Radiotherapy + Androgen Deprivation Therapy for Prostate Cancer
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 not be taking: Antiandrogens, LHRH agonists
Disqualifiers: Prior pelvic radiotherapy, Androgen ablation, Metastatic disease, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?The Miami UAdapt Trial is a non-comparative, risk adapted, parallel, randomized, phase 2 study for patients with favorable-intermediate to very high risk non-metastatic prostate cancer with the primary objective of assessing the efficacy and modulation of response of Lattice Extreme Ablative Dose (LEAD) RT with and without androgen deprivation therapy (ADT) at a multidimensional level.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on anti-androgen therapy or androgen deprivation therapy, there are specific timing requirements for starting these treatments during the trial.
What data supports the effectiveness of the treatment combining radiotherapy and androgen deprivation therapy for prostate cancer?
Research shows that combining androgen deprivation therapy (ADT) with radiation therapy (RT) improves overall survival and reduces the risk of cancer progression in prostate cancer patients. Dose-escalated radiotherapy, when combined with ADT, has been associated with better outcomes compared to standard-dose radiotherapy alone.
12345Is the combination of radiotherapy and androgen deprivation therapy safe for prostate cancer patients?
Research shows that combining radiotherapy with androgen deprivation therapy (ADT) for high-risk prostate cancer can lead to both acute (short-term) and late (long-term) side effects, but it is generally considered safe. Studies have reported that ADT can reduce the risk of cancer returning and spreading, although patients may experience side effects related to hormone therapy and radiation.
26789What makes the Radiotherapy + Androgen Deprivation Therapy treatment for prostate cancer unique?
This treatment combines radiotherapy with androgen deprivation therapy (ADT), which reduces male hormone levels to slow cancer growth. The unique aspect is the use of Lattice Extreme Ablative Dose (LEAD) radiotherapy, which delivers very high doses of radiation to specific tumor areas, potentially enhancing the effectiveness of the treatment compared to standard radiotherapy approaches.
210111213Eligibility Criteria
Men aged 35-85 with confirmed adenocarcinoma of the prostate, stages T1-T3, Gleason score 6-10, and PSA ≤100 ng/mL. They must have no evidence of metastasis or prior pelvic radiotherapy/prostate surgery and be able to consent. Those with concurrent active cancers (except certain skin cancers/early-stage leukemia) or a history of cancer in remission for less than 5 years are excluded.Inclusion Criteria
The projected duration must not exceed 30 months.
I can't have iodine or gadolinium contrast because of an allergy or kidney issues but can still join.
My MRI shows a suspicious area in my prostate.
+18 more
Exclusion Criteria
I have had or am planning to have major prostate surgery.
My scans show cancer spread to small lymph nodes or distant areas, making me ineligible for FTLEAD but possibly for HypoLEAD.
I don't have any active cancer except for non-spreading skin cancer or early-stage CLL.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Lattice Extreme Ablative Dose (LEAD) RT with or without ultra short-term androgen deprivation therapy (ADT), followed by hypofractionated RT
Up to 14 months
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of biochemical disease failure and treatment-related toxicity
5.5-8 years
Participant Groups
The UAdapt Trial is testing single high-dose radiotherapy (SDRT) on patients with favorable and unfavorable risk prostate cancer. It includes standard ADT care, FTLEAD, HypoLEAD treatments, and ultra-short-term Androgen Deprivation Therapy using Relugolix to see if they prevent disease failure one year post-radiotherapy.
4Treatment groups
Experimental Treatment
Group I: Lattice extreme ablative dose followed by hypofractionated RT (HypoLEAD), uSTADT, Arm DExperimental Treatment4 Interventions
Participants in this group will receive LEAD RT with ultra short-term ADT followed by moderately hypofractionated RT (HypoLEAD) and standard of care ADT and will be followed for 5.5-8 years.
Group II: Lattice extreme ablative dose followed by hypofractionated RT (HypoLEAD), Arm CExperimental Treatment3 Interventions
Participants in this group will receive LEAD RT followed by moderately hypofractionated RT (HypoLEAD) and standard of care androgen deprivation therapy and will be followed for 5.5-8 years.
Group III: Focal Therapy lattice extreme ablative dose (FTLEAD), uSTADT, Arm BExperimental Treatment2 Interventions
Participants in this group will receive the FTLEAD treatment and ultra short-term androgen deprivation therapy (ADT) and will be followed for up to 5.5 years.
