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About ยท curated by Nick Boehling, MD ยท @nb2276

2026-10-22

digest generated 2026-10-23

RTOG 9601: 24mo bicalutamide 150mg added to salvage RT lifts 12-yr OS 76.3% vs 71.3% (HR 0.77) in pN0 post-RP pts, PSA 0.2-4.0.
Prostate carried the day: RTOG 9601's OS gain from adding bicalutamide to salvage RT concentrates at entry PSA โ‰ฅ0.7 (post hoc; HR 1.13 at <0.7), and focal salvage HDR for radiorecurrence (F-SHARP) posts 3-yr bPFS 62.7% with no acute G3+. Seminoma data favor smaller RT fields: Classen 6-yr RFS 95.3% (IIA); nodal mapping places 99% of nodes within a vascular CTV.

Germ Cell / Other GU

Two seminoma datasets back reduced RT fields for stage II disease, one with long-term outcomes, one a recurrence map only.

Early signal

Nodal metastasis mapping in seminoma (RT fields)

ForCS IIA/B or recurrent CS I seminoma post-orchiectomy, nodes โ‰ค5cm

TL;DRAcross 145 imaging-positive nodes in 90 pts, 99% sat within a 2.5cm lateral/posterior and 2.1cm anterior arterial expansion, smaller than Classen fields.

Why it mattersRadiation oncology

The superior border is the volume lever: no left-sided node sat above L1 or in the renal hilum, supporting a border 1.5cm above the left renal artery rather than T10/T11. Prior inguinal or pelvic surgery is the exception, needing an inferior border 1cm below the femoral head.

Monday clinic

In CS IIA/B seminoma with a left-sided primary and no prior inguinal or scrotal surgery, this supports a vascular-referenced CTV without right paracaval or high superior extension; it does not extend to pts with prior pelvic surgery, where inguinal coverage was needed. The longer read

9 details

Retrospective multicenter imaging review, 4 academic centers, staging scans read by a single abdominal radiologist. Each node transferred to a CT template by its relation to the aorta and renal arteries, with craniocaudal scaling for height.

90 pts, CS IIA/B or recurrent CS I seminoma after orchiectomy, nodes โ‰ค5cm. 40 (44%) relapsed on CS I surveillance at a median 8.5 mo (range 3.2-50.4); 50 (56%) node-positive within 3 mo of diagnosis. 48 (53%) left-sided, 41 (46%) right-sided primaries.

Proposed CTV: 2.5cm lateral/posterior and 2.1cm anterior expansion of arterial vasculature, superior border 1cm above the right or 1.5cm above the left renal artery. Classen acetabular inferior border retained; NCCN 2cm GTV boost and setup margins added on top.

145 nodes, average 1.6 per pt, median size 18 mm. 99% of nodes fell inside the proposed expansion; nodal region was unrelated to CS at presentation (P = 0.16) or primary laterality (P = 0.15).

Region% of all nodes% of pts with โ‰ฅ1 node
Para-aortic84%88%
Common iliac9%12%
Pelvic7%9%

Classen extended fields (prospective phase II, 2003) are the NCCN- and European consensus-endorsed standard; this map supports Classen's acetabular inferior border but argues the T10/T11 superior border overtreats. MRC TE10 linked smaller fields to less acute GI toxicity and leukopenia. Martin et al. used a 1.4cm aorta/IVC expansion from non-enlarged nodal anatomy.

infradiaphragmatic CS IIA/B or surveillance-relapse seminoma with nodes โ‰ค5cm and no prior pelvic surgery
Does not represent CS IIC/III disease, pts with prior scrotal or inguinal surgery, or right-sided primaries with renal hilar spread.

Single-timepoint CT in many pts, so original nodal position before reaching size criteria was estimated, not observed. Two atypical nodes (1.4%) were excluded from the expansion analysis. Relapses that would emerge outside the reduced field after treatment are unmeasured.

The case for smaller fields rests on second-malignancy risk in a young cohort, with extended fields linked to up to 50% more SMNs than PA strip fields in cited data. The trade the authors accept is a small out-of-field relapse risk, judged salvageable, against lower SMN risk.

Retrospective imaging-defined node map; proposed CTV never tested for relapse or toxicity. Authors themselves limit it to research use pending validation.

  • Out-of-field relapse rate when treating the vascular-based CTV prospectively
  • Does nanoparticle MRI identify nodes before size criteria change target volumes?

Sourced from Paly, Jonathan J. et al.

