Lancet 2016 Mar 19
Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial.
Related Questions
Does Decipher provide any additional value in determining whether patients with metastatic hormone sensitive prostate cancer should receive chemotherapy?
Docetaxel has been part of the treatment paradigm for metastatic androgen pathway inhibitor-sensitive prostate cancer since the CHAARTED and STAMPEDE trials showed its value in addition to standard ADT, particularly in patients with "high volume" disease based on clinical features/lesion number from...
Do you offer either zoledronic acid or denosumab for patients with mCSPC with lytic metastases at baseline due to intraductal histology or high grade pathology?
This is an interesting question that we do not directly have evidence for. I usually do not offer patients bone protective therapy in this setting. Bone-protective therapy, in my opinion, is beneficial in preventing fractures, really for two reasons: Pathologic fractures. mAPMS disease (formerly mC...
In a patient with very high risk prostate cancer opting for prostatectomy, when, if ever, do you recommend neoadjuvant ADT?
I generally do not offer ADT with or without a potent ARSI prior to RP even in high risk disease. While small single arm studies have shown that a few such men can achieve a pathologic CR and that path CR/MRD is associated with better outcomes after RP, for most patients, this approach has no clear ...
Would you treat the prostate in a patient with widely metastatic disease who has CR to all metastatic sites after systemic therapy or ADT?
This is an interesting hypothesis, but requires further study before offering. The trials that define a benefit to prostate RT in the metastatic setting (HORRAD, STAMPEDE, and now PEACE-1) did not use response-adapted selection criteria. Therefore, we cannot say that radiation to the prostate in an ...
Would you give ADT + docetaxel -> darolutamide for a low risk castrate sensitive metastatic prostate cancer patient given ARASENS results?
ARASENS was designed during the era of docetaxel plus ADT emerging as the standard of care for men with mHSPC irrespective of disease volume, based on the improved OS observed in STAMPEDE for a largely de novo mHSPC patient population, where there was no heterogeneity observed for the OS benefit in ...
In light of ARASENS presented at GU ASCO 2022, how do you approach treatment of de novo metastatic hormone sensitive prostate cancer?
There are multiple factors that go into treatment decisions for men with mHSPC, but two of the most important are volume of disease and de novo vs relapsed disease (i.e. prior local therapy). Volume of disease is one of the major factors for deciding on the benefits of docetaxel, with very limited b...
Do you consider ADT intensification with enzalutamide or abiraterone in patients receiving adjuvant radiation with ADT?
I agree with Dr. @Dr. First Last.One thing to note is ~3% of RADICALS, for example, included pT3b and high grade disease, and almost no patients in the ART vs SRT trials had N+ disease. Was largely GS7 and pT3a population and not the very high risk patients that select surgeons choose to operate on....
How would you treat a patient with Gleason 8 or 9 prostate cancer, pretreatment PSA 15-24, with retroperitoneal adenopathy?
I would offer a similar approach to that described nicely by @Dr. First Last and @Dr. First Last: definitive RT+ADT+abiraterone, with SIB to the grossly positive nodes. My caveats and additions are: I start with a frank discussion with the patient re: evidence for various scenarios and general prog...
For a very high risk prostate cancer with relatively no elevation in PSA but no distant or nodal metastasis would you consider “neoadjuvant” ADT and chemotherapy prior to EBRT?
This is a very challenging scenario in dealing with men who have M0 N0 but very high risk disease with a Gleason 10 (grade group 5) locally advanced tumor. Recent data supports a very poor outcome for these low PSA high grade patients when treated with IMRT and ADT alone (Mahal BA et al Eur Urol 201...
Would you treat prostate cancer with hormone sensitive metastatic recurrence (after local treatment) the same as de novo metastatic hormone sensitive disease?
Yes, most of the phase 3 trials (ARCHES, ENZAMET, TITAN, STAMPEDE) permitted relapsed mHSPC patients in addition to de novo mHSPC patients. LATITUDE was the only trial that required newly diagnosed patients with mHSPC. For the AR inhibitors, a similar benefit in delaying radiographic progression or ...
Are you using prostate PET imaging for any newly-diagnosed prostate cancers?
December 2021 Update:In 2 years since this original post, a lot has changed. Two different PSMA PET/CT companies have gained FDA approval with broad indications that include the use in newly diagnosed men at risk for harboring metastatic disease. Distribution is well underway with many centers now h...
Would you use abiraterone or docetaxel in addition to ADT and radiotherapy for patients with very high risk, node-negative prostate cancer?
The most recent update from STAMPEDE's abiraterone arm in the M0 N0 very high risk setting was reported here: Attard et al., PMID 34953525 and strongly suggests that abi/ADT for 2 years plus radiation improves MFS and OS significantly and should be standard of care for men who are choosing RT in thi...
Is there a role for a salvage lymph node dissection in patients who present with a biochemical failure after prostatectomy?
It's an important question without randomized data to support an answer. Even this question will evolve as we bring on-board more advanced imaging such as Fluciclovine PET/CT, PSMA PET, etc. These scans are continuuing to introduce new challenges as we start to resolve the location of lesions and so...
What are the safest dose constraints for moderately hypofractionated prostate cancer?
At Penn, we have a protocol for 70 Gy/28 fractions using proton or photon therapy for low- and intermediate-risk patients. I initially designed it with a conedown as follows, but that is not always necessary/appropriate. CTV Initial = Prostate and proximal seminal vesicles to include at least 1 cm, ...
Per 2016 NCCN guidelines, is the addition of 6 cycles docetaxel now the standard of care for all (NCCN) high and very-high risk prostate cancer patients receiving definitive XRT/ADT?
Last year, the results of RTOG 0521 were presented at ASCO and showed that adjuvant docetaxel led to a small improvement in overall survival for men with high risk prostate cancer. To briefly recap, 563 eligible subjects were randomized to standard-of-care external beam RT (72-75.6Gy, with 46.8 to r...
Is there a role for docetaxel for men with high risk prostate cancer receiving radiation and androgen deprivation therapy?
Standard of care for high risk localized prostate cancer remains radiation and long term androgen deprivation therapy. To date, there are no trials that have demonstrated an overall survival benefit with the addition of chemotherapy. Given the potential toxicity of adding chemotherapy, this should n...
When is the best time to start denosumab in men with metastatic prostate cancer?
The data supporting the use of bone modifying agents (BMAs) such as denosumab or zoledronic acid are certainly the most solid for men with castration-resistant prostate cancer (i.e. progresion of disease through inital LHRH analog therapy) (Saad, JNCI 2004; 94: 1458–68; Fizzazi Lancet Oncol 2011; 37...