Radiation and Hormone Therapy for Prostate Cancer
(DIVINE Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Mayo Clinic
Must be taking: Androgen deprivation
Must not be taking: Chemotherapy, Androgen inhibitors
Disqualifiers: Pregnancy, Active infection, Heart failure, others
No Placebo Group
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?This phase II trial studies the effects of stereotactic body radiation therapy (SBRT) and the timing of treatment with androgen receptor pathway inhibitor (ARPI) plus androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate cancer that has spread from where it first started to other places in the body (metastatic), and that has come back after a period of improvement (recurrent). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Androgen can cause the growth of prostate cells. ADT lowers the amount of androgen made by the body. This may help stop the growth of tumor cells that need androgen to grow. Androgen receptor pathway inhibitors work by blocking the effects of androgen to stop the growth and spread of tumor cells. Giving SBRT alone with watchful waiting may be as effective in treating prostate cancer as giving SBRT together with ARPI and ADT.
Do I need to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you have been on androgen receptor pathway inhibitors in the last 2 years, you may not be eligible to participate.
What data supports the effectiveness of the treatment Stereotactic Ablative Radiotherapy (SABR) for prostate cancer?
Research shows that SABR, especially using the CyberKnife system, is promising for treating prostate cancer, including cases that are intermediate- to very-high-risk. It has been found to potentially improve survival and delay further spread in patients with certain types of prostate cancer.
12345Is the combination of radiation and hormone therapy for prostate cancer safe?
Research on stereotactic ablative radiotherapy (SABR) using CyberKnife for prostate cancer shows it is generally safe, with very few severe side effects reported. Some patients experienced mild to moderate gastrointestinal (stomach and intestines) and genitourinary (urinary and reproductive organs) reactions, but serious long-term effects were rare.
14678How is the treatment Stereotactic Body Radiation Therapy (SBRT) unique for prostate cancer?
Stereotactic Body Radiation Therapy (SBRT), also known as Stereotactic Ablative Radiotherapy (SABR), is unique because it uses the CyberKnife system to deliver highly precise radiation to prostate cancer, even in cases with advanced or oligometastatic disease. This method allows for targeted treatment with fewer sessions compared to traditional radiation, potentially improving survival and reducing the risk of further cancer spread.
125910Eligibility Criteria
This trial is for men with hormone-sensitive prostate cancer that has spread and returned after improving. Participants should not have allergies to the treatments used in the study, which include various medications and radiation therapy.Inclusion Criteria
Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x upper limit of normal (ULN) ( ≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)
I have up to 5 cancer spread sites, with at least one outside my pelvis.
Willingness to provide mandatory blood specimens for correlative research
+12 more
Exclusion Criteria
I have received chemotherapy for prostate cancer.
I had surgery less than 3 weeks ago.
Pregnant persons
+16 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Patients undergo SBRT and receive ARPI and ADT for up to 6 months, with cycles repeating every 4 months
6 months
Regular visits for treatment and monitoring
Watchful Waiting
Patients are monitored for disease progression after treatment
Until disease progression
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to 5 years
Follow-up every 6 months
Participant Groups
The DIVINE Trial is testing how well stereotactic body radiation therapy (SBRT) works alone or when combined with ARPIs and ADT in treating metastatic, recurrent prostate cancer. It compares different treatment timings to see which is more effective.
2Treatment groups
Experimental Treatment
Active Control
Group I: Group B (SBRT, watchful waiting)Experimental Treatment8 Interventions
Patients undergo SBRT with watchful waiting. Cycles repeat every 4 months (16 weeks) in the absence of disease progression or unacceptable toxicity.
Group II: Group A (SBRT, APRI, ADT)Active Control19 Interventions
Patients undergo SBRT and receive APRI (abiraterone and prednisone, apalutamide, darolutamide, or enzalutamide) and ADT (leuprolide, triptorelin, histrelin, goserelin, degarelix, or relugolix). Cycles repeat every 4 months (16 weeks) for up to 6 months in the absence of unacceptable toxicity. Patients then undergo watchful waiting thereafter until disease progression.
Stereotactic Body Radiation Therapy is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as Stereotactic Body Radiation Therapy for:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
🇪🇺 Approved in European Union as Stereotactic Body Radiation Therapy for:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
🇨🇦 Approved in Canada as Stereotactic Body Radiation Therapy for:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
🇦🇺 Approved in Australia as Stereotactic Body Radiation Therapy for:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
References
Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. [2017]Recent clinical reports of stereotactic ablative radiotherapy (SABR) in the treatment of low-risk prostate cancer have been encouraging. Our study evaluates the efficacy and safety of SABR using the CyberKnife system for treating intermediate- to very-high-risk prostate cancer.