๐Ÿ“š Sources ยท ๐Ÿ“„ 1 paper
๐Ÿ“„ PAPER Paly, Jonathan J.; Efstathiou, Jason A.; Hedgire, Sandeep S. et al. ยท Radiotherapy and Oncology (2013-01)
Mapping patterns of nodal metastases in seminoma: Rethinking radiotherapy fields
Early signal

Classen reduced-portal RT for stage IIA/B seminoma

ForPure seminoma, Royal Marsden stage IIA/IIB, AFP-negative, post-orchiectomy

TL;DR6-yr RFS 95.3% (IIA) and 88.9% (IIB) with para-aortic/ipsilateral high iliac RT, 30/36 Gy; 100% in-field control, no late toxicity.

Why it mattersRadiation oncology

Field size is the transferable parameter: dropping the contralateral pelvis and inguinal chain to a T11-to-acetabulum hockey-stick gave no pelvic or inguinal failures and 100% in-field control. 3 of 4 relapses involved the mediastinum, outside any infradiaphragmatic field, so the residual risk is systemic, not a portal or dose problem.

Monday clinic

In AFP-negative stage IIA seminoma, this supports para-aortic plus ipsilateral high iliac RT to 30 Gy without pelvic or mediastinal extension; it does not settle stage IIB, where 21 pts and a 74.4% lower CI bound leave room for chemo-based approaches. The longer read

11 details 1 trial watching

Prospective multicentre observational study, 30 German centres, enrolment April 1991 to March 1994. 94 enrolled, 87 assessable, median follow-up 70 mo. Analysed ITT, including 22 pts with major protocol violations.

Histologically confirmed pure testicular seminoma, Royal Marsden stage IIA (<2 cm) or IIB (2-5 cm) after high inguinal orchiectomy. Elevated AFP excluded; ฮฒHCG up to 200 IU/L allowed after year 1. 66 IIA, 21 IIB; median age 32.5 and 32.

AP/PA hockey-stick to para-aortic/paracaval and ipsilateral high iliac nodes, gross disease plus 2 cm margin, T11 to acetabular rim. 2.0 Gy/fx: 30 Gy for IIA, 36 Gy for IIB, no boost; 5 pts treated bilateral iliac.

Primary: relapse-free survival at 5 years. Secondary: disease-specific survival (expected at least 95% at 5 yr) and acute/late GI and skin toxicity.

Acute toxicity dominated by grade 1 nausea (53% IIA, 52% IIB); no grade 4. No late GI toxicity, no peptic ulceration, no second malignancy to date; one pt with G1 skin hyperpigmentation.

Prior stage II series used larger portals covering the entire ipsilateral iliac/inguinal chain and contralateral pelvis; this cohort shows the reduced field loses no pelvic control. The source places modified EP (9% relapse, 33% G3/4 leukopenia) and carboplatin alone (15% failure) as no better on control with more toxicity.

AFP-negative pure seminoma, stage IIA/IIB by Royal Marsden, treated with infradiaphragmatic RT
Does not represent bulky stage IIC+, nonseminoma, or pts unsuitable for platinum salvage.

Study was not designed to test reduced vs extended portals, so the toxicity advantage is inferred against historic series. Seven pts lost to follow-up were excluded rather than censored, and the IIB cohort is too small for its own protocol-violation analysis.

Failures were all extra-field (mediastinal or lung) except one lateral para-aortic field-edge relapse, and all were salvaged, so DSS was 100%. The authors suggest room for dose reduction below 30 Gy in IIA, though no dose-response relationship was established.

MeasureStage IIAStage IIB
Assessable pts6621
Dose30 Gy36 Gy
6-yr RFS (95% CI)95.3% (88.9-100%)88.9% (74.4-100%)
Relapse sites1 mediastinal, 1 field-edge1 mediastinal, 1 mediastinal/pulmonary
G3 nausea8%10%
G3 diarrhea6%10%

Single-arm observational cohort with no randomised comparator vs chemo; IIB subset small (n=21). Single-arm gate caps the verdict despite 70-mo follow-up.

  • Dose de-escalation below 30 Gy in stage IIA
  • RT vs chemotherapy in stage IIB seminoma
    n=90 ยท primary completion 2032-05 ยท post-1 EP randomised RT boost vs carbo, stratified IIA/IIB
  • Second-malignancy risk beyond 6-yr follow-up

Sourced from Classen, Johannes et al.

