Nav: Home

Pre-salvage RT PSA predictive of hormone therapy benefit with salvage RT for recurrent prostate cancer

September 16, 2019

Initial results of NRG Oncology Clinical Trial RTOG 9601 in men with biochemically recurrent prostate cancer receiving salvage radiotherapy (SRT) demonstrated improvement in OS from the addition of long-term hormone therapy to SRT. However, a secondary analysis indicates that all patients do not benefit and the addition of long-term anti-androgen therapy did not improve overall survival (OS) rates and could increase other-cause mortality (OCM) for some patients depending on pre-treatment PSA level. Data now shows that pre-SRT prostate-specific antigen (PSA) was a prognostic and predictive biomarker in determining the benefit of the addition of anti-androgen therapy to early SRT. These results were presented during the plenary session of the American Society of Radiation Oncology's (ASTRO) Annual Meeting in September 2019. The abstract is one of four abstracts chosen from over 3,000 submitted abstracts for the plenary session.

NRG-RTOG 9601 was a randomized clinical trial that compared SRT followed by two years of anti-androgen treatment or a placebo in men with biochemically recurrent prostate cancer. Trial participants were randomly assigned to one of the two treatment arms. Results of the initial trial demonstrated improvement in OS from the addition of long-term hormone therapy to SRT at a median follow-up of 13 years. However, the patient population enrolled on this trial was representative of patients in the late 1990s, but patients today are usually treated at much lower PSAs closer to the time of biochemical recurrence. Given the known side effects of hormone therapy, including worsening of cardiac disease, the question becomes in a more representative population of patients receiving early salvage RT at lower PSAs would there still be net benefit. Thus, a secondary analysis of NRG-RTOG 9601 was designed to address if pre-SRT PSA could serve as a prognostic and predictive biomarker of benefit from hormone therapy.

Patients on NRG-RTOG 9601 were stratified by entry PSA (0.2-1.5 vs >1.5-4.0 ng/mL) and randomly assigned to receive either nonsteroidal anti-androgen therapy (bicalutamide) or placebo for two years. 760 patients were evaluable following treatment and 85% percent of those patients were in the pre-SRT PSA of ?1.5 ng/mL stratum. There was no statistically significant overall survival benefit for men with PSAs ?1.5 ng/mL (HR 0.87 [95%CI 0.66-1.16]).Furthermore, men with PSAs <0.6 ng/mL not only had no improvement in overall survival, but experienced an increase in OCM (sHR:1.94, [1.17-3.20]) and higher grade 3-5 cardiac events from bicalutamide. Importantly, as shown in the original NEJM report, there is a large survival benefit from the addition of hormone therapy for men with PSAs >1.5 ng/mL (HR 0.45 [0.25-0.81]).

"Further research is needed to determine which patients receiving early SRT will benefit from hormone therapy. The currently enrolling NRG Oncology clinical trial NRG-GU006 is designed to address this question by measuring the biochemical progression-free survival rates men with post-prostatectomy PSA recurrences who previously received SRT. Men on this trial will either receive SRT alone or a combination of SRT followed by next-generation anti-androgen therapy," stated Daniel Spratt, MD, of the University of Michigan and the lead author of the secondary analysis of NRG-RTOG 9601 and co-principal investigator of NRG-GU006.
This project was supported by grants U10CA180868 (NRG Oncology Operations) and U10CA180822 (NRG Oncology SDMC) from the National Cancer Institute (NCI).


Spratt D, Dess RT, Efstathiou J, Zietman A, Wallington DG, Jairath NK, Jackson WC, Den RB, Stish B, Morgan TM, Dignam JJ, Pisanksy T, Rosenthal SA, Michalski J, Sartor O, Feng FY, Sandler HM, Schipper MJ, Sun Y, Shipley, WU. (2019, September). Two Years of Anti-Androgen Treatment Increases Other-Cause Mortality in Men Receiving Early Salvage Radiotherapy: A Secondary Analysis of the NRG Oncology/RTOG 9601 Randomized Phase III Trial. Paper presented at the annual meeting of the American Society for Radiation Oncology, Chicago, IL.

About NRG Oncology

NRG Oncology conducts practice-changing, multi-institutional clinical and translational research to improve the lives of patients with cancer. Founded in 2012, NRG Oncology is a Pennsylvania-based nonprofit corporation that integrates the research of the legacy National Surgical Adjuvant Breast and Bowel Project (NSABP), Radiation Therapy Oncology Group (RTOG), and Gynecologic Oncology Group (GOG) programs. The research network seeks to carry out clinical trials with emphases on gender-specific malignancies, including gynecologic, breast, and prostate cancers, and on localized or locally advanced cancers of all types. NRG Oncology's extensive research organization comprises multidisciplinary investigators, including medical oncologists, radiation oncologists, surgeons, physicists, pathologists, and statisticians, and encompasses more than 1,300 research sites located world-wide with predominance in the United States and Canada. NRG Oncology is supported primarily through grants from the National Cancer Institute (NCI) and is one of five research groups in the NCI's National Clinical Trials Network.