Group IV: Focal Therapy lattice extreme ablative dose (FTLEAD), RT Only, Arm AExperimental Treatment1 Intervention
Participants in this group will receive the FTLEAD treatment only and will be followed for up to 5.5 years.
FTLEAD is already approved in United States for the following indications:
🇺🇸 Approved in United States as Lattice Extreme Ablative Dose (LEAD) RT for:
- Non-metastatic 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
Varian Medical SystemsIndustry Sponsor
References
Technological advances in radiotherapy for the treatment of localised prostate cancer. [2006]There is good evidence that radiation dose escalation in localised prostate cancer is associated with increased cell kill. The traditional two-dimensional (2D) technique of treatment planning and delivery is limited by normal tissue toxicity, such that the dose that can be safely delivered to the prostate by external beam radiotherapy is 65-70 Gy. Several technological advances over the last 20 years have enhanced the precision of external beam radiotherapy (EBRT), and have resulted in improved outcomes. The three-dimensional conformal radiotherapy (3D-CRT) approach reduces the dose-limiting late side-effect of proctitis and has allowed for dose escalation to the whole prostate to 78 Gy. More recently, intensity modulated radiotherapy (IMRT), an advanced form of conformal therapy, has resulted in reduced rectal toxicity when using doses greater than 80 Gy. In addition, IMRT can potentially escalate the dose to specific parts of the prostate where there are resistant subpopulations of tumour clonogens, or can be used to extend the high-dose region to pelvic lymph nodes. The addition of androgen deprivation to conventional radiotherapy has an impact on survival and local control. Initial hormone therapy causes cytoreduction of the prostate cancer allowing for a reduction in radiotherapy volume as well as an additive effect on cell kill. Long-term adjuvant androgen deprivation has been shown to improve overall survival in more advanced tumours. Prostate brachytherapy is now a recognised treatment for those with low-risk disease. It achieves similar long-term outcome to other treatment modalities. Brachytherapy can be used as monotherapy for localised disease, or as boost treatment following conventional EBRT for locally advanced disease. New techniques are available to improve the precision of both target definition and treatment verification. This so-called image-guided radiotherapy will help to enhance the accuracy of dose delivery by correcting both for inter-fraction positional variation and for intra-fraction movement of the prostate in real-time and will allow for tighter tumour margins and avoidance of normal tissues, thereby enhancing the safety of treatment.
Assessing the Optimum Use of Androgen-Deprivation Therapy in High-Risk Prostate Cancer Patients Undergoing External Beam Radiation Therapy. [2022]The optimum use of androgen deprivation therapy (ADT) in high-risk prostate cancer patients has not been defined in the setting of dose-escalated external beam radiation therapy. A retrospective analysis of 1,290 patients with high-risk prostate cancer from June 1987 through March 2010 treated with external beam radiation therapy was performed. Median follow-up was 7.2 years, and 797 patients received ADT, with 384 patients experiencing a biochemical failure and 145 with distant metastasis. ADT was associated with lower risk of biochemical failure and distant metastasis than no ADT after adjusting for age, prostate-specific antigen (PSA), Gleason score, year of diagnosis, tumor stage, and radiation dose. ADT was associated with a greater reduction in biochemical failure in the low-dose radiation group than in the high-dose group. Patients with >24 months of ADT had a lower risk of PSA failures than those with 24 months of ADT in all patients who received ADT.
A Phase 3 Trial of 2 Years of Androgen Suppression and Radiation Therapy With or Without Adjuvant Chemotherapy for High-Risk Prostate Cancer: Final Results of Radiation Therapy Oncology Group Phase 3 Randomized Trial NRG Oncology RTOG 9902. [2022]Long-term (LT) androgen suppression (AS) with radiation therapy (RT) is a standard treatment of high-risk, localized prostate cancer (PCa). Radiation Therapy Oncology Group 9902 was a randomized trial testing the hypothesis that adjuvant combination chemotherapy (CT) with paclitaxel, estramustine, and oral etoposide plus LT AS plus RT would improve overall survival (OS).
Adding Short-Term Androgen Deprivation Therapy to Radiation Therapy in Men With Localized Prostate Cancer: Long-Term Update of the NRG/RTOG 9408 Randomized Clinical Trial. [2023]For men with localized prostate cancer, NRG Oncology/Radiation Therapy Oncology Group (RTOG) 9408 demonstrated that adding short-term androgen deprivation therapy (ADT) to radiation therapy (RT) improved the primary endpoint of overall survival (OS) and improved disease-specific mortality (DSM), biochemical failure (BF), local progression, and freedom from distant metastases (DM). This study was performed to determine whether the short-term ADT continued to improve OS, DSM, BF, and freedom from DM with longer follow-up.