๐Ÿ“š Sources ยท ๐Ÿ“„ 1 paper
๐Ÿ“„ PAPER Classen, Johannes; Schmidberger, Heinz; Meisner, Christoph et al. ยท Journal of Clinical Oncology (2003-03)
Radiotherapy for Stages IIA/B Testicular Seminoma: Final Report of a Prospective Multicenter Clinical Trial
Abstract
Purpose: A prospective multicenter trial was initiated to evaluate the role of modern radiotherapy with reduced treatment portals for stage IIA and IIB testicular seminoma. Patients and Methods: Patients with stages IIA/B disease (Royal Marsden classification) were assessable for the trial. Staging comprised computed tomography of the chest, abdomen, and pelvis as well as analysis of tumor markers alpha-fetoprotein and beta human chorionic gonadotropin. Linac-based radiotherapy was delivered to para-aortic and high ipsilateral iliac lymph nodes. The total doses were 30 Gy for stage IIA and 36 Gy for stage IIB disease. Results: Between April 1991 and March 1994, 94 patients were enrolled for the trial by 30 participating centers throughout Germany. Seven patients were lost to follow-up. Median time to follow-up of 87 assessable patients was 70 months. There were 66 stage IIA and 21 stage IIB patients. One mediastinal and one field-edge relapse were observed in the stage IIA group. In the stage IIB group, there was one mediastinal and one mediastinal/pulmonary relapse. All patients were treated with a salvage regimen of platinum-based chemotherapy. Actuarial relapse-free survival at 6 years was 95.3% (95% confidence interval [CI], 88.9% to 100%) and 88.9% (95% CI, 74.4% to 100%) for stage IIA and IIB groups, respectively. Maximum acute side effects were 8% grade 3 nausea for stage IIA and 10% grade 3 nausea and diarrhea for stage IIB groups. No late toxicity was observed. Conclusion: Radiotherapy for stages IIA/B seminoma with reduced portals yields excellent tumor control at a low rate of acute toxicity and no late toxicity, which supports the role of radiotherapy as the first treatment choice for these patients.

Prostate

Salvage throughout: systemic add-on to prostate-bed RT, focal HDR re-irradiation for radiorecurrence, plus an SBRT margin audit.

Early signal

F-SHARP

ForIntraprostatic radiorecurrence after definitive RT for localized prostate cancer

TL;DRNo acute G3+ toxicity and 3-yr bPFS 62.7% after dose-escalated focal salvage HDR (up to 30 Gy/1-2 fx) for intraprostatic radiorecurrence, N=62.

Why it mattersRadiation oncology

The single-fraction arm (24 pts) matched two fractions on every endpoint (all P > .05), making a one-visit focal salvage HDR schedule a real option. The GC tail is the second read: all 4 pts with score >0.85 recurred locally and distantly, so focal-only salvage looks like the wrong tool for them.

Monday clinic

In intraprostatic radiorecurrence after definitive RT, this supports focal salvage HDR (up to 30 Gy in 1-2 fractions) as a low-toxicity local option; it does not settle management for the GC score >0.85 pt, where focal salvage alone failed in all 4. The longer read

12 details

Multi-institutional phase I/II, single-arm, N = 62. Median follow-up 39.4 mo.

Intraprostatic radiorecurrence (IPR) after any form of RT for localized prostate cancer. GC results available in 31 pts.

Dose-escalated focal salvage HDR, up to 30 Gy in 1-2 fractions. 24 pts received one fraction and 38 received two.

Primary: acute RT-related G3+ GU and GI toxicity (CTCAE v4.03). Secondary: all-grade toxicity, QoL (EPIC-26, IPSS), bPFS, rPFS, LRFS, MFS and survival.

No acute G3 toxicity. Late G3 toxicity in 2 pts (3.2%); QoL changes did not meet MCID criteria.

Prospective salvage brachytherapy data after EBRT are sparse, with RTOG 0526 testing whole-gland salvage LDR in this setting. F-SHARP adds a focal, dose-escalated HDR approach and a genomic risk layer that prior salvage series lacked.

pts with intraprostatic radiorecurrence after definitive RT treated with focal salvage HDR
Does not represent pts with extraprostatic or nodal recurrence, or whole-gland salvage.

The GC analysis is restricted to 31 of 62 pts and the >0.85 cutpoint rests on n = 4, so it is a descriptive tail, not a validated threshold. The 1 vs 2 fraction comparison was not randomized and is underpowered for equivalence.

