediate- or high-risk localized PC would synergize with definitive RT to provide short-term testosterone recovery and improve disease control.
Radiotherapy with or without androgen deprivation therapy in intermediate risk prostate cancer? [2020]Androgen deprivation therapy (ADT) is beneficial for unfavorable intermediate-risk (IR) prostate cancer patients receiving curative radiotherapy (RT). However, for favorable IR patients the latest NCCN guidelines recommends RT alone. We retrospectively studied treatment patterns and outcomes of patients with IR prostate cancer in our institution over the past two decades.
Second generation anti-androgens and androgen deprivation therapy with radiation therapy in the definitive management of high-risk prostate cancer. [2023]Evolving data suggest that men with high-risk localized prostate cancer may benefit from more potent androgen receptor inhibition in the context of curative intent radiotherapy. Recently updated American Society for Clinical Oncology (ASCO) evidence-based guidelines and the National Comprehensive Cancer Network (NCCN) Guidelines have updated recommendations for the consideration of adding second generation anti-androgens to androgen deprivation therapy (ADT) in men receiving radiation therapy (RT) for noncastrate locally advanced high and very high risk nonmetastatic or node positive prostate cancer.
Androgen deprivation therapy: minimizing exposure and mitigating side effects. [2019]Despite common and occasionally serious side effects, androgen deprivation therapy (ADT) is widely used in the management of prostate cancer at all stages and presentations. ADT is frequently used in situations in which evidence of benefit is lacking, such as combined with definitive radiotherapy for favorable-risk prostate cancer, or in the primary management of elderly patients with low-risk disease. In intermediate- and high-risk disease, the role of ADT is being challenged and is decreasing in importance, as the ability to deliver very high biologically effective doses becomes more widely available, especially through the combination of external radiotherapy and brachytherapy. Appropriately selecting patients for ADT according to established indications will minimize the number exposed, whereas systematic patient education before initiating treatment can ameliorate the side effects. Minimizing the exposure to ADT and efforts to mitigate the side effects may have a beneficial effect on quality of life for many men with prostate cancer.
Androgen deprivation therapy toxicity and management for men receiving radiation therapy. [2021]Androgen deprivation therapy is commonly used in combination with radiotherapy as part of the definitive treatment for men with clinically localized and locally advanced prostate cancer. Androgen deprivation has been associated with a wide range of iatrogenic effects impacting a variety of body systems including metabolic, musculoskeletal, cardiovascular, neurocognitive, and sexual. This review aims to provide the radiation oncology community with the knowledge to monitor and manage androgen deprivation therapy toxicity in an effort to provide the highest level of care for patients and to minimize the iatrogenic effects of androgen deprivation as much as possible.
Mechanisms, Challenges, and Opportunities in Combined Radiation and Hormonal Therapies. [2022]Androgen receptor signaling blockade is perhaps the first example of targeted therapy in the treatment of cancer. Since the initial observations that prostate cancers depend on hormone signaling, hormonal therapies remain a cornerstone in the treatment of metastatic prostate cancer. Androgen deprivation therapy has been shown to improve outcomes involving treatment of prostate cancers with radiotherapy, though a mechanistic understanding into the optimal sequencing of androgen deprivation therapy and radiotherapy remains incomplete. In this review we highlight key clinical trials designed to study combinations of hormonal and radiotherapies and introduce recent discoveries into the complex biology of androgen receptor signaling and DNA damage and repair. These emerging mechanistic and translational studies may have profound implications on both our understanding of hormonal therapy and radiotherapy combinations and the development of novel treatment strategies for locally-advanced and metastatic castrate resistant prostate cancer.
Efficacy and Prognostic Factors of Androgen Deprivation Therapy Combined with Radiation Therapy for Prostate Cancer. [2022]To analyze the efficacy of androgen deprivation therapy (ADT) combined with radiation therapy (also known as radiotherapy) for prostate cancer.
The androgen receptor for the radiation oncologist. [2015]Androgen deprivation therapy is widely used in combination with radiotherapy for the treatment of prostate cancer. The knowledge of the biology of the androgen axis could help the radiation oncologist to combine both modalities in an efficient way. Moreover, new drugs have recently been approved and their role in combination with radiation needs pre-clinical and clinical studies. This review summarized the main data on the biology of androgen receptor and the potential implications for the physician. Mechanisms of interactions between androgen deprivation therapy and radiotherapy are also presented and discussed.
The use of Hormonal Therapy to Augment Radiation Therapy in Prostate Cancer: An Update. [2018]Androgen deprivation therapy (ADT) is an important adjunctive therapy to external beam radiation therapy (RT) for the definitive management of prostate cancer. The role of ADT is well-established for locally advanced or high-risk disease in conjunction with standard doses of RT, but less defined for intermediate-risk disease or with dose-escalated RT. The goal of this review is to summarize evidence evaluating the combination of ADT/RT, focusing on recent trials and current controversies as they pertain to the practicing clinician.