Survival Outcomes and Pattern of Relapse After SABR for Oligometastatic Prostate Cancer. [2022]The addition of stereotactic ablative radiotherapy (SABR) to standard of care for patients with oligometastatic prostate cancer has the potential of improving survival and delaying further metastases. The primary aim of this analysis is to report survival outcomes and pattern of recurrence of patients with hormone-sensitive (HSPC) and castrate-resistant (CRPC) oligometastatic prostate cancer treated with SABR.
Two versus five stereotactic ablative radiotherapy treatments for localized prostate cancer: A quality of life analysis of two prospective clinical trials. [2020]Stereotactic ablative radiotherapy (SABR) is appealing for prostate cancer (PCa) due to low α/β, and increasing the dose per fraction could improve the therapeutic index and lead to a better quality of life (QOL). Here we report the outcomes of a QOL comparison between two phase II clinical trials: two vs. five fraction prostate SABR.
Dose-Intensified Stereotactic Ablative Radiation for Localized Prostate Cancer. [2022]Stereotactic ablative radiation (SAbR) has been increasingly used in prostate cancer (PCa) given its convenience and cost efficacy. Optimal doses remain poorly defined with limited prospective comparative trials and long-term safety/efficacy data at higher dose levels. We analyzed toxicity and outcomes for SAbR in men with localized PCa at escalated 45 Gy in 5 fractions.
Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial. [2022]Stereotactic ablative body radiotherapy (SABR) is an emerging treatment option for oligometastatic prostate cancer. However, limited prospective evidence is available.
Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. [2022]We evaluated the effectiveness and safety of stereotactic ablative radiotherapy (SABR) delivered using Cyberknife in patients with stage I non-small-cell lung cancer.
Cyberknife Radioablation of Prostate Cancer – Preliminary Results for 400 Patients [2020]Objectives: To evaluate the tolerance and effectiveness of stereotactic ablative radiotherapy (SABR) applied in the treatment of low and intermediate risk (LR & IR) prostate cancer patients (PCP) and provide an evaluation of the level of risk group impact on treatment results. In addition, androgen deprivation therapy (ADT) usage and prostatic specific antigen (PSA) decline after SABR were assessed. Material and Methods: A total of 400 PCP (213 LR and 187 IR, including T2c) were irradiated with a CyberKnife using fd 7.25 Gy to TD 36.25 Gy. At the start of treatment, 60.3% of patients were undergoing ADT and this gradually decreased to 0% after 38 months. Follow-up was for a median of 15.0 months. Patients were monitored on SABR completion and 1, 4, 8 months later and then subsequently every 6 months. GI (Gastro-Intestinal) and GU (Genito-Urinary) acute and late adverse effects, PSA and ADT usage were evaluated. Results: Failure was noted in 9 patients (2.25%) (5 in LR and 4 in IR groups) - 4 relapses and 5 nodal metastases. No G3/4 late adverse effects (EORTC/RTOG) were observed. Some 0.5% of G3 GU and 0.3% of G3 GI acute reactions were noted respectively on the SABR completion day and one month later. The median of PSA declined 1.5 ng/ml during the first month and 0.6 ng/ml during the next three months. No impact of risk groups on treatment results was found. An impact of ADT on PSA decline was only confirmed for time point interactions. Conclusions: SABR for LR and IR PCP is a safe and effective treatment. The inclusion of T2c patients and the low percentage of IR patient failure permit us the assumption that this procedure could be utilized in the treatment of more advanced cases. The results do not allow clear definition of the impact of ADT on radioablation results in LR and IR+ T2c cases.
Image-guided stereotactic body radiation therapy for localized prostate cancer. [2022]We report the results of a retrospective study of stereotactic body radiation therapy (SBRT) using CyberKnife for localized prostate cancer. The study focused on the safety and feasibility of this treatment modality.
Dosimetric and patient correlates of quality of life after prostate stereotactic ablative radiotherapy. [2018]Initial results of Stereotactic Ablative Body Radiotherapy (SABR) in the treatment of localized prostate cancer appear promising however long-term quality of life (QOL) outcomes and dosimetric correlates are necessary.
Low incidence of new biochemical and clinical hypogonadism following hypofractionated stereotactic body radiation therapy (SBRT) monotherapy for low- to intermediate-risk prostate cancer. [2022]The CyberKnife is an appealing delivery system for hypofractionated stereotactic body radiation therapy (SBRT) because of its ability to deliver highly conformal radiation therapy to moving targets. This conformity is achieved via 100s of non-coplanar radiation beams, which could potentially increase transitory testicular irradiation and result in post-therapy hypogonadism. We report on our early experience with CyberKnife SBRT for low- to intermediate-risk prostate cancer patients and assess the rate of inducing biochemical and clinical hypogonadism.