Toxicity is the settled part: focal dose escalation to 30 Gy in the re-irradiated gland produced no acute G3 events. Durability is the open part, since bPFS at 3 yr is 62.7% and the efficacy endpoints carry no comparator.

Endpoint3-yr rate
bPFS62.7%
rPFS67.5%
LRFS73.0%
MFS85.9%

Single-arm phase I/II, N=62, toxicity primary objective; efficacy endpoints secondary and uncontrolled. GC signal from half the cohort.

  • Focal vs whole-gland salvage brachytherapy for intraprostatic radiorecurrence
  • Does GC-guided intensification improve outcomes in high-score pts?
  • Is single-fraction focal salvage HDR equivalent to two fractions?

Sourced from Solanki, Abhishek A. et al.

๐Ÿ“š Sources ยท ๐Ÿ“„ 1 paper
๐Ÿ“„ PAPER Solanki, Abhishek A.; Adams, William; Proudfoot, James A. et al. ยท Journal of Clinical Oncology (2026-10)
Dose-Escalated Focal Salvage High-Dose-Rate Brachytherapy and Genomic Classifier Risk Stratification in Radiorecurrent Prostate Cancer: The F-SHARP Phase I/II Clinical Trial
Abstract
Purpose Prospective data on the management of intraprostatic radiorecurrence (IPR) after definitive radiotherapy (RT) and use of genomic classifiers (GC) in this setting are limited. We hypothesized that dose-escalated focal salvage high-dose-rate brachytherapy (DE-fsHDR) would be safe and effective, and that GC would risk stratify patients who may benefit from treatment intensification. Methods F-SHARP is a multi-institutional phase I/II trial of DE-fsHDR for IPR after any form of RT for localized prostate cancer. Patients received up to 30 Gy in 1-2 fractions. The primary objective was to determine the acute RT-related grade โ‰ฅ3 CTCAE v4.03 genitourinary and GI toxicity rates. Secondary end points included all-grade toxicity, quality of life (QoL; EPIC-26 and International Prostate Symptom Score), disease control, and survival. GC analysis used a clinical-grade transcriptome assay (Veracyte, San Diego, CA). Time-to-event outcomes included biochemical progression-free survival (bPFS), radiographic progression-free survival (rPFS), local recurrence-free survival (LRFS), and metastasis-free survival (MFS). Results Twenty-four participants received one fraction and 38 received two fractions (N = 62). The median follow-up was 39.4 months. No acute grade 3 toxicities occurred. Two patients (3.2%) had late grade 3 toxicity. QoL changes did not meet criteria for a minimal clinically important difference. Three-year survival rates were 62.7% (bPFS), 67.5% (rPFS), 73.0% (LRFS), and 85.9% (MFS); there were no differences between fractionation groups (all P &gt; .05). Among 31 patients with GC results, higher scores were associated with worse bPFS, rPFS, LRFS, and MFS. All patients with GC score &gt;0.85 (n = 4) experienced biochemical, local, and metastatic recurrence. Conclusion DE-fsHDR is a safe and effective salvage treatment for IPR. GC score is a promising prognostic tool in patients undergoing salvage local therapy for IPR and warrants further study to guide treatment intensification.
๐Ÿ“ https://ascopubs.org/doi/10.1200/JCO-25-02730
Early signal

Prostate SBRT intra-fraction motion and margins

ForProstate SBRT 36.25 Gy/5 fx, fiducial CBCT IGRT, no intra-fraction tracking

TL;DRCurrent 6 mm/3 mm posterior PTV margins covered IFPM in 92% of fractions. BIR-guideline margins ran from 3.3 mm laterally and posteriorly to 7.0 mm inferiorly.

Why it mattersRadiation oncology

The 7.0 mm inferior margin is driven mainly by apex delineation error on MRI-only contours, and dropping one outlier contour gives 5.8 mm. Lateral margins of 3.3 and 3.5 mm suggest room to trim. The posterior miss (6 of 97 fractions past 3 mm) sits at the rectal edge, which argues for bladder/rectal consistency or tracking rather than a wider posterior PTV.

Monday clinic

In fiducial-guided 36.25 Gy/5 fx prostate SBRT delivered without intra-fraction tracking, this supports existing 6 mm/3 mm posterior margins as covering most fractions; it does not inform tracked, MR-guided, or CT-only-delineated workflows. The longer read

13 details 2 trials watching

Retrospective single-centre audit of 97 pre/post-treatment CBCT pairs from 20 pts. Margins were calculated from IFPM alone and with the updated BIR geometric uncertainty guidelines.