NRG Oncology

Related Hormone Therapy Articles:

Prolonged use of hormone therapy may minimize muscle loss associated with aging
Skeletal muscle mass and strength are critical in helping prevent falls, fractures, and disability.
Reducing the side-effects of prostate hormone therapy with exercise
A prescription of short-term exercise for patients with advanced prostate cancer could help to reduce the side-effects of hormone therapy, according to new research.
Hormone therapy associated with improved cognition
Estrogen has a significant role in overall brain health and cognitive function.
Why do estradiol levels vary among women using hormone therapy?
CLEVELAND, Ohio (September 24, 2019)--The benefits of hormone therapy (HT) on atherosclerosis relates to achieved estradiol levels among those women who initiate HT early in postmenopause.
Hormone therapy linked to decrease level of diabetes biomarkers
The Women's Health Initiative (WHI) remains one of the most highly quoted when debating the benefits and risks of hormone therapy.
Ribociclib plus hormone therapy extends survival for patients with premenopausal advanced hormone receptor-positive breast cancer
Adding the targeted therapy ribociclib to hormone therapy significantly improved overall survival (OS) in premenopausal patients with advanced hormone receptor-positive (HR+) breast cancer, according to results of the MONALEESA-7 Phase III clinical trial led by researchers at The University of Texas MD Anderson Cancer Center.
Hormone therapy may be best defense against knee osteoarthritis
There is an ongoing debate regarding the relationship between knee osteoarthritis and hormone therapy (HT), with small-scale studies providing mixed results.
Hormone therapy for 'low T' may not be safe for all men
Boosting testosterone levels with hormone supplements may not be safe or appropriate for all men with low testosterone (low T), according to new research.
Artery hardening and thickness not affected by stopping hormone therapy
Heart disease is still the number one killer of US women, and hormone therapy remains a top treatment for menopause symptoms.
Hormone therapy may lead to improved cognitive function
Hormones affect just about everything that goes on in a woman's body, from reproductive function and sexual libido to weight gain and overall mood.
More Hormone Therapy News and Hormone Therapy Current Events

Trending Science News

Current Coronavirus (COVID-19) News

Top Science Podcasts

We have hand picked the top science podcasts of 2020.
Now Playing: TED Radio Hour

Teaching For Better Humans 2.0
More than test scores or good grades–what do kids need for the future? This hour, TED speakers explore how to help children grow into better humans, both during and after this time of crisis. Guests include educators Richard Culatta and Liz Kleinrock, psychologist Thomas Curran, and writer Jacqueline Woodson.
Now Playing: Science for the People

#556 The Power of Friendship
It's 2020 and times are tough. Maybe some of us are learning about social distancing the hard way. Maybe we just are all a little anxious. No matter what, we could probably use a friend. But what is a friend, exactly? And why do we need them so much? This week host Bethany Brookshire speaks with Lydia Denworth, author of the new book "Friendship: The Evolution, Biology, and Extraordinary Power of Life's Fundamental Bond". This episode is hosted by Bethany Brookshire, science writer from Science News.
Now Playing: Radiolab

Dispatch 3: Shared Immunity
More than a million people have caught Covid-19, and tens of thousands have died. But thousands more have survived and recovered. A week or so ago (aka, what feels like ten years in corona time) producer Molly Webster learned that many of those survivors possess a kind of superpower: antibodies trained to fight the virus. Not only that, they might be able to pass this power on to the people who are sick with corona, and still in the fight. Today we have the story of an experimental treatment that's popping up all over the country: convalescent plasma transfusion, a century-old procedure that some say may become one of our best weapons against this devastating, new disease.   If you have recovered from Covid-19 and want to donate plasma, national and local donation registries are gearing up to collect blood.  To sign up with the American Red Cross, a national organization that works in local communities, head here.  To find out more about the The National COVID-19 Convalescent Plasma Project, which we spoke about in our episode, including information on clinical trials or plasma donation projects in your community, go here.  And if you are in the greater New York City area, and want to donate convalescent plasma, head over to the New York Blood Center to sign up. Or, register with specific NYC hospitals here.   If you are sick with Covid-19, and are interested in participating in a clinical trial, or are looking for a plasma donor match, check in with your local hospital, university, or blood center for more; you can also find more information on trials at The National COVID-19 Convalescent Plasma Project. And lastly, Tatiana Prowell's tweet that tipped us off is here. This episode was reported by Molly Webster and produced by Pat Walters. Special thanks to Drs. Evan Bloch and Tim Byun, as well as the Albert Einstein College of Medicine.  Support Radiolab today at