The impact of dose-escalated radiotherapy plus androgen deprivation for prostate cancer using 2 linked nomograms. [2021]Randomized trials have demonstrated that escalated-dose external-beam radiotherapy (EDRT) is better than standard-dose radiotherapy (SDRT) for patients with prostate cancer and that adding androgen-deprivation therapy (ADT) to SDRT is better than SDRT alone; however, no trials have compared EDRT versus SDRT plus ADT or EDRT versus EDRT plus ADT. The authors designed a model to estimate the results of various doses of radiotherapy (RT) combined with various durations of ADT.
Increasing external beam dose for T1-T2 prostate cancer: effect on risk groups. [2007]The aim of this study was to investigate effect of increasing dose on risk groups for clinical failure (CF: local failure or distant failure or hormone ablation or PSA>or=25 ng/ml) in patients with T1-T2 prostate cancer treated with external beam radiotherapy.
Management of high-risk prostate cancer: radiation therapy and hormonal therapy. [2013]The prognosis of high-risk prostate cancer is poor with a high mortality rate. The Radiation Therapy Oncology Group (RTOG) has performed dose-escalation studies of external beam radiation therapy (EBRT) and has developed high-precision radiation therapy (RT) methods such as intensity-modulated RT, carbon ion therapy, and proton beam therapy. High-dose rate brachytherapy (HDR-BT) is also studied as an option for high-risk prostate cancer treatment. Past clinical trials have suggested that the local control rate of high-risk prostate cancer improves with total EBRT dose, even for doses > 70 Gy. Several randomized controlled trials, including RTOG 94-06, have shown significantly better prognoses with higher doses (> 75 Gy) than with lower doses ( 2 years) HT combined with definitive RT. Further studies are warranted to elucidate optimal irradiation doses, HT treatment durations, and combination therapy schedules.
Acute and late toxicity in high-risk prostate cancer patients treated with androgen suppression and hypofractionated pelvic radiation therapy. [2018]To report acute and late toxicity rates in patients with high-risk prostate cancer treated with androgen deprivation therapy (ADT) and moderate hypofractionated radiation therapy (HypoRT) to the prostate and nodal areas.
Hypofractionated accelerated radiotherapy using concomitant intensity-modulated radiotherapy boost technique for localized high-risk prostate cancer: acute toxicity results. [2018]To evaluate the acute toxicities of hypofractionated accelerated radiotherapy (RT) using a concomitant intensity-modulated RT boost in conjunction with elective pelvic nodal irradiation for high-risk prostate cancer.
Dose escalation of external beam radiotherapy for high-risk prostate cancer-Impact of multiple high-risk factor. [2022]To retrospectively investigate the treatment outcomes of external beam radiotherapy with androgen deprivation therapy (ADT) in high-risk prostate cancer in three radiotherapy dose groups.
Long-term androgen deprivation, with or without radiotherapy, in locally advanced prostate cancer: updated results from a phase III randomised trial. [2020]To report the long-term oncological outcomes of a randomised trial comparing androgen-deprivation therapy (ADT) combined with external beam radiation therapy (EBRT) and ADT alone in patients with locally advanced prostate cancer.
Next Generation of Androgen Deprivation Therapy Combined With Radiotherapy for N0 M0 Prostate Cancer. [2021]Androgen deprivation therapy in combination with definitive radiation therapy is a standard of care for both intermediate-/high-risk localized prostate, locally advanced prostate cancer. Newer hormonal therapies have shown promising results in patients with castration-resistant disease and are now being investigated in early stages, in combination with radiation therapy. In this section, we review the body of evidence elucidating the mechanism of synergy and immune modulation effect of androgen deprivation therapy and radiation therapy, summarize the pivotal studies supporting its use in the nonmetastatic setting, and present the ongoing studies who will likely shape the management of locally advanced disease, in the upcoming years.
Optimal Androgen Deprivation Therapy Combined with Proton Beam Therapy for Prostate Cancer: Results from a Multi-Institutional Study of the Japanese Radiation Oncology Study Group. [2020]Androgen deprivation therapy (ADT) combined with radiation therapy benefits intermediate- and high-risk prostate cancer (PC) patients. The optimal ADT duration in combination with high-dose proton beam therapy (PBT) remains unknown.