36.25 Gy in 5 fractions SBRT without intra-fraction tracking, with fiducial-based daily online CBCT IGRT. Current margins were 6 mm isotropic, 3 mm posterior. Mean pre- to post-imaging interval was 9 min.

magnitude and direction of IFPM and coverage by current margins. Secondary: margins derived from IFPM alone and from the BIR guidelines.

Averaged 3D RMS IFPM was 2.5 mm (4.2 mm), mostly posterior (70%) and inferior (63%). Current margins covered 92% of fractions, and 8 of 97 exceeded them, six posteriorly.

DirectionCurrent marginBIR-derived margin
Right6 mm3.5 mm
Left6 mm3.3 mm
Superior6 mm3.7 mm
Inferior6 mm7.0 mm
Anterior6 mm4.4 mm
Posterior3 mm3.3 mm

The authors report RL motion above comparable CBCT series, with AP and SI comparable. A larger cited margin study (n=205) found smaller systematic errors and similar random errors.

fiducial-matched, CBCT-verified 5 fx prostate SBRT without real-time tracking
Does not represent tracked or MR-guided delivery, or CT/fused-image delineation workflows.

Delineation error, the dominant component, came from an MRI-only study and is probably smaller than real CT or fused MR/CT error. Deformation was set to 0, match error was assumed rather than measured, and AP and SI were not split by direction.

The guideline-derived numbers suggest lateral margins could shrink while the inferior margin grows, but the inferior increase rests heavily on one outlier contour. The authors advise checking outcomes in current trials before changing practice, given favourable control and toxicity with existing margins.

Single-centre retrospective geometric audit, n=20, no clinical outcome endpoint; proposed margin changes are untested against toxicity or biochemical control.

Sourced from McNeice, Joseph M et al.

๐Ÿ“š Sources ยท ๐Ÿ“„ 1 paper
๐Ÿ“„ PAPER McNeice, Joseph M; Sanilkumar, Nandu; Alexander, Sophie E et al. ยท The British Journal of Radiology (2023-06)
Prostate stereotactic body radiotherapy: quantifying intra-fraction motion and calculating margins using the new BIR geometric uncertainties in daily online IGRT recommendations
Abstract
Objectives: To measure the magnitude of intra-fraction prostate motion (IFPM) during stereotactic radiotherapy (SBRT) delivered without intra-fraction tracking. To assess if current margins adequately cover IFPM. To derive margins using new guidelines. Methods: IFPM was determined in 20 patients receiving 36.25 Gy in 5 fractions using 97 pairs of pre- and post-treatment cone beam CT (CBCT) scans. Correlation of time between CBCT acquisitions and motion was determined. The magnitude of IFPM was compared to current margins (6 mm isotropic, 3 mm posterior). Margins were calculated using IFPM alone and updated guidelines. Results: The averaged 3D root mean square IFPM was 2.5 mm (4.2 mm). Independent prostate motion was predominantly posterior (70%) and inferior (63%). There was weak correlation between posterior (ฯ = 0.38) and inferior (ฯ = 0.36) IFPM and time. IFPM greater than current margins occurred in 8 of 97 fractions, six in the posterior direction. Margins were โ‰ค3.5 mm using IFPM alone and โ‰ค3.3 mm Left 3.5 mm Right, 7.0 mm inferior, 3.7 mm superior, 4.4 mm anterior and 3.3 mm posterior using new guidelines, compensating for motion in 92% of fractions. Conclusions: Our current SBRT margins account for 92% of IFPM, predominantly posterior and inferior. Although updated guidelines suggest an increase in margins inferiorly, any increase must be balanced against the possibility of increased toxicity, particularly if biochemical control and side-effects are favourable with current practice. Advances in knowledge: The difference between current clinical margins and those determined using updated guidance is demonstrated. The implications must be considered against clinical outcomes.
Confirmatory

RTOG 9601 NCT00002874

ForpN0 pT2 R1/pT3 post-RP, detectable PSA 0.2-4.0 ng/ml, salvage RT

Overall survival

HR 0.77

95% CI 0.59-0.99, P=0.04; 12-yr OS 76.3% vs 71.3%

TL;DR12-yr OS 76.3% vs 71.3%, HR 0.77 (0.59-0.99), adding 24mo bicalutamide 150mg to salvage RT in pN0 post-RP pts with PSA 0.2-4.0.

Why it mattersRadiation oncology

The benefit follows pre-SRT PSA: 12-yr OS HR 0.45 (0.25-0.81) above 1.5 ng/ml and 0.61 at 0.7-1.5, but HR 1.13 (0.77-1.65) below 0.7, where the median entry PSA of 0.6 sat. RT was prostate bed only, 64.8 Gy/36 fx, so this informs hormone addition separately from the pelvic nodal coverage decision.

Monday clinic

In a pN0 man after RP heading to salvage RT with PSA above 0.7 ng/ml, this supports adding hormone therapy to bed RT; it does not extend to PSA below 0.7 ng/ml, where the post hoc OS HR was 1.13. The longer read

11 details 1 trial watching

Randomized, double-blind, placebo-controlled NRG/RTOG trial; 840 randomized 1998-2003, 760 eligible analyzed (384 vs 376). Median follow-up 13 years among survivors.

Post-RP with lymphadenectomy, pT2 with positive margin or pT3, pN0, detectable PSA 0.2-4.0 ng/ml at least 8 weeks after surgery. No prior RT or chemo; prior hormones limited to short preoperative courses (6.4%). Staging by CT and bone scan.

Bicalutamide 150 mg daily for 24 months vs placebo, starting with RT. Adherence โ‰ฅ18 months was 69.8% vs 74.7%.

64.8 Gy in 36 fractions of 1.8 Gy to the prostatic bed and membranous urethra, 6-10 MV photons, 2D or 3D planning. Pelvic nodes omitted because all dissections were negative. QA: 64.8% per protocol, 4.4% unacceptable variation.

Primary: overall survival. Secondary: disease-specific death, distant metastases, local progression, non-disease-specific death, second biochemical recurrence, AEs.

Primary met; every disease-control endpoint favored bicalutamide (table). The OS gain is concentrated at entry PSA โ‰ฅ0.7 ng/ml in post hoc subgroups.

EndpointRT + bicalutamideRT + placeboHR (95% CI), P
OS (1ยฐ EP)76.3%71.3%0.77 (0.59-0.99), P=0.04
Death from PCa5.8%13.4%0.49 (0.32-0.74), P<0.001
Metastatic PCa14.5%23.0%0.63 (0.46-0.87), P=0.005
2nd biochemical recurrence44.0%67.9%0.48 (0.40-0.58), P<0.001
PSA at entryn (%)BicalutamidePlaceboHR (95% CI), P
<0.7 ng/ml405 (53.3)76.8%80.7%1.13 (0.77-1.65), 0.53
0.7-1.5 ng/ml237 (31.2)77.0%67.5%0.61 (0.39-0.95), 0.03
>1.5 ng/ml118 (15.5)73.5%48.9%0.45 (0.25-0.81), 0.007

Gynecomastia 69.7% vs 10.9%. Late GU G3 7.0% vs 6.0%; no excess early bladder, bowel or hematologic toxicity, and no excess non-disease-specific death.

SPPORT and RADICALS-HD tested GnRH-based ADT with salvage RT, but neither used a placebo-controlled OS design. The Early Prostate Cancer Program trials of the same drug and dose reported a matching gynecomastia signal (68% vs 8%).

pN0 men after RP with a detectable PSA up to 4.0 ng/ml receiving prostate-bed salvage RT
Does not represent PSMA-staged, node-positive, or very-low-PSA early salvage pts, or GnRH-agonist regimens.

Post-randomization exclusion of 79 ineligible pts departs from strict ITT. Cardiac events were captured only as reported AEs, which risks ascertainment bias. Pre-PSMA staging leaves occult extra-field disease in the cohort.

OS benefit is real but risk-adapted: below PSA 0.7 the subgroup trended the other way. The open questions are whether a modern GnRH agonist reproduces the effect and which duration is enough.

CONSORT flow
Randomized840
โ†“
RT + bicalutamide
allocated 419
analyzed 384
12-yr OS 76.3%
RT + placebo
allocated 421
analyzed 376
12-yr OS 71.3%

Double-blind placebo-controlled RCT, OS primary met at 13y median f/u. Benefit concentrated at PSA โ‰ฅ0.7 (post hoc); bicalutamide 150mg since superseded by GnRH agonists.

Sourced from Shipley, William U. et al.

๐Ÿ“š Sources ยท ๐Ÿ“„ 1 paper
๐Ÿ“„ PAPER Shipley, William U.; Seiferheld, Wendy; Lukka, Himanshu R. et al. ยท New England Journal of Medicine (2017-02)
Radiation with or without Antiandrogen Therapy in Recurrent Prostate Cancer